Standard Operating Procedure for Setting Up eTMF (Electronic Trial Master File) in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/042/2025
Supersedes	SOP/BA-BE/042/2022
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 the procedure for establishing and maintaining an Electronic Trial Master File (eTMF) system for BA/BE studies, ensuring real-time documentation, compliance with ICH-GCP guidelines, and audit readiness.

2. Scope

This SOP applies to all BA/BE studies where an eTMF is implemented to manage essential documents throughout the study lifecycle including planning, conduct, and closeout phases.

3. Responsibilities

• Clinical Document Manager: Leads the eTMF setup, configuration, and maintenance activities.
• Clinical Project Manager (CPM): Ensures timely upload and completeness of study-specific documents.
• Quality Assurance: Reviews eTMF structure and compliance during audits.
• IT Department: Provides technical support for access control, data backup, and software validation.

4. Accountability

The Head of Clinical Operations is accountable for ensuring the eTMF system is implemented, validated, and maintained in compliance with regulatory standards and internal policies.

5. Procedure

5.1 Selection and Validation of eTMF System

1. Select a validated eTMF platform with 21 CFR Part 11 compliance.
2. Complete IT validation documentation including user requirement specifications (URS), functional specification (FS), and validation summary report.

5.2 Folder Structure and Metadata Setup

1. Configure the folder structure as per the DIA Reference Model (Annexure-1: eTMF Folder Mapping).
2. Assign document metadata fields such as:
   • Study ID
   • Country/Site
   • Document Type
   • Version
   • Date

5.3 User Access and Permissions

1. Define user roles and access levels (e.g., Viewer, Editor, Approver).
2. Maintain user list in Annexure-2: eTMF Access Log.

5.4 Document Upload and QC

1. Upload essential documents into the appropriate folders following standardized naming conventions.
2. Each document must be reviewed and quality-checked before final approval.
3. Track version history and archival status for every file.

5.5 Milestone Tracking and Completeness Check

1. Configure milestone-based document tracking (e.g., Site Initiation, First Subject First Visit, Database Lock).
2. Use Annexure-3: eTMF Completeness Checklist to monitor document availability for each milestone.

5.6 Archival and Closeout

1. Post-study, lock the eTMF and generate audit trail report.
2. Export eTMF to secure archival location with backup maintained for 15 years (or as per regional regulations).

6. Abbreviations

• eTMF: Electronic Trial Master File
• CPM: Clinical Project Manager
• GCP: Good Clinical Practice
• DIA: Drug Information Association
• URS: User Requirement Specification

7. Documents

1. eTMF Folder Mapping – Annexure-1
2. eTMF Access Log – Annexure-2
3. eTMF Completeness Checklist – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• 21 CFR Part 11 – Electronic Records and Signatures
• DIA TMF Reference Model

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: eTMF Folder Mapping

Section	Folder Name	Description
01	Trial Management	Study plans, meeting minutes, Gantt charts
02	Central Trial Documents	Protocol, IB, protocol amendments

Annexure-2: eTMF Access Log

User Name	Role	Access Level	Date Activated	Status
Rajesh Kumar	CPM	Editor	01/04/2025	Active

Annexure-3: eTMF Completeness Checklist

Milestone	Document Type	Available (Y/N)	Remarks
Study Start-Up	EC Approval Letter	Y	Uploaded on 12/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP	eTMF process implementation	QA Head
17/04/2025	2.0	Added DIA model alignment and Annexures	Regulatory audit readiness	QA Head