Standard Operating Procedure for Volunteer Compensation and Reimbursement in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/085/2025
Supersedes	SOP/BA-BE/085/2022
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 standardized procedure for providing compensation and reimbursement to volunteers who participate in Bioavailability/Bioequivalence (BA/BE) studies in compliance with ethical standards and applicable regulatory requirements.

2. Scope

This SOP applies to the finance, clinical, and administrative staff involved in the calculation, approval, documentation, and disbursement of compensation to study volunteers across all BA/BE studies conducted at the clinical site.

3. Responsibilities

• Finance Department: Calculates and processes payment according to approved budget and study plan.
• CRC: Maintains subject participation records and verifies completion status for eligibility.
• Investigator: Approves compensation disbursement and verifies absence of protocol violations.

4. Accountability

The Study Director is accountable for ensuring volunteers receive compensation as approved by the Ethics Committee, in a timely and transparent manner.

5. Procedure

5.1 Determination of Compensation

1. Compensation is based on:
   • Ethics Committee approved amount
   • Duration of stay and study participation
   • Study-related inconvenience or risk
2. Reimbursement includes:
   • Travel expenses
   • Meal coupons or actual meal costs

5.2 Eligibility Criteria

1. Volunteers who complete the study period without major protocol violations are eligible.
2. Partial compensation may be given in case of withdrawal due to medical reasons or investigator discretion.

5.3 Approval Process

1. CRC verifies subject ID and completion of all protocol activities.
2. Prepare Annexure-1: Compensation Approval Sheet and get PI sign-off.
3. Finance department reviews and disburses payments accordingly.

5.4 Disbursement

1. Payments shall be made:
   • By cheque, direct bank transfer, or UPI
   • In the presence of a witness (when in cash)
2. Documented in Annexure-2: Volunteer Payment Register signed by recipient.

5.5 Handling Discrepancies

1. Any payment discrepancy or dispute must be recorded in Annexure-3: Compensation Discrepancy Log and resolved within 5 working days.

5.6 Confidentiality and Recordkeeping

1. Volunteer financial information shall be maintained confidentially in secure files.
2. Retention period for records shall be at least 5 years or as per sponsor/regulatory requirements.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• EC: Ethics Committee
• PI: Principal Investigator

7. Documents

1. Compensation Approval Sheet – Annexure-1
2. Volunteer Payment Register – Annexure-2
3. Compensation Discrepancy Log – Annexure-3

8. References

• Indian GCP Guidelines
• ICH E6(R2) Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Compensation Approval Sheet

Subject ID	Study Code	Amount Approved (₹)	Approved By (PI)	Date
VOL-085	BE/2025/003	7,500	Dr. Arvind Shah	17/04/2025

Annexure-2: Volunteer Payment Register

Subject ID	Payment Mode	Amount Paid	Paid By	Signature
VOL-085	UPI	₹7,500	Sunita Reddy	Rajesh Kumar

Annexure-3: Compensation Discrepancy Log

Date	Subject ID	Issue	Resolution	Handled By
17/04/2025	VOL-085	Bank details mismatch	Paid in cash with witness	CRC

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial SOP Release	EC Approved Process	QA Head
17/04/2025	2.0	Included Annexures for Transparency and UPI mode	Operational Update	QA Head