Introduction to Clinical Research - II

ByBenhur Pradeep

Pradeepben84gmailcom

wwwmyclinicalresearchbookblogspotcom

What is Clinical Research

bull A systematic observational and experimental biomedical studies performed in human subjects to test new drugs or combination of drugs or devices or biologics for its safety and therapeutic uses or new approaches to surgery or radiotherapy or procedures to improve the diagnosis of disease and the Quality life of the patient

wwwmyclinicalresearchbookblogspotcom

Purpose of Research

bull Intended to increase knowledge about how well a diagnostic test or treatment works in a particular patient population

bull To test hypothesis formulated from observations and or intuition

bull Ultimately to understand better onersquos world and make ldquoSense of itrdquo

wwwmyclinicalresearchbookblogspotcom

New Drug Development ProcessResearch Early Development Full Development Life Cycle

Management

Discovery Phase

Candidate Profiling

Phase

Preclinical Trials

Clinical Trial Phase I Phase IIA Phase IIB Phase III Phase IV

Cand

idat

e Se

lecti

on P

oint

Sele

cted

for P

roof

of

Con

cept

Dev

elop

men

t D

ecis

ion

Poin

t

Full

Dev

elop

men

t Po

int

Phas

e III

Che

ck

Poin

t

Subm

issi

on

Dec

isio

n Po

int

IND NDA

RampDbull Research Targetbull Discovery of Lead

Compoundbull Selection of Suitable

Candidate

Preclinicalbull Lab testingbull Animal Studiesbull Toxicology Studies

etc

Clinical (I amp II)

bull Biological Tests and Pharmacological test in humans

bull Regulatory Clearance

Clinical (IIIampIV)

bull Registration with Health Authorities

bull Preparation for Launchbull Launch and Sales

wwwmyclinicalresearchbookblogspotcom

Ethical Norms in Clinical Research3 ethical principles guide clinical research

bullTreatment of person as autonomous

Respect for Persons

bullPotential conflict between good of society Vs individual

Beneficence

bullTreatment of all fairly and all equally share benefits and risks

Justice

wwwmyclinicalresearchbookblogspotcom

Ethical Norms of Clinical Trials

bull Sound study designs take into accountndash Randomization or sharing of risksndash Proper use of placebo ndash Processes to monitor safety of RxTxndash Competent investigatorsndash Informed consentndash Equitable selection of participantsndash Compensation for study related injuries

wwwmyclinicalresearchbookblogspotcom

Clinical Research - Phases

Determine

metabolic and

pharmacological actions Maximu

m tolerated doses

BA-BE studies Pharmacokinetics

Pharmacodynamics

Up to 1 MonthHealthy Volunteers or

individuals with targeted disease20-100

Subjects

Phase I

Evaluate of

effectiveness

Drug-Disease interactionDrug-Drug interactions

Subject safety

Several MonthsIndividuals with targeted disease200-300 SubjectsPhase II

Additional

information on

effectiveness

Evaluate overall

risk-benefit

ratio

Dosage intervalsEfficacy and safety

Risk-Benefit information

Several Years

Individuals with targeted disease100rsquos ndash 1000rsquos

SubjectsPhase III

Monitor ongoing safety in

large populati

on

Epidemiological dataPharmacoeconomics

Ongoing review

Individuals with targeted disease as well as new

age groups genders

etc1000rsquos

Subjects

Phase IV

wwwmyclinicalresearchbookblogspotcom

Major players in Research team

bull Investigatorbull Clinical Research Associatebull Clinical Research Coordinatorbull Data Managerbull Statisticianbull Patientsbull IRBbull Regulatory Body

wwwmyclinicalresearchbookblogspotcom

Principal Investigator

bull A person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site the investigator is the responsible leader of the team and may be called the principal investigator

wwwmyclinicalresearchbookblogspotcom

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

What is Clinical Research

bull A systematic observational and experimental biomedical studies performed in human subjects to test new drugs or combination of drugs or devices or biologics for its safety and therapeutic uses or new approaches to surgery or radiotherapy or procedures to improve the diagnosis of disease and the Quality life of the patient

wwwmyclinicalresearchbookblogspotcom

Purpose of Research

bull Intended to increase knowledge about how well a diagnostic test or treatment works in a particular patient population

bull To test hypothesis formulated from observations and or intuition

bull Ultimately to understand better onersquos world and make ldquoSense of itrdquo

wwwmyclinicalresearchbookblogspotcom

New Drug Development ProcessResearch Early Development Full Development Life Cycle

