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
- Compensation is based on:
- Ethics Committee approved amount
- Duration of stay and study participation
- Study-related inconvenience or risk
- Reimbursement includes:
- Travel expenses
- Meal coupons or actual meal costs
5.2 Eligibility Criteria
- Volunteers who complete the study period without major protocol violations are eligible.
- Partial compensation may be given in case of withdrawal due to medical reasons or investigator discretion.
5.3 Approval Process
- CRC verifies subject ID and completion of all protocol activities.
- Prepare Annexure-1: Compensation Approval Sheet and get PI sign-off.
- Finance department reviews and disburses payments accordingly.
5.4 Disbursement
- Payments shall be made:
- By cheque, direct bank transfer, or UPI
- In the presence of a witness (when in cash)
- Documented in Annexure-2: Volunteer Payment Register signed by recipient.
5.5 Handling Discrepancies
- 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
- Volunteer financial information shall be maintained confidentially in secure files.
- 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
- Compensation Approval Sheet – Annexure-1
- Volunteer Payment Register – Annexure-2
- 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 |