Standard Operating Procedure for Creating Clinical Site Master File in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/129/2025 |
| Supersedes | SOP/BA-BE/129/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a procedure for compiling, maintaining, and archiving the Clinical Site Master File (CSMF) for each clinical trial site involved in bioavailability/bioequivalence (BA/BE) studies to ensure regulatory compliance and data traceability.
2. Scope
This SOP applies to clinical trial coordinators, monitors, principal investigators, and QA personnel responsible for document control and site documentation during BA/BE clinical studies.
3. Responsibilities
- Study Coordinator: Compiles and maintains the site master file as per the checklist.
- Clinical Monitor (CRA): Reviews file completeness during monitoring visits.
- Principal Investigator: Ensures site compliance with documentation requirements.
- QA Officer: Audits CSMF for completeness and GCP compliance.
4. Accountability
The Clinical Operations Manager is accountable for ensuring each site maintains a current, complete, and audit-ready CSMF throughout the lifecycle of the BA/BE study.
5. Procedure
5.1 Structure of the Clinical Site Master File
- The CSMF must be maintained in a structured format with the following sections:
- Section A – Regulatory and Ethics Documents
- Section B – Site Personnel Documents
- Section C – Study Specific Documents
- Section D – Subject Related Documents
- Section E – Laboratory and Facility Documents
- Section F – Monitoring and Audit Records
5.2 Initial Compilation
- Initiate the CSMF upon site qualification or initiation visit.
- Use Annexure-1: CSMF Table of Contents Checklist to track completeness.
- Ensure documents are filed in chronological order and signed, dated, and version controlled.
5.3 Document Inclusion and Updating
- Inclusion of:
- IRB/IEC approvals
- Protocol, amendments, IB, CRFs
- Training logs, delegation logs, CVs, GCP certificates
- Signed informed consents, SAE forms, protocol deviation logs
- Update the file continuously as new documents are generated or approved.
- File periodic monitoring reports, query resolutions, and audit reports.
5.4 Review and Monitoring
- The CRA must:
- Review the CSMF during each monitoring visit
- Log findings and deficiencies in Annexure-2: CSMF Monitoring Checklist
- Corrective actions must be initiated immediately for missing or incorrect files.
5.5 Closure and Archival
- On study close-out, the CSMF must be reviewed for final completeness.
- CRA and PI must sign Annexure-3: CSMF Closure Certificate.
- Archive file securely for a minimum of 5 years or as per regulatory guidelines.
6. Abbreviations
- CSMF: Clinical Site Master File
- CRA: Clinical Research Associate
- BA: Bioavailability
- BE: Bioequivalence
- IRB: Institutional Review Board
- IEC: Institutional Ethics Committee
- QA: Quality Assurance
7. Documents
- CSMF Table of Contents Checklist – Annexure-1
- CSMF Monitoring Checklist – Annexure-2
- CSMF Closure Certificate – Annexure-3
8. References
- ICH E6(R2) – Good Clinical Practice
- WHO GCP Handbook
- Schedule Y – Drugs and Cosmetics Rules, India
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: CSMF Table of Contents Checklist
| Section | Document | Included (Yes/No) | Remarks |
|---|---|---|---|
| A | IRB Approval Letter | Yes | Approved on 10/03/2025 |
| B | PI CV & GCP Certificate | Yes | Filed and signed |
Annexure-2: CSMF Monitoring Checklist
| Visit Date | Reviewed By | Missing Documents | Corrective Action |
|---|---|---|---|
| 15/04/2025 | Sunita Reddy | Training log | Updated and filed |
Annexure-3: CSMF Closure Certificate
| Site | PI | CRA | Date of Closure | Remarks |
|---|---|---|---|---|
| XYZ Clinical Unit | Dr. Meena Joshi | Ajay Verma | 17/04/2025 | All documents filed |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP release | Regulatory Requirement | QA Head |
| 17/04/2025 | 2.0 | Section structure and monitoring checklist added | Internal SOP Harmonization | QA Head |