Management

Discovery Phase

Candidate Profiling

Phase

Preclinical Trials

Clinical Trial Phase I Phase IIA Phase IIB Phase III Phase IV

Cand

idat

e Se

lecti

on P

oint

Sele

cted

for P

roof

of

Con

cept

Dev

elop

men

t D

ecis

ion

Poin

t

Full

Dev

elop

men

t Po

int

Phas

e III

Che

ck

Poin

t

Subm

issi

on

Dec

isio

n Po

int

IND NDA

RampDbull Research Targetbull Discovery of Lead

Compoundbull Selection of Suitable

Candidate

Preclinicalbull Lab testingbull Animal Studiesbull Toxicology Studies

etc

Clinical (I amp II)

bull Biological Tests and Pharmacological test in humans

bull Regulatory Clearance

Clinical (IIIampIV)

bull Registration with Health Authorities

bull Preparation for Launchbull Launch and Sales

wwwmyclinicalresearchbookblogspotcom

Ethical Norms in Clinical Research3 ethical principles guide clinical research

bullTreatment of person as autonomous

Respect for Persons

bullPotential conflict between good of society Vs individual

Beneficence

bullTreatment of all fairly and all equally share benefits and risks

Justice

wwwmyclinicalresearchbookblogspotcom

Ethical Norms of Clinical Trials

bull Sound study designs take into accountndash Randomization or sharing of risksndash Proper use of placebo ndash Processes to monitor safety of RxTxndash Competent investigatorsndash Informed consentndash Equitable selection of participantsndash Compensation for study related injuries

wwwmyclinicalresearchbookblogspotcom

Clinical Research - Phases

Determine

metabolic and

pharmacological actions Maximu

m tolerated doses

BA-BE studies Pharmacokinetics

Pharmacodynamics

Up to 1 MonthHealthy Volunteers or

individuals with targeted disease20-100

Subjects

Phase I

Evaluate of

effectiveness

Drug-Disease interactionDrug-Drug interactions

Subject safety

Several MonthsIndividuals with targeted disease200-300 SubjectsPhase II

Additional

information on

effectiveness

Evaluate overall

risk-benefit

ratio

Dosage intervalsEfficacy and safety

Risk-Benefit information

Several Years

Individuals with targeted disease100rsquos ndash 1000rsquos

SubjectsPhase III

Monitor ongoing safety in

large populati

on

Epidemiological dataPharmacoeconomics

Ongoing review

Individuals with targeted disease as well as new

age groups genders

etc1000rsquos

Subjects

Phase IV

wwwmyclinicalresearchbookblogspotcom

Major players in Research team

bull Investigatorbull Clinical Research Associatebull Clinical Research Coordinatorbull Data Managerbull Statisticianbull Patientsbull IRBbull Regulatory Body

wwwmyclinicalresearchbookblogspotcom

Principal Investigator

bull A person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site the investigator is the responsible leader of the team and may be called the principal investigator

wwwmyclinicalresearchbookblogspotcom

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Purpose of Research

bull Intended to increase knowledge about how well a diagnostic test or treatment works in a particular patient population

bull To test hypothesis formulated from observations and or intuition

bull Ultimately to understand better onersquos world and make ldquoSense of itrdquo

wwwmyclinicalresearchbookblogspotcom

New Drug Development ProcessResearch Early Development Full Development Life Cycle

Management

Discovery Phase

Candidate Profiling

Phase

Preclinical Trials

Clinical Trial Phase I Phase IIA Phase IIB Phase III Phase IV

Cand

idat

e Se

lecti

on P

oint

Sele

cted

for P

roof

of

Con

cept

Dev

elop

men

t D

ecis

ion

Poin

t

Full

Dev

elop

men

t Po

int

Phas

e III

Che

ck

Poin

t

Subm

issi

on

Dec

isio

n Po

int

IND NDA

RampDbull Research Targetbull Discovery of Lead

Compoundbull Selection of Suitable

Candidate

Preclinicalbull Lab testingbull Animal Studiesbull Toxicology Studies

etc

Clinical (I amp II)

bull Biological Tests and Pharmacological test in humans

bull Regulatory Clearance

Clinical (IIIampIV)

