Standard Operating Procedure for Compensating and Reimbursing Clinical Trial Participants

Purpose

This SOP outlines the procedures for compensating and reimbursing participants in clinical trials and clinical studies. The goal is to ensure participants are fairly compensated for their time and effort and reimbursed for any study-related expenses in a timely manner.

Scope

This SOP applies to all personnel involved in the financial aspects of clinical trials and clinical studies, including principal investigators, clinical research coordinators, and finance personnel.

Responsibilities

• Principal Investigator (PI): Oversees participant compensation and reimbursement policies and ensures compliance with study budgets and protocols.
• Clinical Research Coordinators: Inform participants about the compensation and reimbursement process and facilitate payments.
• Finance Personnel: Manage the financial aspects of participant compensation and reimbursement according to institutional policies.

Procedure

• Establishing Compensation and Reimbursement Policies:
  • Determine appropriate compensation rates and reimbursement amounts for participants based on the study protocol and institutional guidelines.
  • Communicate compensation and reimbursement policies to participants during the informed consent process.
• Tracking Participant Participation:
  • Maintain accurate records of participant attendance and completion of study visits and procedures.
  • Track study-related expenses incurred by participants, such as travel and accommodation costs.
• Processing Compensation and Reimbursement:
  • Process participant payments according to the study budget and institutional policies.
  • Reimburse participants for study-related expenses upon submission of receipts or other required documentation.
  • Ensure payments and reimbursements are made in a timely manner.
• Communication with Participants:
  • Inform participants of the payment and reimbursement process, including payment methods and timelines.
  • Address participant questions or concerns about compensation and reimbursement promptly and courteously.
• Record-Keeping and Compliance:
  • Maintain detailed records of participant payments and reimbursements, including amounts, dates, and methods of payment.
  • Ensure compliance with institutional policies, study budgets, and regulatory requirements regarding compensation and reimbursement.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Study budgets and financial records
• Participant attendance and expense records
• Compensation and reimbursement policies and guidelines

References

• Institutional policies and procedures
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)

SOP Version

Version: 1.0