{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.clinicalstudies.in/sop-for-ec-registration-verification-and-communications-country-specific”
},
“headline”: “SOP for EC Registration Verification and Communications (Country-Specific)”,
“description”: “This SOP defines procedures for verifying Ethics Committee (EC) registrations with DCGI and ensuring proper country-specific communications. It establishes sponsor, investigator, and CRO responsibilities to maintain compliance with NDCTR 2019 requirements and CDSCO regulations.”,
“author”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”
},
“publisher”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”,
“logo”: {
“@type”: “ImageObject”,
“url”: “https://www.clinicalstudies.in/logo.png”
}
},
“datePublished”: “2025-08-26”,
“dateModified”: “2025-08-26”
}

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

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

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

References

• CDSCO – Central Drugs Standard Control Organization
• New Drugs and Clinical Trials Rules, 2019
• ICMR – National Ethical Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: EC Registration Verification Log

Annexure-2: EC Renewal Tracking Log

Annexure-3: EC Communications Log

Annexure-4: Non-Compliance Log

Annexure-5: EC Audit Log

Revision History

For more SOPs visit: Pharma SOP