reports, logs, SOPs, training records, and facility documentation.

3. Responsibilities

• Document Control Officer (DCO): Manages document issuance, versioning, archiving, and master list maintenance.
• Clinical Research Coordinator: Requests documents and ensures accurate use of controlled versions.
• QA Personnel: Audits document control systems, performs reviews, and approves version changes.
• Study Team Members: Ensure correct documentation, completion, and timely submission.

4. Accountability

The Clinical Operations Manager is accountable for ensuring proper document control practices are implemented and maintained as per GCP and regulatory guidelines.

5. Procedure

5.1 Document Classification

1. Classify clinical documents into:
   • Controlled Documents (e.g., ICF, CRF, SOPs, log templates)
   • Uncontrolled/Internal Records (e.g., subject screening forms, drafts)

5.2 Document Numbering and Versioning

1. Assign each controlled document a unique identifier:
   • Format: DOC/BA-BE/XXX/YYYY
2. Update version number with every approved change (e.g., V1.0 to V2.0).
3. Document version history in Annexure-1: Document Version Control Log.

5.3 Creation and Review

1. Document drafts are prepared by responsible personnel and submitted to DCO.
2. DCO routes draft to QA and study team for review and approval.
3. Once approved, document is locked as “Controlled” and released for use.

5.4 Distribution and Use

1. Only controlled hard copies or electronically signed PDFs shall be used.
2. Use Annexure-2: Controlled Document Issuance Register to track recipients and issuance date.
3. Obsolete versions must be withdrawn, marked “Superseded,” and archived.

5.5 Archival and Retrieval

1. All completed logs, forms, and reports must be filed in the Investigator Site File (ISF) and Study Master File (SMF).
2. Archive hard copies in lockable fire-resistant cabinets with restricted access.
3. Maintain digital backups in a validated document management system (DMS).
4. Record retrievals using Annexure-3: Document Access Log.

5.6 Deviations and CAPA

1. If incorrect document version is used:
   • Record deviation in Annexure-4: Document Control Deviation Form
   • Initiate root cause analysis and implement CAPA

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• DCO: Document Control Officer
• CRF: Case Report Form
• ICF: Informed Consent Form
• DMS: Document Management System
• ISF: Investigator Site File
• SMF: Study Master File
• CAPA: Corrective and Preventive Action

7. Documents

1. Document Version Control Log – Annexure-1
2. Controlled Document Issuance Register – Annexure-2
3. Document Access Log – Annexure-3
4. Document Control Deviation Form – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• WHO GCP Handbook
• 21 CFR Part 11 – Electronic Records and Signatures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Document Version Control Log

Document Title	Doc No.	Version	Effective Date	Status
Volunteer Screening Log	DOC/BA-BE/001/2025	V2.0	15/04/2025	Active

Annexure-2: Controlled Document Issuance Register

Date	Document Title	Issued To	Version	Signature
17/04/2025	ICF English	Rajesh Kumar	V2.0	Signed

Annexure-3: Document Access Log

Date	User	Document Accessed	Purpose	Authorized By
16/04/2025	Sunita Reddy	CRF Template	Subject Data Entry	QA Head

Annexure-4: Document Control Deviation Form

Date	Description of Deviation	Root Cause	CAPA	Closed By
15/04/2025	Old ICF used	Uncontrolled printout	Document log revised	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial Release	GCP Compliance	QA Head
17/04/2025	2.0	Expanded scope, added electronic document control and CAPA sections	Audit Requirement	QA Head