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“headline”: “SOP for Subject Compensation and Reimbursement Handling in Clinical Trials”,
“description”: “This SOP defines standardized procedures for subject compensation and reimbursement handling in clinical trials, ensuring ethical compliance, transparency, and adherence to ICH GCP, FDA, EMA, CDSCO, and WHO regulations.”,
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Published on 22/12/2025
Standard Operating Procedure for Subject Compensation and Reimbursement Handling
| Department | Clinical Research |
| SOP No. | CR/SUB/030/2025 |
| Supersedes | NA |
| Page No. | 1 of 22 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define standardized procedures for subject compensation and reimbursement handling in clinical trials. It ensures ethical, transparent, and compliant financial practices that safeguard
Scope
This SOP applies to investigators, study coordinators, site administrators, sponsors, and CROs responsible for handling subject compensation and reimbursement. It covers allowances for travel, meals, lodging, and stipends approved by Ethics Committees (EC) or Institutional Review Boards (IRB).
Responsibilities
- Principal Investigator (PI): Ensures no payments are made without prior EC/IRB approval.
- Study Coordinator: Maintains subject reimbursement logs and collects supporting documentation.
- Finance/Administration Staff: Issues payments in line with approved procedures.
- Sponsor/CRO: Oversees financial compliance and reimbursement to sites.
- Quality Assurance Officer: Audits payment records during monitoring and inspections.
Accountability
The PI is accountable for ensuring that subject compensation and reimbursement are consistent with approved guidelines and are fully documented. Sponsors are accountable for oversight of financial practices across sites.
Procedure
1. Approval of Compensation
Ensure all compensation schemes are reviewed and approved by EC/IRB before initiation.
Document approvals in Compensation Approval Log (Annexure-1).
2. Communication to Subjects
Inform participants about compensation and reimbursement policies during the informed consent process.
Provide written details on payment schedules and conditions.
3. Documentation
Record all compensation and reimbursements in Subject Compensation Log (Annexure-2).
Obtain subject signatures for all payments.
4. Methods of Payment
Payments may be made in cash, bank transfer, or vouchers as per site policy.
Maintain confidentiality of participant financial records.
5. Monitoring
Sponsor monitors ensure compliance with approved compensation practices.
Any deviations are documented in CAPA Log (Annexure-3).
6. Archiving
File compensation and reimbursement records in ISF and TMF.
Retain documents for a minimum of 5 years post-trial or as per national regulations.
Abbreviations
- SOP: Standard Operating Procedure
- PI: Principal Investigator
- CRO: Clinical Research Organization
- EC: Ethics Committee
- IRB: Institutional Review Board
- ISF: Investigator Site File
- TMF: Trial Master File
- CAPA: Corrective and Preventive Actions
Documents
- Compensation Approval Log (Annexure-1)
- Subject Compensation Log (Annexure-2)
- CAPA Log for Compensation Deviations (Annexure-3)
References
- ICH E6(R2) – Good Clinical Practice
- US FDA – Clinical Trial Guidance
- EMA Clinical Trial Regulation
- CDSCO Clinical Trial Rules, 2019
- WHO – Clinical Research Ethics and Compensation Guidance
Version: 1.0
Approval Section
| Prepared By | Rajesh Kumar, Clinical Research Coordinator |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Principal Investigator |
Annexures
Annexure-1: Compensation Approval Log
| Date | Approval Reference | Compensation Type | Approved By |
|---|---|---|---|
| 10/09/2025 | EC/APP/030 | Travel Reimbursement | EC Chairperson |
Annexure-2: Subject Compensation Log
| Date | Subject ID | Compensation Type | Amount | Signature |
|---|---|---|---|---|
| 12/09/2025 | CT2025-SITE01-032 | Meal Allowance | ₹500 | Signed |
Annexure-3: CAPA Log for Compensation Deviations
| Date | Issue | Corrective Action | Preventive Action | Reviewed By |
|---|---|---|---|---|
| 14/09/2025 | Delayed Payment | Processed within 48 hrs | Set automated reminders | QA Officer |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head, Clinical Research |
For more SOPs visit: Pharma SOP