Clinical Study Report
Clinical Study Report
[Study Title]
[Study number]
[Dd month yyyy]
CONFIDENTIAL
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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:
2 SYNOPSIS
NAME OF SPONSORNAME 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 inclusion
Test product, dose and mode of administration
Duration of treatment
Criteria for evaluation / Primary:
Secondary:
Statistical methods
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:
3 TABLE OF CONTENTS
1TITLE PAGE......
2SYNOPSIS......
3TABLE OF CONTENTS......
4LIST OF ABBREVIATIONS & DEFINITION OF TERMS......
5ETHICS AND REGULATORY APPROVAL......
5.1INDEPENDENT ETHICS COMMITTEE APPROVAL......
5.2ETHICAL CONDUCT OF THE STUDY......
5.3PATIENT INFORMATION AND CONSENT......
5.4REGULATORY APPROVAL......
6INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE......
7INTRODUCTION......
7.1[THERAPEUTIC AREA]
7.2RATIONALE FOR THE STUDY......
8STUDY OBJECTIVES......
9INVESTIGATIONAL PLAN......
9.1OVERALL STUDY DESIGN AND PLAN......
9.1.1STUDY TIMING......
9.1.2STUDY LOCATION......
9.2DISCUSSION OF STUDY DESIGN......
9.3SELECTION OF STUDY POPULATION......
9.3.1INCLUSION CRITERIA......
9.3.2EXCLUSION CRITERIA......
9.3.3WITHDRAWAL OF PATIENTS FROM THERAPY OR ASSESSMENT......
9.4TREATMENTS......
9.4.1TREATMENTS ADMINISTERED......
9.4.2DESCRIPTION OF INVESTIGATIONAL PRODUCTS......
9.4.2.1[Prime]......
9.4.2.2[Boost]......
9.4.3METHOD OF ASSIGNING PATIENTS TO TREATMENT GROUPS......
9.4.4SELECTION OF DOSES IN THE STUDY......
9.4.5SELECTION AND TIMING OF DOSE FOR INDIVIDUAL PATIENTS......
9.4.6PRIOR AND CONCOMITANT THERAPY......
9.4.7TREATMENT COMPLIANCE......
9.5EFFICACY AND SAFETY VARIABLES......
9.5.1EFFICACY AND SAFETY MEASUREMENTS ASSESSED......
9.5.2APPROPRIATENESS OF MEASUREMENTS......
9.5.3IMMUNOGENICITY VARIABLES......
9.6DATA QUALITY ASSURANCE......
9.7STATISTICAL METHODS PLANNED IN THE PROTOCOL & DETERMINATION OF SAMPLE SIZE
9.7.1STATISTICAL AND ANALYTICAL PLANS......
9.7.2DETERMINATION OF SAMPLE SIZE......
9.8CHANGES IN THE CONDUCT OF THE STUDY OR PLANNED ANALYSES......
9.8.1PROTOCOL AMENDMENTS......
10STUDY POPULATION......
10.1DISPOSITION OF PATIENTS......
10.2PROTOCOL DEVIATIONS......
11RESULTS......
11.1DATA SETS ANALYSED......
11.2DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS......
11.3MEASUREMENTS OF TREATMENT COMPLIANCE......
11.4STUDY DURATION......
11.5IMMUNOGENECITY RESULTS AND TABULATIONS OF PATIENT DATA......
11.5.1ANALYSIS OF IMMUNOGENECITY......
11.5.2STATISTICAL/ANALYTICAL ISSUES......
11.5.2.1HANDLING OF DROPOUTS OR MISSING DATA......
11.5.3TABULATION OF INDIVIDUAL RESPONSE DATA......
11.5.4VACCINE DOSE AND RELATIONSHIP TO RESPONSE......
11.5.5BY-PATIENT DISPLAYS......
11.5.6IMMUNOGENECITY CONCLUSIONS......
12SAFETY EVALUATION......
12.1EXTENT OF EXPOSURE......
12.2ADVERSE EVENTS (AE’s)......
