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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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Standard Operating Procedure for AV Recording of Consent (NCEs; Defined Therapy Areas) and Retention

Purpose

The purpose of this SOP is to establish standardized procedures for mandatory audio-visual (AV) recording of the informed consent process in clinical trials involving New Chemical Entities (NCEs) and specific therapy areas as required by the Drugs Controller General of India (DCGI) under the New Drugs and Clinical Trials Rules (NDCTR), 2019. It ensures subject rights, transparency, and regulatory compliance.

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

1. AV Equipment Log (Annexure-1)
2. AV Consent Recording Log (Annexure-2)
3. AV Storage Log (Annexure-3)
4. AV Access Log (Annexure-4)
5. AV Protocol Amendment Log (Annexure-5)
6. 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

Annexures

Annexure-1: AV Equipment Log

Annexure-2: AV Consent Recording Log

Annexure-3: AV Storage Log

Annexure-4: AV Access Log

Annexure-5: AV Protocol Amendment Log

Annexure-6: AV Audit Log

Revision History

For more SOPs visit: Pharma SOP