154679434 clinical-study-report-template-ght
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Clinical Study Report
[Study Title]
[Study number]
[Dd month yyyy]
CONFIDENTIAL
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Signature pages for clinical study report
I have read this report and confirm that to the best of my knowledge it accurately describes the conduct and results of the study.
Signed: Date: ____/____/______
Print name:
Affiliation:
Address:
Signed: Date: ____/____/______
Print name:
Affiliation:
Address:
Signed: Date: ____/____/______
Print name:
Affiliation:
Address:
Signed: Date: ____/____/______
Print name:
Affiliation:
Address:
Signed: Date: ____/____/______
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Affiliation:
Address:
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1 TITLE PAGE
Study title:
Name of Test Drug:
Indication studied:
Study description:
Sponsors:
Protocol:
Clinical Phase:
Study dates:
Investigators:
Medical Officer:
Sponsor signatory:
GCP Statement: This study was performed in compliance with ICH Good Clinical Practise (GCP) including the archiving of essential documents
Date of report:
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2 SYNOPSISNAME OF SPONSOR
NAME OF FINISHED PRODUCT N/A
NAME OF ACTIVE INGREDIENT(S)
INDIVIDUAL STUDY TABLE REFERRING TO MODULE 5 OF THE CTD
Volume:
Page:
(FOR NATIONAL AUTHORITY USE ONLY)
Title of Study
Investigator(s)
Study centre(s)
Publication N/A
Study period From: To:
Phase of development Phase
Objectives Primary Objective
Secondary Objective
Methodology
Number of patients
Planned:
Analysed:
Diagnosis and main criteria for inclusionTest product, dose and mode of administrationDuration of treatmentCriteria for evaluation
Primary: Secondary:
Statistical methods
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NAME OF COMPANY
NAME OF FINISHED PRODUCT N/A
NAME OF ACTIVE INGREDIENT(S)
INDIVIDUAL STUDY TABLE REFERRING TO MODULE 5 OF THE CTD
Volume:
Page:
(FOR NATIONAL AUTHORITY USE ONLY)
SUMMARY CONCLUSIONS
EFFICACY RESULTS
SAFETY RESULTS
CONCLUSION
DATE OF THE REPORT:
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3 TABLE OF CONTENTS
1 TITLE PAGE.............................................................................................................................. 32 SYNOPSIS................................................................................................................................ 43 TABLE OF CONTENTS............................................................................................................64 LIST OF ABBREVIATIONS & DEFINITION OF TERMS..........................................................85 ETHICS AND REGULATORY APPROVAL..............................................................................95.1 INDEPENDENT ETHICS COMMITTEE APPROVAL...........................................................9
5.2 ETHICAL CONDUCT OF THE STUDY.................................................................................9
5.3 PATIENT INFORMATION AND CONSENT..........................................................................9
5.4 REGULATORY APPROVAL...............................................................................................10
6 INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE.......................................107 INTRODUCTION..................................................................................................................... 117.1 [THERAPEUTIC AREA]......................................................................................................11
7.2 RATIONALE FOR THE STUDY..........................................................................................11
8 STUDY OBJECTIVES.............................................................................................................129 INVESTIGATIONAL PLAN.....................................................................................................129.1 OVERALL STUDY DESIGN AND PLAN.............................................................................129.1.1 STUDY TIMING.............................................................................................................129.1.2 STUDY LOCATION.......................................................................................................12
9.2 DISCUSSION OF STUDY DESIGN....................................................................................12
9.3 SELECTION OF STUDY POPULATION............................................................................129.3.1 INCLUSION CRITERIA.................................................................................................129.3.2 EXCLUSION CRITERIA................................................................................................129.3.3 WITHDRAWAL OF PATIENTS FROM THERAPY OR ASSESSMENT.........................12
9.4 TREATMENTS.................................................................................................................... 139.4.1 TREATMENTS ADMINISTERED..................................................................................139.4.2 DESCRIPTION OF INVESTIGATIONAL PRODUCTS..................................................139.4.2.1 [PRIME].........................................................................................................................................139.4.2.2 [BOOST]........................................................................................................................................139.4.3 METHOD OF ASSIGNING PATIENTS TO TREATMENT GROUPS.............................139.4.4 SELECTION OF DOSES IN THE STUDY.....................................................................139.4.5 SELECTION AND TIMING OF DOSE FOR INDIVIDUAL PATIENTS...........................139.4.6 PRIOR AND CONCOMITANT THERAPY.....................................................................139.4.7 TREATMENT COMPLIANCE........................................................................................13