bull Registration with Health Authorities

bull Preparation for Launchbull Launch and Sales

wwwmyclinicalresearchbookblogspotcom

Ethical Norms in Clinical Research3 ethical principles guide clinical research

bullTreatment of person as autonomous

Respect for Persons

bullPotential conflict between good of society Vs individual

Beneficence

bullTreatment of all fairly and all equally share benefits and risks

Justice

wwwmyclinicalresearchbookblogspotcom

Ethical Norms of Clinical Trials

bull Sound study designs take into accountndash Randomization or sharing of risksndash Proper use of placebo ndash Processes to monitor safety of RxTxndash Competent investigatorsndash Informed consentndash Equitable selection of participantsndash Compensation for study related injuries

wwwmyclinicalresearchbookblogspotcom

Clinical Research - Phases

Determine

metabolic and

pharmacological actions Maximu

m tolerated doses

BA-BE studies Pharmacokinetics

Pharmacodynamics

Up to 1 MonthHealthy Volunteers or

individuals with targeted disease20-100

Subjects

Phase I

Evaluate of

effectiveness

Drug-Disease interactionDrug-Drug interactions

Subject safety

Several MonthsIndividuals with targeted disease200-300 SubjectsPhase II

Additional

information on

effectiveness

Evaluate overall

risk-benefit

ratio

Dosage intervalsEfficacy and safety

Risk-Benefit information

Several Years

Individuals with targeted disease100rsquos ndash 1000rsquos

SubjectsPhase III

Monitor ongoing safety in

large populati

on

Epidemiological dataPharmacoeconomics

Ongoing review

Individuals with targeted disease as well as new

age groups genders

etc1000rsquos

Subjects

Phase IV

wwwmyclinicalresearchbookblogspotcom

Major players in Research team

bull Investigatorbull Clinical Research Associatebull Clinical Research Coordinatorbull Data Managerbull Statisticianbull Patientsbull IRBbull Regulatory Body

wwwmyclinicalresearchbookblogspotcom

Principal Investigator

bull A person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site the investigator is the responsible leader of the team and may be called the principal investigator

wwwmyclinicalresearchbookblogspotcom

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

New Drug Development ProcessResearch Early Development Full Development Life Cycle

Management

Discovery Phase

Candidate Profiling

Phase

Preclinical Trials

Clinical Trial Phase I Phase IIA Phase IIB Phase III Phase IV

Cand

idat

e Se

lecti

on P

oint

Sele

cted

for P

roof

of

Con

cept

Dev

elop

men

t D

ecis

ion

Poin

t

Full

Dev

elop

men

t Po

int

Phas

e III

Che

ck

Poin

t

Subm

issi

on

Dec

isio

n Po

int

IND NDA

RampDbull Research Targetbull Discovery of Lead

Compoundbull Selection of Suitable

Candidate

Preclinicalbull Lab testingbull Animal Studiesbull Toxicology Studies

etc

Clinical (I amp II)

bull Biological Tests and Pharmacological test in humans

bull Regulatory Clearance

Clinical (IIIampIV)

bull Registration with Health Authorities

bull Preparation for Launchbull Launch and Sales

wwwmyclinicalresearchbookblogspotcom

Ethical Norms in Clinical Research3 ethical principles guide clinical research

bullTreatment of person as autonomous

Respect for Persons

bullPotential conflict between good of society Vs individual

Beneficence

bullTreatment of all fairly and all equally share benefits and risks

Justice

wwwmyclinicalresearchbookblogspotcom

Ethical Norms of Clinical Trials

bull Sound study designs take into accountndash Randomization or sharing of risksndash Proper use of placebo ndash Processes to monitor safety of RxTxndash Competent investigatorsndash Informed consentndash Equitable selection of participantsndash Compensation for study related injuries

wwwmyclinicalresearchbookblogspotcom

Clinical Research - Phases

Determine

metabolic and

pharmacological actions Maximu

m tolerated doses

BA-BE studies Pharmacokinetics

Pharmacodynamics

Up to 1 MonthHealthy Volunteers or

individuals with targeted disease20-100

Subjects

Phase I

Evaluate of

effectiveness

Drug-Disease interactionDrug-Drug interactions

Subject safety

Several MonthsIndividuals with targeted disease200-300 SubjectsPhase II

Additional

information on

effectiveness

Evaluate overall

risk-benefit

ratio

Dosage intervalsEfficacy and safety

Risk-Benefit information

Several Years

Individuals with targeted disease100rsquos ndash 1000rsquos

SubjectsPhase III

Monitor ongoing safety in

large populati

on

Epidemiological dataPharmacoeconomics

Ongoing review

Individuals with targeted disease as well as new

age groups genders

etc1000rsquos

Subjects

Phase IV

wwwmyclinicalresearchbookblogspotcom

Major players in Research team

bull Investigatorbull Clinical Research Associatebull Clinical Research Coordinatorbull Data Managerbull Statisticianbull Patientsbull IRBbull Regulatory Body

