Clinical Study Report Template - GHT

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:

____/____/______  

Date:

____/____/______ 

Date:

____/____/______ 

Date:

____/____/______ 

Date:

____/____/______ 

Print name:  Affiliation:  Affiliation:  Address:

Signed: Print name:  Affiliation:  Affiliation:  Address:

Signed: Print name:  Affiliation:  Affiliation:  Address:

Signed: Print name:  Affiliation:  Affiliation:  Address:

Signed: Print name:  Affiliation:  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 NAME OF FINISHED PRODUCT

N/A

NAME OF ACTIVE INGREDIENT(S)

INDIVIDUAL STUDY TABLE REFERRING TO MODULE 5 OF THE CTD

(FOR NATIONAL AUTHORITY USE ONLY)

Volume: Page:

Title of Study Investigator(s) Study centre(s) Publication

N/A

Study period

From: To: Primary Objective

Objectives

Phase of development

Phase

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

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NAME OF COMPANY NAME OF FINISHED PRODUCT NAME OF ACTIVE INGREDIENT(S)

N/A

INDIVIDUAL STUDY TABLE REFERRING TO MODULE 5 OF THE CTD

(FOR NATIONAL AUTHORITY USE ONLY)

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........................................................................................................................1 3 9.4.1 TREATMENTS ADMINISTERED.........................................................................................13 9.4.2 DESCRIPTION OF INVESTIGATIONAL PRODUCTS........................................................ 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 9.7.1 STATISTICAL AND ANALYTICAL PLANS ......................................................................... 16 9.7.2 DETERMINATION OF SAMPLE SIZE.................................................................................16

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9.8 CHANGES IN THE CONDUCT OF THE STUDY OR PLANNED ANALYSES..................... ..16 9.8.1 PROTOCOL AMENDMENTS.............................................................................................. 16 10 STUDY POPULATION............................................................................................................ 17 10.1 DISPOSITION OF PATIENTS.............................................................................................. 17 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......................................................................................................... . 20 12.1 EXTENT OF EXPOSURE .................................................................................................... 20 12.2 ADVERSE EVENTS (AE’s)...................................................................................................20 12.2.1 BRIEF SUMMARY OF ADVERSE EVENTS......................................................................20 12.2.2 TREATMENT EMERGENT ADVERSE EVENTS.............................................................. 20 12.2.3 TREATMENT RELATED ADVERSE EVENTS.................................................................. 20 12.2.4 IMMUNISATION TOLERANCE..........................................................................................20 12.3 SERIOUS ADVERSE EVENTS AND OTHER SIGNIFICANT ADVERSE EVENTS..............21 12.4 DEATHS............................................................................................................................ .. 21 12.5 CLINICAL LABORATORY EVALUATION ............................................................................21 12.5.1 EVALUATION OF EACH LABORATORY PARAMETER ..................................................21 12.6 VITAL SIGNS, PHYSICAL FINDINGS AND OTHER OBSERVATIONS RELATED TO SAFETY 21 12.7 CONCOMITTANT MEDICATION USE................................................................................. 21 12.8 SAFETY CONCLUSIONS..................................................................................................... 21 13 DISCUSSION AND OVERALL CONCLUSIONS................................................................... 21 14 TABLES, FIGURES AND GRAPHS .......................................................................................21 15 REFERENCES........................................................................................................................ 21 16 APPENDICES..................................................................................................................... .... 21

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4

LIST OF ABBREVIATIONS & DEFINITION OF TERMS

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5

ETHICS AND REGULATORY APPROVAL 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

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)

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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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 Principal Investigator  Principal investigator  Sponsor 

Name and affiliation

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

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7

INTRODUCTION [THERAPEUTIC AREA]

RATIONALE FOR THE STUDY

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8

STUDY OBJECTIVES

Primary Objective Secondary Objective

9

INVESTIGATIONAL PLAN 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:

DISCUSSION OF STUDY DESIGN

SELECTION OF STUDY POPULATION 9.3.1

INCLUSION CRITERIA

9.3.2

EXCLUSION CRITERIA

9.3.3

WITHDRAWAL ASSESSMENT

OF

PATIENTS

FROM

THERAPY

OR

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 wellbeing 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.

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. 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 DATA QUALITY ASSURANCE

STATISTICAL METHODS PLANNED IN THE PROTOCOL & DETERMINATION OF SAMPLE SIZE 9.7.1

STATISTICAL AND ANALYTICAL PLANS

9.7.2

DETERMINATION OF SAMPLE SIZE

CHANGES IN THE CONDUCT OF THE STUDY OR PLANNED ANALYSES

9.5.2

APPROPRIATENESS OF MEASUREMENTS

9.5.3

IMMUNOGENICITY VARIABLES DATA QUALITY ASSURANCE

STATISTICAL METHODS PLANNED IN THE PROTOCOL & DETERMINATION OF SAMPLE SIZE 9.7.1

STATISTICAL AND ANALYTICAL PLANS

9.7.2

DETERMINATION OF SAMPLE SIZE

CHANGES IN THE CONDUCT OF THE STUDY OR PLANNED ANALYSES

9.8.1

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PROTOCOL AMENDMENTS

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10 STUDY POPULATION PATIENTS SCREENED N=

SCREENING FAILURES N=

PATIENTS RANDOMISED N=

GROUP A N= COMPLETED N=

GROUP B N=

WITHDRAWN N=

COMPLETED N=

WITHDRAWN 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]

DISPOSITION OF PATIENTS Table IV

Disposition 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

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Death Other  Source Data: Listing xx:

PROTOCOL DEVIATIONS Table V gives details of study protocol deviations. Table V

Protocol deviations

Deviation Entry criteria Withdrawal criteria Incorrect dosing regimen Concomitant treatment/medication Other 

Site:

Site: 0 0 0 0

0 0 0 0

0

0

Full details of the protocol deviations can be found in appendix 16.2.2

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11 RESULTS

DATA SETS ANALYSED DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS Table XX Demographics of the Study Patients

Group A (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

Group B (N=)

See appendix XX for by-patient tabular listings of demographic details.

MEASUREMENTS OF TREATMENT COMPLIANCE

STUDY DURATION

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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 EXTENT OF EXPOSURE

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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SERIOUS ADVERSE EVENTS AND OTHER SIGNIFICANT ADVERSE EVENTS

DEATHS

CLINICAL LABORATORY EVALUATION

12.5.1

EVALUATION OF EACH LABORATORY PARAMETER

VITAL SIGNS, PHYSICAL FINDINGS AND OTHER OBSERVATIONS RELATED TO SAFETY

CONCOMITTANT MEDICATION USE

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

16.1.5

Investigators and Study Personnel

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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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