Standard Operating Procedure for Clinical Trial Photography and Video Recording in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/109/2025
Supersedes	SOP/BA-BE/109/2022
Page No.	Page 1 of 9
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish a controlled and ethical procedure for capturing and managing photographic and video documentation during Bioequivalence (BE) studies in accordance with regulatory and ethical standards.

2. Scope

This SOP is applicable to all personnel involved in video recording or photography of informed consent processes, subject activities, dosing, or facility operations during BE studies.

3. Responsibilities

• Clinical Research Coordinator (CRC): Coordinates and verifies audiovisual documentation and consent.
• Investigator: Ensures recordings are conducted ethically and maintains participant rights and safety.
• QA Officer: Reviews audiovisual files for compliance and retention.
• IT/Data Manager: Maintains secure storage, access control, and backup of recorded files.

4. Accountability

The Principal Investigator is accountable for ensuring that all audio-visual recordings are captured, stored, and accessed in accordance with ICH-GCP and Indian regulations.

5. Procedure

5.1 Consent for Photography and Video Recording

1. Inform all participants about the purpose and scope of photography/video recording.
2. Obtain separate, signed audiovisual consent using Annexure-1: AV Consent Form.
3. Do not proceed with recording unless explicit consent is provided.

5.2 Recording Requirements

1. Use approved, secure recording devices only.
2. Ensure camera captures:
   • Full view of volunteer and investigator during consent discussion
   • Clear audio and video quality
3. Recordings shall include:
   • Date and time stamp
   • Protocol title or number
   • Volunteer ID only (no full names)

5.3 Data Handling and Security

1. Store recordings in encrypted, access-restricted folders.
2. Label files using study ID, volunteer ID, and date (e.g., BE123_VOL109_170425).
3. Maintain access logs (Annexure-2) for all view/download actions.

5.4 Retention and Backup

1. Retain audiovisual recordings for at least 5 years or as per sponsor agreement.
2. Back up recordings on a secure server or external encrypted device monthly.

5.5 Use and Disclosure

1. Use recordings solely for study documentation, audit, or regulatory review.
2. Any external use (e.g., training, publication) requires additional written consent from the subject.

5.6 Incident Management

1. In case of:
   • Recording failure
   • Missing consent
   • Unauthorized access
2. Document in Annexure-3: Recording Incident Log and initiate CAPA if needed.

6. Abbreviations

• BE: Bioequivalence
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• AV: Audio-Visual
• CAPA: Corrective and Preventive Action

7. Documents

1. AV Consent Form – Annexure-1
2. Recording Access Log – Annexure-2
3. Recording Incident Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Indian GCP Guidelines
• Schedule Y – Drugs and Cosmetics Rules
• CDSCO Guidance on AV Recording of Informed Consent

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 Form

Volunteer ID	Consent Given	Signature	Date	Witness Name
VOL-109-004	Yes	Signed	16/04/2025	Sunita Reddy

Annexure-2: Recording Access Log

Date	Accessed By	Role	Purpose	Signature
17/04/2025	Ajay Verma	QA	Audit Review	Signed

Annexure-3: Recording Incident Log

Date	Incident Description	Reported By	CAPA Initiated	Verified By
15/04/2025	Mic issue in AV recording	CRC	Yes	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP	Ethical Requirement	QA Head
17/04/2025	2.0	Added annexures, access log, backup requirements	Audit Observation	QA Head