SOP for EC Registration Verification and Communications (Country-Specific)

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Published on 23/12/2025

Standard Operating Procedure for EC Registration Verification and Communications (Country-Specific)

SOP No.	CR/OPS/146/2025
Supersedes	NA
Page No.	X of Y
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Table of Contents

Purpose

The purpose of this SOP is to establish procedures for verifying Ethics Committee (EC) registrations and managing communications with ECs in compliance with the

Drugs Controller General of India (DCGI), CDSCO, and the New Drugs and Clinical Trials Rules (NDCTR) 2019. This ensures that all ECs involved in clinical trials are properly registered and that communications meet country-specific regulatory requirements.

Scope

This SOP applies to sponsors, CROs, investigators, and regulatory affairs personnel involved in Indian clinical trials. It covers verification of EC registration with CDSCO, documentation of communications, and reporting obligations to ensure compliance with NDCTR and ICMR guidelines.

Responsibilities

Sponsor: Ensures all trial ECs are registered and maintains EC registration records in the TMF.
Investigator: Confirms EC registration at site and provides updates to sponsor/CRO.
CRO: Verifies EC registration for participating sites and tracks communications.
EC: Maintains valid registration, renewals, and responds to sponsor/authority communications.
QA: Audits EC registration verification and communications for compliance.

Accountability

The Sponsor’s Regulatory Affairs Head is accountable for ensuring EC registration verification and documentation of all communications.

Procedure

1. Verification of EC Registration
1.1 Collect EC registration details from sites prior to trial initiation.
1.2 Verify registration against CDSCO’s official EC registry.
1.3 Document in EC Registration Verification Log (Annexure-1).

2. Renewal Tracking
2.1 Ensure EC registrations remain valid throughout trial duration.
2.2 Document in EC Renewal Tracking Log (Annexure-2).

3. Communication Management
3.1 Maintain official communications (queries, approvals, acknowledgments).
3.2 Archive communications in TMF and ISF.
3.3 Record in EC Communications Log (Annexure-3).

4. Non-Compliance Handling
4.1 If EC is not registered, escalate to sponsor and regulatory authority.
4.2 Document in Non-Compliance Log (Annexure-4).

5. Inspection Readiness
5.1 Ensure EC registrations and communications are audit-ready.
5.2 Document periodic QA checks in EC Audit Log (Annexure-5).

Abbreviations

SOP: Standard Operating Procedure
EC: Ethics Committee
DCGI: Drugs Controller General of India
CDSCO: Central Drugs Standard Control Organization
CRO: Contract Research Organization
QA: Quality Assurance
TMF: Trial Master File
ISF: Investigator Site File
NDCTR: New Drugs and Clinical Trials Rules
ICMR: Indian Council of Medical Research

Documents

EC Registration Verification Log (Annexure-1)
EC Renewal Tracking Log (Annexure-2)
EC Communications Log (Annexure-3)
Non-Compliance Log (Annexure-4)
EC Audit Log (Annexure-5)

References

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, Regulatory Affairs Specialist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Clinical Operations

Annexures

Annexure-1: EC Registration Verification Log

Date	Site	EC Name	Registration No.	Verified By
01/09/2025	Mumbai Site	XYZ Hospital EC	CDSCO/EC/2023/105	Reg Affairs

Annexure-2: EC Renewal Tracking Log

Date	EC Name	Renewal Due	Status	Checked By
10/09/2025	XYZ Hospital EC	12/2026	Valid	QA

Annexure-3: EC Communications Log

Date	Protocol ID	Communication Type	Sent/Received By	Status
12/09/2025	CTA-2025-03	Approval Letter	EC	Archived

Annexure-4: Non-Compliance Log

Date	Site	EC Name	Issue	Status
15/09/2025	Delhi Site	ABC Hospital EC	Registration Expired	Escalated

Annexure-5: EC Audit Log

Date	Audit Type	Performed By	Status
20/09/2025	Mock Audit	QA	Compliant

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head Clinical Operations

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