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Standard Operating Procedure for Subject Compensation and Reimbursement Handling

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 participant welfare and maintain trust in the research process.

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

1. Compensation Approval Log (Annexure-1)
2. Subject Compensation Log (Annexure-2)
3. 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

Annexures

Annexure-1: Compensation Approval Log

Annexure-2: Subject Compensation Log

Annexure-3: CAPA Log for Compensation Deviations

Revision History

For more SOPs visit: Pharma SOP