wwwmyclinicalresearchbookblogspotcom

Principal Investigator

bull A person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site the investigator is the responsible leader of the team and may be called the principal investigator

wwwmyclinicalresearchbookblogspotcom

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Ethical Norms in Clinical Research3 ethical principles guide clinical research

bullTreatment of person as autonomous

Respect for Persons

bullPotential conflict between good of society Vs individual

Beneficence

bullTreatment of all fairly and all equally share benefits and risks

Justice

wwwmyclinicalresearchbookblogspotcom

Ethical Norms of Clinical Trials

bull Sound study designs take into accountndash Randomization or sharing of risksndash Proper use of placebo ndash Processes to monitor safety of RxTxndash Competent investigatorsndash Informed consentndash Equitable selection of participantsndash Compensation for study related injuries

wwwmyclinicalresearchbookblogspotcom

Clinical Research - Phases

Determine

metabolic and

pharmacological actions Maximu

m tolerated doses

BA-BE studies Pharmacokinetics

Pharmacodynamics

Up to 1 MonthHealthy Volunteers or

individuals with targeted disease20-100

Subjects

Phase I

Evaluate of

effectiveness

Drug-Disease interactionDrug-Drug interactions

Subject safety

Several MonthsIndividuals with targeted disease200-300 SubjectsPhase II

Additional

information on

effectiveness

Evaluate overall

risk-benefit

ratio

Dosage intervalsEfficacy and safety

Risk-Benefit information

Several Years

Individuals with targeted disease100rsquos ndash 1000rsquos

SubjectsPhase III

Monitor ongoing safety in

large populati

on

Epidemiological dataPharmacoeconomics

Ongoing review

Individuals with targeted disease as well as new

age groups genders

etc1000rsquos

Subjects

Phase IV

wwwmyclinicalresearchbookblogspotcom

Major players in Research team

bull Investigatorbull Clinical Research Associatebull Clinical Research Coordinatorbull Data Managerbull Statisticianbull Patientsbull IRBbull Regulatory Body

wwwmyclinicalresearchbookblogspotcom

Principal Investigator

bull A person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site the investigator is the responsible leader of the team and may be called the principal investigator

wwwmyclinicalresearchbookblogspotcom

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Ethical Norms of Clinical Trials

bull Sound study designs take into accountndash Randomization or sharing of risksndash Proper use of placebo ndash Processes to monitor safety of RxTxndash Competent investigatorsndash Informed consentndash Equitable selection of participantsndash Compensation for study related injuries

wwwmyclinicalresearchbookblogspotcom

Clinical Research - Phases

Determine

metabolic and

pharmacological actions Maximu

m tolerated doses

BA-BE studies Pharmacokinetics

Pharmacodynamics

Up to 1 MonthHealthy Volunteers or

individuals with targeted disease20-100

Subjects

Phase I

Evaluate of

effectiveness

Drug-Disease interactionDrug-Drug interactions

Subject safety

Several MonthsIndividuals with targeted disease200-300 SubjectsPhase II

Additional

information on

effectiveness

Evaluate overall

risk-benefit

ratio

Dosage intervalsEfficacy and safety

Risk-Benefit information

Several Years

Individuals with targeted disease100rsquos ndash 1000rsquos

SubjectsPhase III

Monitor ongoing safety in

large populati

on

Epidemiological dataPharmacoeconomics

Ongoing review

Individuals with targeted disease as well as new

age groups genders

etc1000rsquos

Subjects

Phase IV

wwwmyclinicalresearchbookblogspotcom

Major players in Research team

bull Investigatorbull Clinical Research Associatebull Clinical Research Coordinatorbull Data Managerbull Statisticianbull Patientsbull IRBbull Regulatory Body

wwwmyclinicalresearchbookblogspotcom

Principal Investigator

bull A person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site the investigator is the responsible leader of the team and may be called the principal investigator