9.5 EFFICACY AND SAFETY VARIABLES..............................................................................139.5.1 EFFICACY AND SAFETY MEASUREMENTS ASSESSED..........................................139.5.2 APPROPRIATENESS OF MEASUREMENTS..............................................................169.5.3 IMMUNOGENICITY VARIABLES..................................................................................16
9.6 DATA QUALITY ASSURANCE...........................................................................................16
9.7 STATISTICAL METHODS PLANNED IN THE PROTOCOL & DETERMINATION OF SAMPLE SIZE.............................................................................................................................. 16
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9.7.1 STATISTICAL AND ANALYTICAL PLANS....................................................................169.7.2 DETERMINATION OF SAMPLE SIZE...........................................................................16
9.8 CHANGES IN THE CONDUCT OF THE STUDY OR PLANNED ANALYSES...................169.8.1 PROTOCOL AMENDMENTS........................................................................................16
10 STUDY POPULATION............................................................................................................1610.1 DISPOSITION OF PATIENTS............................................................................................16
10.2 PROTOCOL DEVIATIONS.................................................................................................18
11 RESULTS................................................................................................................................ 1911.1 DATA SETS ANALYSED....................................................................................................19
11.2 DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS......................................19
11.3 MEASUREMENTS OF TREATMENT COMPLIANCE........................................................19
11.4 STUDY DURATION............................................................................................................19
11.5 IMMUNOGENECITY RESULTS AND TABULATIONS OF PATIENT DATA......................2011.5.1 ANALYSIS OF IMMUNOGENECITY.............................................................................2011.5.2 STATISTICAL/ANALYTICAL ISSUES...........................................................................2011.5.2.1 HANDLING OF DROPOUTS OR MISSING DATA......................................................................2011.5.3 TABULATION OF INDIVIDUAL RESPONSE DATA......................................................2011.5.4 VACCINE DOSE AND RELATIONSHIP TO RESPONSE.............................................2011.5.5 BY-PATIENT DISPLAYS...............................................................................................2011.5.6 IMMUNOGENECITY CONCLUSIONS..........................................................................20
12 SAFETY EVALUATION..........................................................................................................2112.1 EXTENT OF EXPOSURE...................................................................................................21
12.2 ADVERSE EVENTS (AE’s).................................................................................................2112.2.1 BRIEF SUMMARY OF ADVERSE EVENTS.................................................................2112.2.2 TREATMENT EMERGENT ADVERSE EVENTS..........................................................2112.2.3 TREATMENT RELATED ADVERSE EVENTS..............................................................2112.2.4 IMMUNISATION TOLERANCE.....................................................................................21
12.3 SERIOUS ADVERSE EVENTS AND OTHER SIGNIFICANT ADVERSE EVENTS...........22
12.4 DEATHS............................................................................................................................. 22
12.5 CLINICAL LABORATORY EVALUATION...........................................................................2212.5.1 EVALUATION OF EACH LABORATORY PARAMETER..............................................22
12.6 VITAL SIGNS, PHYSICAL FINDINGS AND OTHER OBSERVATIONS RELATED TO SAFETY 22
12.7 CONCOMITTANT MEDICATION USE...............................................................................22
12.8 SAFETY CONCLUSIONS...................................................................................................22
13 DISCUSSION AND OVERALL CONCLUSIONS....................................................................2214 TABLES, FIGURES AND GRAPHS.......................................................................................2315 REFERENCES........................................................................................................................ 2416 APPENDICES.......................................................................................................................... 25
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4 LIST OF ABBREVIATIONS & DEFINITION OF TERMS
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5 ETHICS AND REGULATORY APPROVAL
5.1 INDEPENDENT ETHICS COMMITTEE APPROVALThe study protocol and all its amendments, and the patient information sheet(s) were reviewed and approved by the appropriate independent ethics committees as detailed in table one below.
Table I: Ethics committees
Centre name and number
Investigator
Ethics committee
Chairman
Date of approval of the final protocol Date of approval of amendment 1Date of approval of amendment 2Date of approval of amendment 3
5.2 ETHICAL CONDUCT OF THE STUDYThe study was performed in accordance with the current version of the declaration of Helsinki (52nd WMA General Assembly, Edinburgh, Scotland, October 2000). The trial was conducted in agreement with the International Conference on Harmonisation (ICH) guidelines on Good Clinical Practise (GCP)
5.3 PATIENT INFORMATION AND CONSENTAll patients provided written informed consent to participate in the study prior to being screened.
