Standard Operating Procedure for Audio-Visual Consent Recording in India for BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/024/2025
Supersedes	SOP/BA-BE/024/2022
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 conducting, documenting, and storing audio-visual (AV) recordings of the informed consent process for BA/BE studies conducted in India, as per the requirements of the CDSCO and Indian regulatory authorities.

2. Scope

This SOP applies to all BA/BE studies involving human participants in India where audio-visual recording of the informed consent process is mandated as per GSR 611(E) notification and Schedule Y guidelines.

3. Responsibilities

• Investigator: Conducts the AV consent session and ensures participant understanding.
• Clinical Staff/Nurse: Coordinates logistics and manages recording equipment.
• Regulatory Affairs: Ensures process compliance and storage requirements are met.
• IT/AV Technician: Assists in setup, testing, and file management of recordings.

4. Accountability

The Principal Investigator is accountable for the ethical and regulatory compliance of the AV consent process and the secure storage of recordings for the retention period.

5. Procedure

5.1 Preparation for AV Recording

1. Identify private and quiet space with good lighting and audio conditions.
2. Ensure backup recording device is available (in case of failure).
3. Use Annexure-1: AV Consent Equipment Checklist to verify readiness.

5.2 Conduct of AV Consent

1. Begin recording and introduce all participants in the frame:
   • Participant
   • Investigator
   • Witness (if participant is illiterate)
2. Explain:
   • Study objective, duration, and procedures
   • Risks and benefits
   • Right to withdraw
   • Compensation policy
3. Encourage questions and record verbal consent from the participant.
4. Document that the participant voluntarily agrees to participate.

5.3 Consent Documentation

1. After AV recording, obtain participant’s signature on physical ICF.
2. Record the AV file ID on the signed ICF and log it in Annexure-2: AV Consent Master Log.

5.4 File Storage and Backup

1. Label the AV file using unique subject ID and date (e.g., BE031_SUB001_170425.mp4).
2. Store files securely in encrypted folders with restricted access.
3. Create backup in a validated external drive or server location.
4. Retain files for a minimum of 5 years or as per sponsor/GCP requirements.

5.5 Audit and Review

1. Ensure availability of files for EC, CDSCO, or sponsor audit when requested.
2. Review recordings quarterly for quality checks as per Annexure-3: AV Quality Review Log.

6. Abbreviations

• AV: Audio-Visual
• ICF: Informed Consent Form
• EC: Ethics Committee
• CDSCO: Central Drugs Standard Control Organization
• PI: Principal Investigator

7. Documents

1. AV Consent Equipment Checklist – Annexure-1
2. AV Consent Master Log – Annexure-2
3. AV Quality Review Log – Annexure-3

8. References

• Schedule Y – Drugs and Cosmetics Rules
• GSR 611(E), 2014 – Audio-Visual Consent Guidelines
• ICMR National Ethical Guidelines, 2017
• ICH E6(R2) – Good Clinical Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: AV Consent Equipment Checklist

Item	Status	Remarks
Camera (HD)	Available	Functional
Microphone	Available	Clear audio
Lighting	Installed	Adjusted

Annexure-2: AV Consent Master Log

Subject ID	Study Code	Date	File Name	Stored Location
SUB001	BE-035	17/04/2025	BE035_SUB001_170425.mp4	Drive A/Site Folder

Annexure-3: AV Quality Review Log

Date Reviewed	Reviewed By	Subject IDs Reviewed	Remarks
30/04/2025	QA Reviewer	SUB001, SUB002	Clear audio and visibility

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial SOP	New CDSCO mandate	QA Head
17/04/2025	2.0	Added Annexures and enhanced AV compliance measures	Regulatory alignment	QA Head