Standard Operating Procedure for Preparing Clinical Investigator’s Brochure (CIB) in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/030/2025 |
| Supersedes | SOP/BA-BE/030/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define a standardized procedure for the preparation, review, approval, and distribution of the Clinical Investigator’s Brochure (CIB) for Bioavailability/Bioequivalence (BA/BE) studies, ensuring it contains comprehensive safety, efficacy, and pharmacological information for investigators.
2. Scope
This SOP applies to all BA/BE studies sponsored or managed by the organization that require submission of a CIB to the Ethics Committee (EC), Central Licensing Authority (e.g., CDSCO), and study investigators.
3. Responsibilities
- Medical Writing: Prepares the CIB draft based on available data.
- Clinical Research: Provides clinical summaries and study design information.
- Pharmacovigilance: Provides safety and adverse event profile.
- Regulatory Affairs: Ensures alignment with regulatory requirements and submission timelines.
4. Accountability
The Head of Clinical Development is accountable for the accuracy, completeness, and timely finalization of the CIB and for ensuring it is made available to all investigators prior to study initiation.
5. Procedure
5.1 CIB Template and Contents
- Use organization-approved CIB template that includes:
- Title Page and Table of Contents
- Product Information
- Summary of Nonclinical Pharmacology and Toxicology
- Summary of Clinical Pharmacokinetics
- Clinical Safety Summary
- Known and Potential Risks
- Guidance for Investigators (dosing, storage, contraindications)
5.2 Data Source Compilation
- Collect and reference information from:
- Product Monographs and SmPCs
- Published literature and review articles
- Internal PK/PD study data
- Adverse event and post-marketing safety reports
5.3 Drafting and Review
- Medical Writer compiles the CIB in coordination with Clinical, Safety, and Regulatory teams.
- Circulate the draft for internal review and obtain feedback through Annexure-1: CIB Review Tracker.
- Update and finalize based on consolidated comments.
5.4 Approval and Version Control
- Finalize version with appropriate version number, date, and confidentiality statement.
- Route the final document for approval using Annexure-2: CIB Approval Log.
5.5 Distribution and Archiving
- Provide electronic and/or physical copies to:
- All study investigators
- Regulatory authorities (if required)
- Ethics Committees
- Maintain the final approved CIB in TMF/eTMF with proper access control.
6. Abbreviations
- CIB: Clinical Investigator’s Brochure
- PK: Pharmacokinetics
- PD: Pharmacodynamics
- SmPC: Summary of Product Characteristics
- TMF: Trial Master File
7. Documents
- CIB Review Tracker – Annexure-1
- CIB Approval Log – Annexure-2
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- ICH E3 – Structure and Content of Clinical Study Reports
- CDSCO Guidance on Clinical Trials and Documentation
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: CIB Review Tracker
| Reviewer | Department | Date Reviewed | Comments | Resolution Status |
|---|---|---|---|---|
| Sunita Reddy | Regulatory Affairs | 15/04/2025 | Include recent AE profile | Resolved |
Annexure-2: CIB Approval Log
| Name | Designation | Department | Date Approved | Signature |
|---|---|---|---|---|
| Dr. Meera Shah | Head – Clinical Research | Clinical | 17/04/2025 |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP | New implementation | QA Head |
| 17/04/2025 | 2.0 | Added annexures, clarified content structure | ICH E6(R2) compliance | QA Head |