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“headline”: “SOP for AV Recording of Consent (NCEs; Defined Therapy Areas) and Retention”,
“description”: “This SOP defines procedures for mandatory audio-visual (AV) recording of informed consent in Indian clinical trials involving new chemical entities (NCEs) and defined therapy areas. It covers technical requirements, storage, retention, and compliance with DCGI/CDSCO and NDCTR 2019 rules.”,
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“datePublished”: “2025-08-26”,
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Published on 21/12/2025
Standard Operating Procedure for AV Recording of Consent (NCEs; Defined Therapy Areas) and Retention
| SOP No. | CR/OPS/144/2025 |
| Supersedes | NA |
| Page No. | X of Y |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to
Scope
This SOP applies to investigators, sponsors, CROs, ethics committees, and site staff involved in clinical trials requiring AV recording of consent. It covers equipment requirements, recording procedures, secure storage, retention timelines, and regulatory audit preparedness.
Responsibilities
- Investigator: Ensures AV recording is performed for every informed consent interaction where mandated.
- Sponsor: Provides resources and oversight for AV recording and storage systems.
- CRO: Monitors compliance with AV recording SOPs across trial sites.
- EC/IRB: Verifies AV consent documentation during continuing reviews.
- QA: Audits AV recording practices and storage compliance.
Accountability
The Principal Investigator (PI) is accountable for ensuring AV recording of consent is properly executed, documented, and retained in compliance with NDCTR 2019 and DCGI notifications.
Procedure
1. Equipment Setup
1.1 Ensure recording equipment is functional and located in a private, secure space.
1.2 Test audio and video quality before initiating consent discussions.
1.3 Document setup in AV Equipment Log (Annexure-1).
2. Recording Consent
2.1 Begin recording before initiation of consent explanation.
2.2 Capture full interaction: explanation of trial, subject questions, voluntary agreement.
2.3 Record both subject and investigator identities.
2.4 Document in AV Consent Recording Log (Annexure-2).
3. Retention and Storage
3.1 Store recordings securely in encrypted systems or locked physical storage devices.
3.2 Retain recordings for a minimum of 25 years as per NDCTR requirements.
3.3 Record storage details in AV Storage Log (Annexure-3).
4. Data Confidentiality
4.1 Restrict access to authorized personnel only.
4.2 Record all access events in AV Access Log (Annexure-4).
5. Protocol Amendments
5.1 If therapy area or scope expands, update AV consent process accordingly.
5.2 Track amendments in AV Protocol Amendment Log (Annexure-5).
6. Audit and Inspection
6.1 Ensure inspection readiness of AV recordings for DCGI and EC audits.
6.2 Document audits in AV Audit Log (Annexure-6).
Abbreviations
- SOP: Standard Operating Procedure
- AV: Audio-Visual
- NCE: New Chemical Entity
- DCGI: Drugs Controller General of India
- CDSCO: Central Drugs Standard Control Organization
- CRO: Contract Research Organization
- QA: Quality Assurance
- NDCTR: New Drugs and Clinical Trials Rules
- EC/IRB: Ethics Committee/Institutional Review Board
Documents
- AV Equipment Log (Annexure-1)
- AV Consent Recording Log (Annexure-2)
- AV Storage Log (Annexure-3)
- AV Access Log (Annexure-4)
- AV Protocol Amendment Log (Annexure-5)
- AV Audit Log (Annexure-6)
References
- CDSCO – Central Drugs Standard Control Organization
- New Drugs and Clinical Trials Rules, 2019
- ICH GCP Guidelines
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Clinical Research Coordinator |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Principal Investigator |
Annexures
Annexure-1: AV Equipment Log
| Date | Site | Equipment Tested | Checked By | Status |
|---|---|---|---|---|
| 01/09/2025 | Delhi Site | Camera + Mic | Site Staff | Working |
Annexure-2: AV Consent Recording Log
| Date | Subject ID | Investigator | Witness | Status |
|---|---|---|---|---|
| 02/09/2025 | SUB-101 | Dr. Mehta | Mr. Singh | Completed |
Annexure-3: AV Storage Log
| Date | Storage Location | Secured By | Status |
|---|---|---|---|
| 03/09/2025 | Encrypted Drive | IT Admin | Locked |
Annexure-4: AV Access Log
| Date | User | Reason for Access | Authorized By | Status |
|---|---|---|---|---|
| 05/09/2025 | QA Officer | Audit Review | Sponsor | Approved |
Annexure-5: AV Protocol Amendment Log
| Date | Amendment | Protocol ID | Submitted By | Status |
|---|---|---|---|---|
| 07/09/2025 | Therapy Area Expansion | CTA-2025-02 | Reg Affairs | Approved |
Annexure-6: AV Audit Log
| Date | Audit Type | Performed By | Status |
|---|---|---|---|
| 10/09/2025 | DCGI Readiness | QA | Compliant |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Principal Investigator |
For more SOPs visit: Pharma SOP