wwwmyclinicalresearchbookblogspotcom

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Clinical Research - Phases

Determine

metabolic and

pharmacological actions Maximu

m tolerated doses

BA-BE studies Pharmacokinetics

Pharmacodynamics

Up to 1 MonthHealthy Volunteers or

individuals with targeted disease20-100

Subjects

Phase I

Evaluate of

effectiveness

Drug-Disease interactionDrug-Drug interactions

Subject safety

Several MonthsIndividuals with targeted disease200-300 SubjectsPhase II

Additional

information on

effectiveness

Evaluate overall

risk-benefit

ratio

Dosage intervalsEfficacy and safety

Risk-Benefit information

Several Years

Individuals with targeted disease100rsquos ndash 1000rsquos

SubjectsPhase III

Monitor ongoing safety in

large populati

on

Epidemiological dataPharmacoeconomics

Ongoing review

Individuals with targeted disease as well as new

age groups genders

etc1000rsquos

Subjects

Phase IV

wwwmyclinicalresearchbookblogspotcom

Major players in Research team

bull Investigatorbull Clinical Research Associatebull Clinical Research Coordinatorbull Data Managerbull Statisticianbull Patientsbull IRBbull Regulatory Body

wwwmyclinicalresearchbookblogspotcom

Principal Investigator

bull A person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site the investigator is the responsible leader of the team and may be called the principal investigator

wwwmyclinicalresearchbookblogspotcom

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Major players in Research team

bull Investigatorbull Clinical Research Associatebull Clinical Research Coordinatorbull Data Managerbull Statisticianbull Patientsbull IRBbull Regulatory Body

wwwmyclinicalresearchbookblogspotcom

Principal Investigator

bull A person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site the investigator is the responsible leader of the team and may be called the principal investigator

wwwmyclinicalresearchbookblogspotcom

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Principal Investigator

bull A person responsible for the conduct of the clinical trial at a trial site If a trial is conducted by a team of individuals at a trial site the investigator is the responsible leader of the team and may be called the principal investigator

wwwmyclinicalresearchbookblogspotcom

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Responsibilities Investigator Investigators Qualifications Adequacy of Resources Medical Care of Study Participants Communication with the IRB IEC Compliance with the Protocol Investigational Product care Randomization amp unbinding The Informed Consent Records and Reports Progress Reports Safety Reporting Stopping or suspending a study Final report by investigator

wwwmyclinicalresearchbookblogspotcom

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

CRC

bull Person who handles most of the administrative responsibilities of a clinical trial acts as liaison between investigative site and sponsor and reviews all data and records before a monitorrsquos visit

bull Functions as extension of Investigatorbull Involved in operational duties ndash recruiting

scheduling completing CRFrsquos administering tests

wwwmyclinicalresearchbookblogspotcom

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

CRA (Monitor)

bull A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the progress of the trial and for verification of data

bull The monitor ensures that the trial is conducted recorded and reported in accordance with the Protocol Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and the applicable regulatory requirements

wwwmyclinicalresearchbookblogspotcom

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Responsibilities Monitorbull Main line of communication between sponsor and sitebull Site feasibility Training and supportbull to site staff amp selectionbull Protocol amp GCP Compliancebull Document completeness amp maintenancebull Source Data Verificationbull Trial material accountingbull Ensure timely AE amp SAE reportingbull Monitoring reports amp other office documentationsbull Prepare and assist in IRB Regulatory and internal audit or inspectionbull Assist in IRB and Regulatory Submissionbull Assist in IRB and Regulatory Submission

wwwmyclinicalresearchbookblogspotcom

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Study Start UpProtocol Level Feasibility

Investigator Selection Process

Conducting Pre Study Visits

Investigators Meeting

Site Initiation

Site Monitoring

Study Close out

Site Startup

Study Conduct

Study Completion

wwwmyclinicalresearchbookblogspotcom

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Feasibility Studies

bull Protocol feasibility To assess from the region(s)country(ies) where the clinical study is to be conducted agreement on important study criteria like inclusion exclusion criteria comparator drug and study procedures outlined in the Protocol Synopsis to prevent the need for protocol amendments later in the planning process

bull A secondary objective is to provide information to support finalization of the countryregion allocation

wwwmyclinicalresearchbookblogspotcom

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Feasibility Studiesbull Site feasibility involves assessing site potential based

