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[Study Title]
[Study number]
CONFIDENTIAL
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Page 2 of 22
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:
Date of report:
Page 3 of 22
SYNOPSIS
NAME OF SPONSOR
NAME OF FINISHED PRODUCT
N/A
(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
Page 4 of 22
NAME OF COMPANY
NAME OF FINISHED PRODUCT
NAME OF ACTIVE INGREDIENT(S)
N/A
(FOR NATIONAL
AUTHORITY USE
ONLY)
Volume:
Page:
SUMMARY CONCLUSIONS
EFFICACY RESULTS
SAFETY RESULTS
CONCLUSION
Page 5 of 22
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
9.4.3 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
Page 6 of 22
Page 7 of 22
Page 8 of 22
Ethics committees
Page 9 of 22
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
Sponsor
Project
Managers
Project Leaders
Clinical
Research
Associate(s)
Medical Adviser
Laboratory
investigator
Data
Management
Page 10 of 22
INTRODUCTION
7.1
[THERAPEUTIC AREA]
7.2
Page 11 of 22
STUDY OBJECTIVES
Primary Objective
Secondary Objective
9
INVESTIGATIONAL PLAN
9.1
9.1.1
STUDY TIMING
Figure I
9.1.2
STUDY LOCATION
This study was conducted at the following locations:
9.2
9.3
9.3.1
INCLUSION CRITERIA
9.3.2
EXCLUSION CRITERIA
9.3.3
Page 12 of 22
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
9.4.3
9.4.4
9.4.5
9.4.6
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
9.5.1
Performance status
CT Scan (Disease status)
ECG
Clinical Assessment of Injection Site
Clinical Examination
Vital Signs
Page 13 of 22
Safety
Laboratory Tests
Haematology
Serum chemistry
Urinalysis
HBV, HCV, HIV and pregnancy
Cellular immunology
Table III shows the schedule of examinations and procedures.
Page 14 of 22
Table III
Page 15 of 22
9.5.2
APPROPRIATENESS OF MEASUREMENTS
9.5.3
IMMUNOGENICITY VARIABLES
9.6
9.7
9.7.1
9.7.2
9.8
9.8.1
PROTOCOL AMENDMENTS
Page 16 of 22
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=
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
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
Page 17 of 22
Death
Other
Source Data: Listing xx:
Protocol deviations
Deviation
Entry criteria
Withdrawal criteria
Incorrect dosing regimen
Concomitant
treatment/medication
Other
Site:
Site:
0
0
0
0
0
0
0
0
Page 18 of 22
11 RESULTS
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=)
Page 19 of 22
ANALYSIS OF IMMUNOGENECITY
11.5.2
STATISTICAL/ANALYTICAL ISSUES
11.5.4
11.5.5
BY-PATIENT DISPLAYS
11.5.6
IMMUNOGENECITY CONCLUSIONS
12 SAFETY EVALUATION
12.1 EXTENT OF EXPOSURE
12.2.1
12.2.2
12.2.3
12.2.4
IMMUNISATION TOLERANCE
Page 20 of 22
12.4
DEATHS
12.5.1
13
15 REFERENCES
16 APPENDICES
16.1
STUDY INFORMATION
16.1.1
16.1.2
16.1.3
16.1.4
Regulatory Approval
16.1.5
Page 21 of 22
16.1.6
16.1.7
Randomisation Code
16.1.8
Study Drugs
16.1.9
Audit Certificate
16.1.10
16.1.11
16.1.12
16.1.13
16.2
16.3
16.3.1
CRFs for deaths, other serious adverse events and withdrawals for AE
16.3.2
Page 22 of 22