9.0 KiB
Clinical Study Report (CSR) Template
ICH-E3 Format
TITLE PAGE
Study Title: [Full descriptive title including compound, indication, phase]
Protocol Number: [Sponsor protocol number]
Protocol Version: [Final protocol version and date]
Sponsor: [Company name and address]
Compound/Drug Name: [Generic and proprietary names, compound code]
Indication: [Therapeutic area and specific indication studied]
Study Phase: [I / II / III / IV]
Study Type: [Interventional / Observational]
Report Date: [MM/DD/YYYY]
Report Version: [Version number]
Medical Expert: [Name, MD, Title]
Biostatistician: [Name, PhD, Title]
Confidentiality Statement: "This document contains confidential information belonging to [Sponsor]. It may not be reproduced or distributed without permission."
SYNOPSIS
Title: [Abbreviated title]
Protocol Number: [Number]
Study Phase: [Phase]
Study Period: [Start date - End date]
Study Objectives
Primary Objective: [State primary objective clearly and concisely]
Secondary Objectives:
- [Secondary objective 1]
- [Secondary objective 2]
Methodology
Study Design: [Randomized, double-blind, placebo-controlled, parallel-group, etc.]
Study Population:
- Target population: [Patient population]
- Key inclusion criteria: [Main criteria]
- Key exclusion criteria: [Main criteria]
Sample Size:
- Planned: [N participants]
- Randomized: [N participants]
- Completed: [N participants]
Treatment:
- Treatment A: [Drug name, dose, route, frequency]
- Treatment B: [Comparator/placebo]
- Treatment duration: [Weeks/months]
- Follow-up duration: [Weeks/months]
Endpoints:
Primary:
- [Primary endpoint definition and timepoint]
Secondary:
- [Secondary endpoint 1]
- [Secondary endpoint 2]
Statistical Methods: [Brief description of analysis approach, significance level, handling of multiplicity]
Results
Participant Disposition:
- Screened: [N]
- Randomized: [N Treatment A, N Treatment B]
- Completed: [N Treatment A, N Treatment B]
- Discontinued: [N overall, % - main reasons]
Demographics and Baseline: [Summary of key baseline characteristics, comparability across groups]
Efficacy Results:
Primary Endpoint:
- [Result for Treatment A vs B, effect size, 95% CI, p-value]
Secondary Endpoints:
- [Results for each secondary endpoint]
Safety Results:
- Any AE: [% Treatment A vs B]
- Treatment-related AE: [% Treatment A vs B]
- Serious AE: [% Treatment A vs B]
- Discontinuations due to AE: [% Treatment A vs B]
- Deaths: [N Treatment A vs B]
- Common AEs (≥5%): [List with percentages]
Conclusions
[Overall conclusions regarding efficacy and safety, benefit-risk assessment]
TABLE OF CONTENTS
[Detailed table of contents with page numbers]
LIST OF ABBREVIATIONS
| Abbreviation | Definition |
|---|---|
| AE | Adverse Event |
| ANCOVA | Analysis of Covariance |
| CI | Confidence Interval |
| CSR | Clinical Study Report |
| FAS | Full Analysis Set |
| GCP | Good Clinical Practice |
| ICF | Informed Consent Form |
| ITT | Intent-to-Treat |
| PP | Per-Protocol |
| SAE | Serious Adverse Event |
| SD | Standard Deviation |
| [Add study-specific abbreviations] |
ETHICS (Section 2)
2.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB)
[List of all IECs/IRBs that approved the study]
| Site Number | Institution | IRB/IEC Name | Approval Date |
|---|---|---|---|
| 001 | [Institution] | [IRB name] | [MM/DD/YYYY] |
2.2 Ethical Conduct of the Study
This study was conducted in accordance with:
- ICH Good Clinical Practice (GCP) E6(R2)
- Declaration of Helsinki (current version)
- Applicable regulatory requirements
- Sponsor Standard Operating Procedures
2.3 Patient Information and Consent
Informed consent was obtained from all participants before any study-specific procedures. The informed consent process included:
- Written information about study purpose, procedures, risks, and benefits
- Opportunity to ask questions
- Voluntary participation with right to withdraw
- Signatures of participant and person obtaining consent
- Copy provided to participant
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE (Section 3)
3.1 Investigators and Study Centers
[Table listing all investigators, sites, and enrollment]
| Site No. | Investigator | Institution | City, Country | Subjects Enrolled |
|---|---|---|---|---|