on multivariate factors like Principal Investigators experience amp interest in Clinical Research patient inflow accessibility to the site availability of patients that meet the study criteria and other related factors that affect the accrual rates and proper conduct of study related activities

bull This is done to ensure that appropriate sitesPrincipal Investigators are identified

wwwmyclinicalresearchbookblogspotcom

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Site Selectionbull It can be defined as a systematic planned process to evaluate

and select an investigator and site for conduct of clinical trial bull Factors involved in selection

ndash Reputation in fieldndash Facilities desirable for trial conductndash Access to patient populationndash Accessible geographic locationndash Anticipated time for initiation and completion of trialndash Relationship with sponsorndash Budgetary factorsndash Past experiencendash Experienced staffndash ECndashability to process protocols fairly and expeditiously

wwwmyclinicalresearchbookblogspotcom

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Investigator Meeting

bull Purposendash Achieve uniformity in approach by all investigators ndash Review and discuss the protocolndash Answer questionsndash Generate enthusiasm ndash Get everyone to know each other and develop a sense of

teamwork and trustndash Review potential difficulties issues and problemsndash Review administrative ground rules

wwwmyclinicalresearchbookblogspotcom

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Site Initiation

bull Study initiation is done to review protocol processes and procedures to ensure that all site personnel understand requirements of trial

bull Sites are initiated after all regulatory amp ethical documentation is complete after IP and other supplies are shipped and before any patients are enrolled

wwwmyclinicalresearchbookblogspotcom

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Monitoring

bull Purposebull 1048729 To verifyndash protection of rights and well-being of subjectsndash reported trial data is accurate complete and verifiablendash trial is in compliance withndash Protocol and amendmentsndash Regulatory requirementsndash Enrolmentndash Drug supply

wwwmyclinicalresearchbookblogspotcom

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Study Close Out

bull After ensuring the study is complete bull All CRF receivedbull All study material is accounted forbull All investigational product is accounted for and

balance returned to sponsorbull Ensure payment completion

wwwmyclinicalresearchbookblogspotcom

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Key IssuesStart Up

bull Delegate responsibilities

bull Educate research team

bull Enrollment planbull Study documents

Conductbull Protocol compliancebull Documentationbull Record retentionbull Trial drug

accountabilitybull Safety reporting

Close Outbull Final drug

accountabilitybull Preparation of

records for archivingbull Storage or

destruction of lab samples

bull Data query resolution

bull Notification to governing regulatory body

wwwmyclinicalresearchbookblogspotcom

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Site Managementbull A structured amp planned approach to manage various

research activitiesfunctions at a site to ensure execution through compliance and strict adherence to safety standards -through periodic monitoring per pre-determinedplanned monitoring plan

Design

Feasibility

Study Start up Execution

Follow up

Close out Reporting

Publication

Site Management

wwwmyclinicalresearchbookblogspotcom

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Study Documentsbull Investigatorrsquos Boucherbull Protocolbull Informed Consent Formbull Case Report Formbull Financial Disclosure Formbull EC Approval Letterbull Clinical Trial Agreements and Budgetbull Lab Normal Rangesbull Sample Labelsbull Pre trial Monitoring Reportbull Signed Agreements between 2 parties

wwwmyclinicalresearchbookblogspotcom

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Process Flow

Proposal of study

Ethics Feasibility significance

Study Protocol

Pre-study planning (Personnel Other

resources EC approvals etc)

Agreements

Investigators meeting practical planning training

Conduct of study Recruitment of the participants Informed

consent Clinical examinations Specimen collection Dispatch

Documentation

Monitoring

Central Lab

Data analysis Correction

Queries

Close the data dispatch of the data archiving

Closing meeting

Evaluation of the study

wwwmyclinicalresearchbookblogspotcom

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you

Thank you

wwwmyclinicalresearchbookblogspotcom

• Introduction to Clinical Research - II
• What is Clinical Research
• Purpose of Research
• New Drug Development Process
• Ethical Norms in Clinical Research
• Ethical Norms of Clinical Trials
• Clinical Research - Phases
• Major players in Research team
• Principal Investigator
• Responsibilities Investigator
• CRC
• CRA (Monitor)
• Responsibilities Monitor
• Study Start Up
• Feasibility Studies
• Feasibility Studies (2)
• Site Selection
• Investigator Meeting
• Site Initiation
• Monitoring
• Study Close Out
• Key Issues
• Site Management
• Study Documents
• Process Flow
• Thank you