Standard Operating Procedure for Compensating and Reimbursing Participants in Clinical Research

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 efforts and reimbursed for any study-related expenses in a consistent and ethical manner.

Scope

This SOP applies to all personnel involved in participant compensation and reimbursement in clinical trials and clinical studies, including principal investigators, clinical research coordinators, finance personnel, and other study team members.

Responsibilities

• Principal Investigator (PI): Oversees participant compensation and reimbursement policies, ensuring compliance with study budgets and protocols.
• Clinical Research Coordinators: Communicate compensation and reimbursement policies to participants and facilitate payments.
• Finance Personnel: Manage the financial aspects of participant compensation and reimbursement according to institutional policies and regulatory requirements.
• Participants: Provide accurate information for reimbursement and compensation purposes and adhere to the study schedule and requirements.

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 and ensure they understand the process.
• Tracking Participant Participation:
  • Maintain accurate records of participant attendance and completion of study visits and procedures.
  • Record study-related expenses incurred by participants, such as travel, accommodation, and other out-of-pocket expenses.
• Processing Compensation and Reimbursement:
  • Process participant payments according to the study budget and institutional policies.
  • Reimburse participants for study-related expenses upon submission of valid receipts or other required documentation.
  • Ensure payments and reimbursements are made in a timely manner to maintain participant trust and engagement.
• 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