Clinical Study Report

[Study Title]

[Study number]

[Dd month yyyy]

CONFIDENTIAL
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:

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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 SYNOPSIS
NAME OF SPONSOR INDIVIDUAL STUDY TABLE (FOR NATIONAL
REFERRING TO MODULE 5 AUTHORITY USE
NAME OF FINISHED PRODUCT N/A OF THE CTD ONLY)

NAME OF ACTIVE INGREDIENT(S) Volume:

Page:
Title of Study

Investigator(s)

Study centre(s)

Publication N/A

Study period From: Phase of development Phase

To:
Objectives Primary Objective

Secondary Objective

Methodology

Number of Planned:
patients
Analysed:

Diagnosis and
main criteria for
inclusion
Test product, dose
and mode of
administration
Duration of
treatment
Criteria for Primary:
evaluation Secondary:

Statistical methods

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NAME OF COMPANY INDIVIDUAL STUDY TABLE (FOR NATIONAL
REFERRING TO MODULE 5 AUTHORITY USE
NAME OF FINISHED PRODUCT N/A OF THE CTD ONLY)

NAME OF ACTIVE INGREDIENT(S) Volume:

Page:

SUMMARY CONCLUSIONS

EFFICACY RESULTS

SAFETY RESULTS

CONCLUSION

DATE OF THE REPORT:

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3 TABLE OF CONTENTS

1 TITLE PAGE.............................................................................................................................. 3
2 SYNOPSIS................................................................................................................................ 4
3 TABLE OF CONTENTS............................................................................................................ 6
4 LIST OF ABBREVIATIONS & DEFINITION OF TERMS..........................................................8
5 ETHICS AND REGULATORY APPROVAL..............................................................................9
5.1 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.......................................10
7 INTRODUCTION..................................................................................................................... 11
7.1 [THERAPEUTIC AREA]...................................................................................................... 11
7.2 RATIONALE FOR THE STUDY.......................................................................................... 11
8 STUDY OBJECTIVES............................................................................................................. 12
9 INVESTIGATIONAL PLAN..................................................................................................... 12
9.1 OVERALL STUDY DESIGN AND PLAN.............................................................................12
9.1.1 STUDY TIMING............................................................................................................. 12
9.1.2 STUDY LOCATION....................................................................................................... 12
9.2 DISCUSSION OF STUDY DESIGN....................................................................................12
9.3 SELECTION OF STUDY POPULATION............................................................................12
9.3.1 INCLUSION CRITERIA................................................................................................. 12
9.3.2 EXCLUSION CRITERIA................................................................................................ 12
9.3.3 WITHDRAWAL OF PATIENTS FROM THERAPY OR ASSESSMENT.........................12
9.4 TREATMENTS.................................................................................................................... 13
9.4.1 TREATMENTS ADMINISTERED..................................................................................13
9.4.2 DESCRIPTION OF INVESTIGATIONAL PRODUCTS..................................................13
9.4.2.1 [PRIME]......................................................................................................................................... 13
9.4.2.2 [BOOST]........................................................................................................................................ 13
9.4.3 METHOD OF ASSIGNING PATIENTS TO TREATMENT GROUPS.............................13
9.4.4 SELECTION OF DOSES IN THE STUDY.....................................................................13
9.4.5 SELECTION AND TIMING OF DOSE FOR INDIVIDUAL PATIENTS...........................13
9.4.6 PRIOR AND CONCOMITANT THERAPY.....................................................................13
9.4.7 TREATMENT COMPLIANCE........................................................................................ 13
9.5 EFFICACY AND SAFETY VARIABLES..............................................................................13
9.5.1 EFFICACY AND SAFETY MEASUREMENTS ASSESSED..........................................13
9.5.2 APPROPRIATENESS OF MEASUREMENTS..............................................................16
9.5.3 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....................................................................16
9.7.2 DETERMINATION OF SAMPLE SIZE...........................................................................16
9.8 CHANGES IN THE CONDUCT OF THE STUDY OR PLANNED ANALYSES...................16
9.8.1 PROTOCOL AMENDMENTS........................................................................................ 16
10 STUDY POPULATION............................................................................................................ 16
10.1 DISPOSITION OF PATIENTS............................................................................................16
10.2 PROTOCOL DEVIATIONS.................................................................................................18
11 RESULTS................................................................................................................................ 19
11.1 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......................20
11.5.1 ANALYSIS OF IMMUNOGENECITY.............................................................................20
11.5.2 STATISTICAL/ANALYTICAL ISSUES...........................................................................20
11.5.2.1 HANDLING OF DROPOUTS OR MISSING DATA......................................................................20
11.5.3 TABULATION OF INDIVIDUAL RESPONSE DATA......................................................20
11.5.4 VACCINE DOSE AND RELATIONSHIP TO RESPONSE.............................................20
11.5.5 BY-PATIENT DISPLAYS............................................................................................... 20
11.5.6 IMMUNOGENECITY CONCLUSIONS..........................................................................20
12 SAFETY EVALUATION.......................................................................................................... 21
12.1 EXTENT OF EXPOSURE................................................................................................... 21
12.2 ADVERSE EVENTS (AE’s).................................................................................................21
12.2.1 BRIEF SUMMARY OF ADVERSE EVENTS.................................................................21
12.2.2 TREATMENT EMERGENT ADVERSE EVENTS..........................................................21
12.2.3 TREATMENT RELATED ADVERSE EVENTS..............................................................21
12.2.4 IMMUNISATION TOLERANCE.....................................................................................21
12.3 SERIOUS ADVERSE EVENTS AND OTHER SIGNIFICANT ADVERSE EVENTS...........22
12.4 DEATHS............................................................................................................................. 22
12.5 CLINICAL LABORATORY EVALUATION...........................................................................22
12.5.1 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....................................................................22
14 TABLES, FIGURES AND GRAPHS.......................................................................................23
15 REFERENCES........................................................................................................................ 24
16 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 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 number

