© 2004 1 clinical research practice clinical research organization and management 1

© © 20042004 11

Clinical Research PracticeClinical Research Practice

Clinical Research Organization Clinical Research Organization

and Management 1and Management 1

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ObjectivesObjectives

Describe the life cycle of clinical research.Describe the life cycle of clinical research. Differentiate between clinical research and Differentiate between clinical research and

other types of research.other types of research. Outline how a clinical research team is Outline how a clinical research team is

organized.organized. State the roles and responsibilities of:State the roles and responsibilities of:

SponsorSponsor Principal InvestigatorPrincipal Investigator Institutional Review Board (IRB) orInstitutional Review Board (IRB) or

Institutional Ethics Committee (IEC)Institutional Ethics Committee (IEC) Medicines Control Council (MCC)Medicines Control Council (MCC)

MonitorsMonitors AuditorsAuditors SANASSANAS CommunityCommunity

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ObjectivesObjectives

Differentiate between the three Differentiate between the three levels of responsibility on the clinical levels of responsibility on the clinical research team.research team.

Explain how your particular position Explain how your particular position supports the overall goals of a supports the overall goals of a clinical research project that you are clinical research project that you are currently working on.currently working on.

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What Do You Already Know What Do You Already Know About Clinical Research?About Clinical Research?

Research performed primarily on humans.Research performed primarily on humans. Designed to answer specific questions Designed to answer specific questions

related to human disease interventions related to human disease interventions such as diagnosis, prevention, outcomes such as diagnosis, prevention, outcomes and treatments.and treatments.

Performed according to ICH ethical Performed according to ICH ethical guidelines and GCP/GLP.guidelines and GCP/GLP.

And … it is what we are here to do every And … it is what we are here to do every day.day.

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Is All Research Clinical?Is All Research Clinical? No! Not all research deals with disease No! Not all research deals with disease

intervention and may not include human intervention and may not include human participants.participants.

Research may be conducted on animals.Research may be conducted on animals. Research may not be focused on an Research may not be focused on an

intervention, but rather look for existence intervention, but rather look for existence of disease.of disease.

Can you think of any studies you have Can you think of any studies you have worked on that are NOT clinical research?worked on that are NOT clinical research?

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You Know It Is Clinical Research You Know It Is Clinical Research If…If…

It encompass at least one of the It encompass at least one of the following categories: following categories: Human participationHuman participation Record based studiesRecord based studies Clinical samplesClinical samples Technology development for clinical useTechnology development for clinical use

(according to the Medical Research Council of South Africa guidelines, (according to the Medical Research Council of South Africa guidelines, 2004)2004)

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Define Research Define Research Question Question (What do you want to know?)(What do you want to know?)

The Life Cycle Of The Life Cycle Of A Clinical Research ProjectA Clinical Research Project

Write a Write a ResearcResearchhProposalProposalFind Funding & Find Funding &

Select Research Select Research TeamTeam

Write Write ProtocolProtocol

Conduct Conduct ResearcResearc

hh

Analyse Analyse ResultsResults

Report Report ResultsResults

Get RegulatoryGet Regulatory

ApprovalApproval

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Clinical Research Clinical Research ComponentsComponents

SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity

Principal InvestigatorPrincipal Investigator

& &

Research Team Research Team

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SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity


& &


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SponsorSponsor

Responsible for:Responsible for: trial initiationtrial initiation oversight of the studyoversight of the study financing all activitiesfinancing all activities

The sponsor is the organization that The sponsor is the organization that supports the clinical trial and ensures it supports the clinical trial and ensures it will occur.will occur.

1111 1111


SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity


& &

Research TeamResearch Team

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Principal Investigator & Research Principal Investigator & Research TeamTeam

The Principal Investigator (PI) runs the The Principal Investigator (PI) runs the clinical trial at the trial site. The PI may clinical trial at the trial site. The PI may designate a research team to carry out designate a research team to carry out these duties. these duties. Responsible for:Responsible for:

Compliance to GCP and ICH guidelines. Compliance to GCP and ICH guidelines. Ensures adequate resources and qualified Ensures adequate resources and qualified

team trained on protocol is in place.team trained on protocol is in place. Medical care of trial participants.Medical care of trial participants. Accountable for investigational products.Accountable for investigational products. Produce safety reports and other Produce safety reports and other

documentation.documentation.

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Research Team & Site Research Team & Site OrganizationOrganization

Designing and Designing and implementing a clinical trial implementing a clinical trial requires the many talents requires the many talents of a multidisciplinary of a multidisciplinary research team. research team.

Each team may be set Each team may be set up differently, up differently, depending on an depending on an institution's policy and institution's policy and resources. resources.

