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Standard Operating Procedure for Audio-Visual Recording of Consent in Clinical Trials

Purpose

The purpose of this SOP is to describe the procedure for conducting and documenting audio-visual (AV) recordings of the informed consent process for clinical trial participants, where mandated by law, regulatory authority, or trial protocol. AV recording enhances transparency, ensures participant comprehension, and provides verifiable documentation for regulatory inspections.

Scope

This SOP applies to all investigators, sub-investigators, site staff, and regulatory personnel responsible for obtaining and recording informed consent in trials requiring AV documentation. It is applicable in jurisdictions such as India (as per CDSCO), and in global trials where protocol or sponsor requires AV recording.

Responsibilities

• Principal Investigator (PI): Ensures compliance with AV consent requirements, equipment availability, and secure storage of recordings.
• Study Coordinator: Operates recording equipment, ensures data quality, and maintains logs.
• Participant: Provides explicit consent for AV recording prior to initiation of the process.
• IT/Data Manager: Ensures secure storage, restricted access, and backup of AV recordings.
• Quality Assurance Officer: Audits AV consent records during monitoring or inspection.

Accountability

The Principal Investigator is accountable for ensuring that AV recording of informed consent is performed ethically, securely, and in line with applicable regulatory requirements. Non-compliance can result in trial suspension or regulatory action.

Procedure

1. Preparation
Confirm legal/protocol requirements for AV recording before trial initiation.
Obtain EC/IRB approval for AV consent procedure and participant information sheet.
Prepare recording equipment (camera, microphone, backup systems).

2. Participant Permission
Before recording, explain to participants that AV recording is mandatory for documentation purposes.
Obtain explicit consent for AV recording, separate from trial participation consent.
Provide option to withdraw prior to recording.

3. Conducting the AV Recording
Record the entire consent discussion, including explanation of study, risks, benefits, and participant questions.
Ensure presence of impartial witness for illiterate participants.
Capture participant, investigator, and witness (if any) in the recording.

4. Documentation
Maintain AV Recording Log with date, participant ID, and investigator details.
Link AV recordings to participant records in Trial Master File (TMF).

5. Storage and Security
Store recordings in encrypted format with restricted access.
Maintain backups in secure servers.
Retain recordings for minimum 5 years post-trial or longer as per local laws.

6. Inspection and Review
Provide recordings to regulatory inspectors upon request.
Do not share recordings outside authorized personnel.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• AV: Audio-Visual
• EC: Ethics Committee
• IRB: Institutional Review Board
• QA: Quality Assurance
• TMF: Trial Master File

Documents

1. AV Recording Log (Annexure-1)
2. Participant AV Recording Consent Form (Annexure-2)
3. AV Recording Equipment Checklist (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Informed Consent Regulations
• EMA Clinical Trial Regulation (EU No. 536/2014)
• CDSCO – Audio-Visual Consent Guidelines
• WHO – Guidance on Ethics in Health Research

Version: 1.0

Approval Section

Annexures

Annexure-1: AV Recording Log

Annexure-2: Participant AV Recording Consent Form

Annexure-3: AV Recording Equipment Checklist

Revision History

For more SOPs visit: Pharma SOP