The patient information sheet detailed the procedures involved in the study (aims, methodology. potential risks, anticipated benefits) and the investigator explained these to each patient. The patient signed the consent form to indicate that the information had been explained and understood. The patient was then allowed time to consider the information presented before signing and dating the informed consent form to indicate that they fully understood the information, and willingly volunteered to participate in the study. The patient was given a copy of the informed consent form for their information. The original copy of the informed consent was kept in a confidential file in the Investigators centre records. A sample of the patient information sheet and consent form can be found at appendix [insert]
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5.4 REGULATORY APPROVALThe study was performed in compliance with the requirements of the [regulatory authorities]. The study gained full regulatory approval from the on [date], SPONSOR was issued with the following EudraCT number [ ]. A copy can be found in appendix [insert]
The study gained full approval from [EC] on [insert] a copy can be found in appendix [insert]
6 INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
Table II shows the principal study personnel involved in the study.
Table II: Principal study personnel
Title Name and affiliationPrincipal InvestigatorPrincipal investigatorSponsor
Sponsor
Project ManagersProject LeadersClinical Research Associate(s)Medical AdviserLaboratory investigatorData Management
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7 INTRODUCTION
7.1 [THERAPEUTIC AREA]
7.2 RATIONALE FOR THE STUDY
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8 STUDY OBJECTIVES
Primary Objective
Secondary Objective
9 INVESTIGATIONAL PLAN
9.1 OVERALL STUDY DESIGN AND PLAN
9.1.1 STUDY TIMING
Figure I Schematic chart of Protocol
9.1.2 STUDY LOCATIONThis study was conducted at the following locations:
9.2 DISCUSSION OF STUDY DESIGN
9.3 SELECTION OF STUDY POPULATION
9.3.1 INCLUSION CRITERIA
9.3.2 EXCLUSION CRITERIA
9.3.3 WITHDRAWAL OF PATIENTS FROM THERAPY OR ASSESSMENT
Patients were free to withdraw from the study at any time without giving a reason. Patients were advised that if they requested to withdraw from the study, at any time during the trial, then this would have no negative consequences.
The investigator could also withdraw patients from the trial if they deemed it appropriate for safety or ethical reasons or if it was considered to be to be detrimental to the well-being of the patient. Patients who withdrew or were withdrawn underwent a final
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evaluation at [visit]. Patients who did not complete the study through to [visit], unless removed due to toxicity, could have been replaced
Full documentation was made of any withdrawals that occurred during the study in the CRF. The Investigator documented the date and time of the withdrawal and results of any assessments made at this time. If the patient withdrew because of an adverse event (AE) or a serious adverse event (SAE) then details were forwarded to the Ethics committee as required. The investigator also forwarded details to SPONSOR. SPONSOR forwarded details to the regulatory authorities as appropriate.
9.4 TREATMENTS
9.4.1 TREATMENTS ADMINISTERED
9.4.2 DESCRIPTION OF INVESTIGATIONAL PRODUCTS
9.4.3 METHOD OF ASSIGNING PATIENTS TO TREATMENT GROUPS
9.4.4 SELECTION OF DOSES IN THE STUDY
9.4.5 SELECTION AND TIMING OF DOSE FOR INDIVIDUAL PATIENTS
9.4.6 PRIOR AND CONCOMITANT THERAPY
9.4.7 TREATMENT COMPLIANCEAll study treatment was administered by the study investigator or designated member of staff. To ensure drug accountability the investigator or designated deputy maintained accurate records of the dates and amounts of drug received, to whom it was dispensed and accounts of any supplies which were accidentally or deliberately destroyed; these details were recorded on a drug accountability form. All unused clinical supplies and the drug accountability forms were returned to SPONSOR at the end of the study.
9.5 EFFICACY AND SAFETY VARIABLES
9.5.1 EFFICACY AND SAFETY MEASUREMENTS ASSESSED
Performance status
CT Scan (Disease status)
ECG
Clinical Assessment of Injection Site
Clinical Examination
Vital Signs
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Safety
Laboratory Tests
Haematology
Serum chemistry
Urinalysis
HBV, HCV, HIV and pregnancy
Cellular immunology
Table III shows the schedule of examinations and procedures.
