SOP Guide for Pharma

BA-BE Studies: SOP for Creating Clinical Site Master File – V 2.0

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BA-BE Studies: SOP for Creating Clinical Site Master File – V 2.0

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.
See also  BA-BE Studies: SOP for Emergency Medical Handling in BE Units - V 2.0

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

  1. 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

  1. Initiate the CSMF upon site qualification or initiation visit.
  2. Use Annexure-1: CSMF Table of Contents Checklist to track completeness.
  3. Ensure documents are filed in chronological order and signed, dated, and version controlled.

5.3 Document Inclusion and Updating

  1. Inclusion of:
    • IRB/IEC approvals
    • Protocol, amendments, IB, CRFs
    • Training logs, delegation logs, CVs, GCP certificates
    • Signed informed consents, SAE forms, protocol deviation logs
  2. Update the file continuously as new documents are generated or approved.
  3. File periodic monitoring reports, query resolutions, and audit reports.
See also  BA-BE Studies: SOP for Administration of Study Drug in Fed State - V 2.0

5.4 Review and Monitoring

  1. The CRA must:
    • Review the CSMF during each monitoring visit
    • Log findings and deficiencies in Annexure-2: CSMF Monitoring Checklist
  2. Corrective actions must be initiated immediately for missing or incorrect files.

5.5 Closure and Archival

  1. On study close-out, the CSMF must be reviewed for final completeness.
  2. CRA and PI must sign Annexure-3: CSMF Closure Certificate.
  3. 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

  1. CSMF Table of Contents Checklist – Annexure-1
  2. CSMF Monitoring Checklist – Annexure-2
  3. CSMF Closure Certificate – Annexure-3

8. References

  • ICH E6(R2) – Good Clinical Practice
  • WHO GCP Handbook
  • Schedule Y – Drugs and Cosmetics Rules, India
See also  BA-BE Studies: SOP for Clinical Trial Material (CTM) Receipt Log - V 2.0

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
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