12.2.1BRIEF SUMMARY OF ADVERSE EVENTS......
12.2.2TREATMENT EMERGENT ADVERSE EVENTS......
12.2.3TREATMENT RELATED ADVERSE EVENTS......
12.2.4IMMUNISATION TOLERANCE......
12.3SERIOUS ADVERSE EVENTS AND OTHER SIGNIFICANT ADVERSE EVENTS......
12.4DEATHS......
12.5CLINICAL LABORATORY EVALUATION......
12.5.1EVALUATION OF EACH LABORATORY PARAMETER......
12.6VITAL SIGNS, PHYSICAL FINDINGS AND OTHER OBSERVATIONS RELATED TO SAFETY
12.7CONCOMITTANT MEDICATION USE......
12.8SAFETY CONCLUSIONS......
13DISCUSSION AND OVERALL CONCLUSIONS......
14TABLES, FIGURES AND GRAPHS......
15REFERENCES......
16APPENDICES......
4 LIST OF ABBREVIATIONS & DEFINITION OF TERMS
5 ETHICS AND REGULATORY APPROVAL
5.1 INDEPENDENT ETHICS COMMITTEE APPROVAL
The 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 numberInvestigator
Ethics committee
Chairman
Date of approval of the final protocol
Date of approval of amendment 1
Date of approval of amendment 2
Date of approval of amendment 3
5.2 ETHICAL CONDUCT OF THE STUDY
The 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 CONSENT
All 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]
5.4 REGULATORY APPROVAL
The 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 Investigator
Principal investigator
Sponsor
Sponsor
Project Managers
Project Leaders
Clinical Research Associate(s)
Medical Adviser
Laboratory investigator
Data Management
7 INTRODUCTION
7.1 [THERAPEUTIC AREA]
7.2 RATIONALE FOR THE STUDY
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 LOCATION
This 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 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 COMPLIANCE
All 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
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 dayClinical Study Report Template Page 1 of 22
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
10 STUDY POPULATION
10.1 DISPOSITION OF PATIENTS
Table IVDisposition of patients
Group A(N=) / Group B
(N=) / Total
(N=)
Enrolled
Received at least one injection
Received all [x] injections and attended [vist]
Completed [visit]
Withdrawn:
Lost to follow up
Adverse event
Death
Other
Source Data: Listing xx:
10.2 PROTOCOL DEVIATIONS
Table V gives details of study protocol deviations.
Table V Protocol deviations
Deviation / Site: / Site:Entry criteria / 0 / 0
Withdrawal criteria / 0 / 0
Incorrect dosing regimen / 0 / 0
Concomitant treatment/medication / 0 / 0
Other / 0 / 0
Full details of the protocol deviations can be found in appendix 16.2.2
11 RESULTS
11.1 DATA SETS ANALYSED
11.2 DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS
Table XXDemographics of the Study Patients
Group A(N=) / Group B
(N=)
Gender / Male
Female
Age (years) / n
Mean
Min
Max
Height (m) / n
Mean
Min
Max
Weight (kg) / n
Mean
Min
Max
BMI (kg/m2) / n
Mean
Min
Max
See appendix XX for by-patient tabular listings of demographic details.
11.3 MEASUREMENTS OF TREATMENT COMPLIANCE
11.4 STUDY DURATION
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 DATA
How 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
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
16.1STUDY INFORMATION
16.1.1Protocol and Protocol Amendments
16.1.2Case Report Form
16.1.3Ethics Committees and Subject Information
16.1.4Regulatory Approval
16.1.5Investigators and Study Personnel
16.1.6Sponsor and Investigator Signatures
16.1.7Randomisation Code
16.1.8Study Drugs
16.1.9Audit Certificate
16.1.10Statistical Analysis Plan
16.1.11Laboratory quality assurance
16.1.12Publications based on the study
16.1.13Publications referenced in the report
16.2PATIENT DATA LISTINGS
16.3 CASE REPORT FORMS
16.3.1 CRFs for deaths, other serious adverse events and withdrawals for AE
16.3.2 Other CRFs submitted
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