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Table III [Schedule of examinations and procedures]
Study day
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9.5.2 APPROPRIATENESS OF MEASUREMENTS
9.5.3 IMMUNOGENICITY VARIABLES
9.6 DATA QUALITY ASSURANCE
9.7 STATISTICAL METHODS PLANNED IN THE PROTOCOL & DETERMINATION OF SAMPLE SIZE
9.7.1 STATISTICAL AND ANALYTICAL PLANS
9.7.2 DETERMINATION OF SAMPLE SIZE
9.8 CHANGES IN THE CONDUCT OF THE STUDY OR PLANNED ANALYSES
9.8.1 PROTOCOL AMENDMENTS
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10 STUDY POPULATION
10.1 DISPOSITION OF PATIENTS
Table IV Disposition of patients
Group A (N=)
Group B(N=)
Total(N=)
EnrolledReceived at least one injectionReceived all [x] injections and attended [vist]Completed [visit]Withdrawn:
Lost to follow upAdverse event
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PATIENTS SCREENED N=
PATIENTS RANDOMISED N=
SCREENING FAILURES N=
GROUP A N=
GROUP B N=
COMPLETED N= WITHDRAWN N= WITHDRAWN
N=COMPLETED
N=
LOST TO FOLLOW UP (0)ADVERSE EVENT (0)DEATH (0 )OTHER ( )
RECEIVED [Prime] RECEIVED [Prime] RECEIVED [Boost] RECEIVED [Boost] ATTENDED [visit] COMPLETED [Visit]
RECEIVED [Prime] RECEIVED [Prime] RECEIVED [Boost] RECEIVED [Boost] ATTENDED [visit] COMPLETED [Visit]
DeathOther
Source Data: Listing xx:
10.2 PROTOCOL DEVIATIONSTable V gives details of study protocol deviations.
Table V Protocol deviations
Deviation Site: Site: Entry criteria 0 0Withdrawal criteria 0 0Incorrect dosing regimen 0 0Concomitant treatment/medication
0 0
Other 0 0
Full details of the protocol deviations can be found in appendix 16.2.2
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11 RESULTS
11.1 DATA SETS ANALYSED
11.2 DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS
Table XX Demographics of the Study Patients
Group A(N=)
Group B(N=)
Gender MaleFemale
Age (years) nMeanMinMax
Height (m) nMeanMinMax
Weight (kg) nMeanMinMax
BMI (kg/m2) nMeanMinMax
See appendix XX for by-patient tabular listings of demographic details.
11.3 MEASUREMENTS OF TREATMENT COMPLIANCE
11.4 STUDY DURATION
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11.5 IMMUNOGENECITY RESULTS AND TABULATIONS OF PATIENT DATA
11.5.1 ANALYSIS OF IMMUNOGENECITY
11.5.2 STATISTICAL/ANALYTICAL ISSUES
11.5.2.1 HANDLING OF DROPOUTS OR MISSING DATAHow if any dropouts were handled- why they dropped out, how long they were in the study for. Analysis of a pattern for patient drop out rates, determining factor, common variant. Missing data, incomplete CRF’s, how this is handled, and why this took place.
11.5.3 TABULATION OF INDIVIDUAL RESPONSE DATA
11.5.4 VACCINE DOSE AND RELATIONSHIP TO RESPONSE
11.5.5 BY-PATIENT DISPLAYS
11.5.6 IMMUNOGENECITY CONCLUSIONS
12 SAFETY EVALUATION
12.1 EXTENT OF EXPOSURE
12.2 ADVERSE EVENTS (AE’s)
12.2.1 BRIEF SUMMARY OF ADVERSE EVENTS
12.2.2 TREATMENT EMERGENT ADVERSE EVENTS
12.2.3 TREATMENT RELATED ADVERSE EVENTS
12.2.4 IMMUNISATION TOLERANCE
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12.3 SERIOUS ADVERSE EVENTS AND OTHER SIGNIFICANT ADVERSE EVENTS
12.4 DEATHS
12.5 CLINICAL LABORATORY EVALUATION
12.5.1 EVALUATION OF EACH LABORATORY PARAMETER
12.6 VITAL SIGNS, PHYSICAL FINDINGS AND OTHER OBSERVATIONS RELATED TO SAFETY
12.7 CONCOMITTANT MEDICATION USE
12.8 SAFETY CONCLUSIONS
13 DISCUSSION AND OVERALL CONCLUSIONS
14 TABLES, FIGURES AND GRAPHS
15 REFERENCES
16 APPENDICES
16.1 STUDY INFORMATION16.1.1 Protocol and Protocol Amendments16.1.2 Case Report Form16.1.3 Ethics Committees and Subject Information16.1.4 Regulatory Approval16.1.5 Investigators and Study Personnel16.1.6 Sponsor and Investigator Signatures
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16.1.7 Randomisation Code16.1.8 Study Drugs16.1.9 Audit Certificate16.1.10 Statistical Analysis Plan16.1.11 Laboratory quality assurance16.1.12 Publications based on the study16.1.13 Publications referenced in the report
16.2 PATIENT DATA LISTINGS
16.3 CASE REPORT FORMS16.3.1 CRFs for deaths, other serious adverse events and withdrawals for AE16.3.2 Other CRFs submitted
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