Standard Operating Procedure for Informed Consent Process Execution in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/054/2025
Supersedes	SOP/BA-BE/054/2022
Page No.	Page 1 of 11
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To outline the procedure for obtaining and documenting informed consent from healthy volunteers prior to participation in any Bioavailability/Bioequivalence (BA/BE) study-related procedures, in accordance with ICH-GCP, Schedule Y, and ethical standards.

2. Scope

This SOP applies to all clinical staff involved in conducting the informed consent process in BA/BE studies at the clinical site, including pre-screening, screening, and study enrolment phases.

3. Responsibilities

• Investigator/Sub-Investigator: Explains study details to the volunteer and answers all questions.
• Clinical Research Coordinator: Assists in organizing the consent session, ensures correct version of ICF is used, and witnesses the consent process.
• Quality Assurance: Verifies that consent documents are complete, accurate, and archived.

4. Accountability

The Principal Investigator is accountable for ensuring that no study-related procedures begin before valid informed consent is obtained and documented.

5. Procedure

5.1 Preparation for Consent Process

1. Use only Ethics Committee (EC)-approved and current version of the Informed Consent Form (ICF).
2. Ensure ICF is available in both English and vernacular languages understood by the volunteer.
3. Arrange a quiet and private area for the discussion.

5.2 Conduct of Consent Discussion

1. Investigator/Sub-Investigator explains the study objective, procedures, risks, benefits, compensation, and the right to withdraw at any time.
2. Use Annexure-1: Informed Consent Checklist to ensure all elements are covered.
3. Encourage the volunteer to ask questions and provide adequate time to decide.

5.3 Obtaining and Documenting Consent

1. After volunteer agrees, obtain signature/thumb impression on the ICF along with date and time.
2. Ensure the signature of an impartial witness is obtained for illiterate volunteers.
3. Provide a copy of the signed ICF to the volunteer.
4. Document the entire process in Annexure-2: Informed Consent Documentation Form.

5.4 Special Considerations

1. For AV consent (if applicable), ensure proper camera angle, identity confirmation, and clear audio-video recording.
2. Store the AV file securely with restricted access.

5.5 Post-Consent Actions

1. File the original signed ICF in the subject’s screening folder.
2. Update the Informed Consent Log (Annexure-3) for each subject enrolled.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• ICF: Informed Consent Form
• EC: Ethics Committee
• PI: Principal Investigator
• AV: Audio-Visual

7. Documents

1. Informed Consent Checklist – Annexure-1
2. Informed Consent Documentation Form – Annexure-2
3. Informed Consent Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• CDSCO Guidelines for Audio-Visual 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: Informed Consent Checklist

Item	Explained (Yes/No)	Remarks
Study Purpose	Yes	Explained in Hindi
Risk and Benefits	Yes	Volunteer acknowledged

Annexure-2: Informed Consent Documentation Form

Subject ID	Date	Investigator	Witness Name	Copy Given
VOL-054	16/04/2025	Dr. Arvind Shah	Rahul Patil	Yes

Annexure-3: Informed Consent Log

Subject ID	ICF Version	Date Signed	Investigator	Remarks
VOL-054	v1.1	16/04/2025	Dr. Arvind Shah	Consent completed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial version	Implementation	QA Head
17/04/2025	2.0	Added AV consent process and annexures	Compliance with CDSCO requirements	QA Head