Investigator

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]

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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 affiliation

Principal
Investigator
Principal
investigator
Sponsor

Sponsor

Project
Managers
Project Leaders
Clinical
Research
Associate(s)
Medical Adviser
Laboratory
investigator
Data
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 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

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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 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

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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

PATIENTS SCREENED
N=

SCREENING FAILURES
N=
PATIENTS RANDOMISED
N=

GROUP A GROUP B
N= N=

COMPLETED COMPLETED WITHDRAWN

WITHDRAWN N=
N= N= N=

LOST TO FOLLOW UP (0)

ADVERSE EVENT (0)
DEATH (0 )
OTHER ( )

RECEIVED [Prime]
RECEIVED [Prime] RECEIVED [Prime]
RECEIVED [Prime] RECEIVED [Boost]
RECEIVED [Boost] RECEIVED [Boost]
RECEIVED [Boost] ATTENDED [visit]
ATTENDED [visit] COMPLETED [Visit]
COMPLETED [Visit]

10.1 DISPOSITION OF PATIENTS

Table IV Disposition of patients

Group A Group B Total

(N=) (N=) (N=)
Enrolled
Received at least one injection
Received all [x] injections and
attended [vist]
Completed [visit]
Withdrawn:
Lost to follow up
Adverse event

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 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 0 0
treatment/medication
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 Group B
(N=) (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

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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 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

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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 INFORMATION

16.1.1 Protocol and Protocol Amendments

16.1.2 Case Report Form

16.1.3 Ethics Committees and Subject Information
16.1.4 Regulatory Approval

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16.1.5 Investigators and Study Personnel
16.1.6 Sponsor and Investigator Signatures
16.1.7 Randomisation Code
16.1.8 Study Drugs
16.1.9 Audit Certificate
16.1.10 Statistical Analysis Plan
16.1.11 Laboratory quality assurance
16.1.12 Publications based on the study
16.1.13 Publications referenced in the report

16.2 PATIENT 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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