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Organization of RCT StudyOrganization of RCT Study

RegulatorRegulatory Officery Officer

ChiefChief Medical OfficerMedical Officer


DataDataManagManag

erer

Clinical Clinical OperationsOperationsManagerManager

AdministrativAdministrative Managere Manager

LaboratorLaboratoryy

ManagerManager

DataDataCapturCaptur

erer

Nurse Nurse CoordinatCoordinat

ororResearch Research NursesNurses

Community Community Health Health

WorkersWorkers

ResearchResearchAssistantsAssistants

MedicalMedicalTechnologistsTechnologists

ScientificScientificOfficersOfficers

Admin.Admin.OfficerOfficer

SupportSupportStaffStaff

InternalInternalMonitorMonitor

How Do How Do YouYou Contribute ContributeTo The Study Goals?To The Study Goals?

Enroll & Enroll & Consent Consent ParticipantsParticipants

Gather Gather Information Information (conduct tests and (conduct tests and collect specimens)collect specimens)

Test Test SpecimensSpecimens

Record Record Participant Participant DataData

Compile Compile & Analyse & Analyse

DataData

Study Study ResultsResults

Monitor Activities and Ensure ComplianceMonitor Activities and Ensure Compliance

Prepare Prepare SiteSite

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Who is the Clinical Research Who is the Clinical Research Team?Team?

Three classifications within Clinical Three classifications within Clinical Research Practice have been proposed:Research Practice have been proposed:

Clinical Research Manager Clinical Research Manager e.g.e.g. Operations Manager. Operations Manager.

Clinical Research Officer Clinical Research Officer e.g.e.g. Nurse Co- Nurse Co-ordinator.ordinator.

Clinical Research Assistant Clinical Research Assistant e.g.e.g. Research Research Nurse Assistant.Nurse Assistant.

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Provide overall management of study activities and Provide overall management of study activities and primary supervision of staff.primary supervision of staff.

Implement and maintain trial systems toward the Implement and maintain trial systems toward the achievement of the clinical trial goals.achievement of the clinical trial goals.

Collate and report study data.Collate and report study data. Manage and consult on budget issues.Manage and consult on budget issues. Provide leadership in setting and achieving long-term Provide leadership in setting and achieving long-term

goals and objectives.goals and objectives. Coordinate activities between clinical, laboratory, data Coordinate activities between clinical, laboratory, data

management and other aspects of the clinical trial.management and other aspects of the clinical trial.

Clinical Research ManagerClinical Research Manager

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Clinical Research OfficerClinical Research Officer

Supervise specific clinical/technical functions Supervise specific clinical/technical functions within clinical research.within clinical research.

Responsible for the confirmation of the Responsible for the confirmation of the integrity of the clinical and demographic integrity of the clinical and demographic data.data.

Monitor the proper and efficient utilization of Monitor the proper and efficient utilization of study materials.study materials.

Oversee the clinical research outcomes. Oversee the clinical research outcomes. Have roles related to the clinical, laboratory Have roles related to the clinical, laboratory

or data management arms of clinical or data management arms of clinical research. research.

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Clinical Research Assistant:Clinical Research Assistant:

Assist in the performance of clinical, Assist in the performance of clinical, laboratory, data management and other laboratory, data management and other aspects of clinical research.aspects of clinical research.

Have roles related to the clinical, Have roles related to the clinical, laboratory or data management arms of laboratory or data management arms of clinical research. clinical research.

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SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity


& &


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Institutional Review Board (IRB) or Institutional Review Board (IRB) or Institutional Ethics Committee Institutional Ethics Committee

(IEC)(IEC)An independent body of medical, An independent body of medical, scientific and non-scientific scientific and non-scientific members that ensures the members that ensures the protection of the rights, safety protection of the rights, safety and well-being of human subjects and well-being of human subjects involved in a trial.involved in a trial.

Responsible for:Responsible for: Review of trial protocol and Review of trial protocol and

recruitment, consent information, etcrecruitment, consent information, etc Retain documents for regulatory Retain documents for regulatory

authority.authority.

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SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity


& &


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Medicines Control Council Medicines Control Council (MCC)(MCC)

MCC is South Africa’s MCC is South Africa’s government authority government authority to to oversee the regulation of oversee the regulation of medicines to ensure the medicines to ensure the safety, quality and efficacy of safety, quality and efficacy of available drugs.available drugs.Responsible for:Responsible for:

Reviewing proposed clinical Reviewing proposed clinical trials in South Africa.trials in South Africa.

Approving clinical trials that Approving clinical trials that meet regulations.meet regulations.