| 001 | [Name, MD] | [Institution] | [City, Country] | [N] |
Coordinating Investigator: [Name, if applicable]
3.2 Study Administrative Structure
Sponsor:
- Medical Monitor: [Name, credentials]
- Project Manager: [Name]
- Biostatistician: [Name, credentials]
Contract Research Organization (CRO): [Name, if applicable]
- [Responsibilities]
3.3 Responsibilities of Parties Involved
[Description of sponsor, investigator, CRO, DSMB responsibilities]
INTRODUCTION (Section 4)
4.1 Background
[Detailed background on disease/condition, unmet medical need, treatment landscape]
4.2 Nonclinical Studies
[Summary of relevant preclinical pharmacology, toxicology, and safety findings]
4.3 Previous Clinical Studies
[Summary of prior clinical experience with investigational product]
4.4 Study Rationale and Objectives
[Justification for conducting this study, specific objectives]
STUDY OBJECTIVES AND PLAN (Section 5)
5.1 Objectives and Endpoints
Primary Objective: [Objective statement]
Primary Endpoint: [Detailed endpoint definition, measurement method, timepoint]
Secondary Objectives:
- [Objective]
- [Objective]
Secondary Endpoints:
- [Endpoint definition]
- [Endpoint definition]
5.2 Study Design
[Detailed description of study design with diagram if helpful]
Design Type: [Parallel, crossover, factorial, etc.] Blinding: [Double-blind, open-label, etc.] Randomization: [1:1, 2:1, stratified, etc.] Duration: [Treatment period, follow-up period]
Study Schema: [Flow diagram showing screening, randomization, treatment periods, follow-up]
5.3 Study Population
Key Inclusion Criteria:
- [Criterion]
- [Criterion]
Key Exclusion Criteria:
- [Criterion]
- [Criterion]
5.4 Treatments
Investigational Product:
- Name: [Generic, trade, code]
- Formulation: [Tablet, capsule, injection]
- Dose: [Dose and regimen]
- Route: [PO, IV, SC, etc.]
- Packaging and labeling: [Description]
Comparator: [Similar details for comparator or placebo]
Concomitant Medications: [Permitted and prohibited medications]
5.5 Sample Size Determination
Target Sample Size: [N per group, N total]
Justification:
- Assumed effect size: [Value]
- Variability (SD): [Value]
- Type I error (α): [0.05]
- Power (1-β): [80% or 90%]
- Expected dropout rate: [%]
- Two-sided test
5.6 Statistical Analysis Plan
Analysis Populations:
- Full Analysis Set (FAS): [Definition]
- Per-Protocol Set (PPS): [Definition]
- Safety Analysis Set: [Definition]
Statistical Methods:
- Primary endpoint: [Method - e.g., ANCOVA with baseline as covariate]
- Secondary endpoints: [Methods]
- Handling of missing data: [Approach]
- Multiplicity adjustment: [Method if applicable]
- Interim analyses: [If planned]
Significance Level: α = 0.05 (two-sided)
STUDY PATIENTS (Section 6)
6.1 Disposition of Patients
Participant Flow (CONSORT Diagram):
[Include detailed CONSORT diagram showing screening through analysis]
Summary Table:
| Category | Treatment A | Treatment B | Total |
|---|---|---|---|
| Screened | N | N | N |
| Screen failures | N (%) | N (%) | N (%) |
| Randomized | N | N | N |
| Received treatment | N (%) | N (%) | N (%) |
| Completed | N (%) | N (%) | N (%) |
| Discontinued | N (%) | N (%) | N (%) |
| - Adverse event | N (%) | N (%) | N (%) |
| - Lack of efficacy | N (%) | N (%) | N (%) |
| - Lost to follow-up | N (%) | N (%) | N (%) |
| - Withdrawal of consent | N (%) | N (%) | N (%) |
| - Other | N (%) | N (%) | N (%) |
6.2 Protocol Deviations
Major Protocol Deviations: [Summary of major deviations, impact on data, subjects affected]
Important Protocol Deviations by Category:
| Deviation Type | Treatment A | Treatment B | Total |
|---|---|---|---|
| Inclusion/exclusion criteria | N (%) | N (%) | N (%) |
| Dosing errors | N (%) | N (%) | N (%) |
| Prohibited medications | N (%) | N (%) | N (%) |
| Missed visits | N (%) | N (%) | N (%) |
(Continues with sections 7-14 following ICH-E3 structure...)
Note: This is an abbreviated template. A complete CSR following ICH-E3 is typically 50-300 pages with extensive appendices. Key sections to complete:
- Section 7: Efficacy Evaluation
- Section 8: Safety Evaluation
- Section 9: Discussion and Overall Conclusions
- Section 10: Tables, Figures, and Graphs
- Section 11: References
- Section 12-14: Appendices (Protocol, CRFs, Investigator list, etc.)