Standard Operating Procedure for Addressing Participant Feedback and Issues in Clinical Research

Purpose

This SOP outlines the procedures for receiving, investigating, and resolving participant complaints and concerns in clinical trials and clinical studies. The goal is to ensure participants feel heard and supported, maintain trust in the research process, and promote ethical and high-quality studies.

Scope

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

Responsibilities

• Principal Investigator (PI): Oversees the complaint resolution process and ensures appropriate follow-up with participants.
• Clinical Research Coordinators: Serve as primary points of contact for participant complaints and concerns, and facilitate resolution.
• Study Team Members: Escalate participant complaints and concerns to the PI or study coordinator for resolution as needed.

Procedure

• Receiving Complaints and Concerns:
  • Provide participants with clear channels for submitting complaints and concerns (e.g., phone, email, in-person meetings).
  • Acknowledge receipt of complaints and concerns promptly, ideally within 24 hours.
• Investigation and Resolution:
  • Conduct a thorough investigation of participant complaints and concerns, gathering relevant information and consulting with involved parties.
  • Maintain participant confidentiality during the investigation and resolution process.
  • Develop and implement a plan to resolve the issue, ensuring participant satisfaction and compliance with study protocols and regulations.
  • Communicate the resolution plan to the participant and follow up to ensure their concerns have been addressed.
• Documentation:
  • Document all participant complaints and concerns, including details of the complaint, the investigation process, and the resolution.
  • Maintain records of complaints and resolutions for auditing and regulatory compliance purposes.
• Training and Education:
  • Provide training to study personnel on how to handle participant complaints and concerns with empathy and professionalism.
  • Offer ongoing education on best practices for addressing participant feedback and issues.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Complaint and concern logs
• Investigation and resolution reports
• Follow-up communication records
• Training materials

References

• Institutional policies for handling complaints and concerns
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)

SOP Version

Version: 1.0