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SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity


& &


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MonitorsMonitors

Monitors are internal and external people Monitors are internal and external people appointed by the sponsor to verify that appointed by the sponsor to verify that the trial is conducted appropriately.the trial is conducted appropriately.

Responsible for:Responsible for: Examining protocol, SOP’s, and Examining protocol, SOP’s, and

other documentation.other documentation. Reviewing documentation and Reviewing documentation and

conduct of trial for compliance to conduct of trial for compliance to GCP and other regulations.GCP and other regulations.

Verify that data is accurate and Verify that data is accurate and participant rights and well-being are participant rights and well-being are protected.protected.

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SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity


& &


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AuditorsAuditorsThe auditors are independent The auditors are independent individuals appointed by the individuals appointed by the Sponsor to conduct a Sponsor to conduct a systematic and in-depth systematic and in-depth examination of trial conduct examination of trial conduct and compliance.and compliance.

Auditors are separate from Auditors are separate from monitors and quality control.monitors and quality control.

Responsible for:Responsible for: Reviewing activities and Reviewing activities and

documentation to check that documentation to check that the protocol, SOPs, GCP, GLP the protocol, SOPs, GCP, GLP and applicable regulatory and applicable regulatory requirements are followed.requirements are followed.

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Why Is Auditing Important?Why Is Auditing Important?

An audit is an examination of data, An audit is an examination of data, records, and written procedures to records, and written procedures to determine accuracy and completeness of determine accuracy and completeness of the research process and maintenance of the research process and maintenance of current regulatory documentation. current regulatory documentation.

The audit provides information to the site The audit provides information to the site staff and Sponsor that verifies the staff and Sponsor that verifies the accuracy and reliability of clinical trials accuracy and reliability of clinical trials data and results. data and results.

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SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity


& &


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SANASSANAS

The South African National The South African National Accreditation System Accreditation System (SANAS) is the body that (SANAS) is the body that gives formal recognition gives formal recognition that test facilities are that test facilities are competent to carry out competent to carry out specific tasks. specific tasks.

Responsible for:Responsible for: Inspecting facilities to Inspecting facilities to

ensure compliance to ensure compliance to OECD GLP principles. OECD GLP principles.

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SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity


& &


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CommunityCommunity

The community where clinical research The community where clinical research is performed is involved through a is performed is involved through a Community Advisory Board that takes Community Advisory Board that takes an active role in research activities an active role in research activities and is kept up-to-date on study and is kept up-to-date on study activities.activities.Responsible for:Responsible for:

Providing insight into the needs of Providing insight into the needs of the community.the community.

Promoting community awareness Promoting community awareness of the study.of the study.

Playing an active role in Playing an active role in safeguarding the community safeguarding the community rights.rights.

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ReviewReview

Clinical research is a process that Clinical research is a process that seeks to find the answer to a seeks to find the answer to a question about a health intervention.question about a health intervention.

Clinical research is performed Clinical research is performed primarily on humans with the hope of primarily on humans with the hope of resulting in new or improved health resulting in new or improved health interventions.interventions.

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ReviewReview

Clinical Research is organized with a Clinical Research is organized with a variety of oversight committees and variety of oversight committees and regulatory bodies to ensure respect and regulatory bodies to ensure respect and safety for human participants, including:safety for human participants, including:

SponsorSponsor Principal InvestigatorPrincipal Investigator IRB/IECIRB/IEC CommunityCommunity

Medicines Control Medicines Control Council (MCC)Council (MCC)

SANASSANAS MonitorsMonitors AuditorsAuditors

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SponsorSponsor

SANASSANAS

AuditorsAuditors

IRB/IECIRB/IEC

MCCMCC

MonitorsMonitors

CommunityCommunity


& &


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ReviewReview

Each clinical research site has Each clinical research site has common jobs and responsibilities, common jobs and responsibilities, but may be organized differently.but may be organized differently.

The organization of clinical research The organization of clinical research at UCT is unique to UCT.at UCT is unique to UCT.

EveryoneEveryone on the team contributes to on the team contributes to the goals and ultimate success of the the goals and ultimate success of the clinical research.clinical research.

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This presentation is produced by Aeras Global TB Vaccine FoundationSM in collaboration with the University of Cape Town and the South African Tuberculosis Vaccine Initiative.

A special thanks to Professor Greg Hussey, Deon Minnies, Lucrecia Michaels, Marie Buchanan, Marijke Geldenhuys, MSHS CRA, Marwou De Kock, B.Tec., Dr. Sylvia Silver, D.A., and Jen Page, M.Ed. for their contributions and support for this presentation.

Clinical Research Organization Clinical Research Organization and Management 1and Management 1

© 2004 1 clinical research practice clinical research organization and management 1

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