Standard Operating Procedure for Ensuring Participant Follow-Up and Retention in Clinical Research

Purpose

This SOP outlines the procedures for conducting follow-up with participants and ensuring their retention in clinical trials and clinical studies. The goal is to maintain high levels of participant engagement, adherence, and retention to support study integrity and data quality.

Scope

This SOP applies to all personnel involved in participant follow-up and retention in clinical trials and clinical studies, including principal investigators, clinical research coordinators, study nurses, and other study team members.

Responsibilities

• Principal Investigator (PI): Oversees participant follow-up and retention processes and ensures compliance with study protocols and regulations.
• Clinical Research Coordinators: Coordinate and conduct participant follow-up visits and maintain communication with participants.
• Study Nurses and Medical Personnel: Conduct participant assessments and provide medical care as needed during follow-up visits.
• Data Management Team: Manage data collection and documentation during follow-up visits and participant interactions.

Procedure

• Scheduling Follow-Up Visits:
  • Schedule follow-up visits according to the study protocol and participant availability.
  • Provide participants with advance notice and reminders about upcoming visits.
• Conducting Follow-Up Visits:
  • Perform assessments and collect data according to the study protocol during follow-up visits.
  • Address participant questions and concerns during visits to maintain engagement.
  • Monitor participant adherence to the study regimen and provide support as needed.
• Communication and Engagement:
  • Maintain regular communication with participants through various channels (e.g., phone, email, text).
  • Provide participants with study updates and information to keep them informed and engaged.
  • Offer support and resources to address participant concerns and maintain their commitment to the study.
• Retention Strategies:
  • Develop and implement strategies to enhance participant retention (e.g., incentives, transportation assistance).
  • Monitor participant retention rates and identify factors affecting retention.
  • Take proactive measures to address retention challenges and improve participant engagement.
• Documentation and Reporting:
  • Document follow-up visits, assessments, and participant interactions accurately and promptly.
  • Track and report participant retention rates and follow-up outcomes.
• Training and Education:
  • Provide training to study personnel on follow-up and retention processes and best practices.
  • Offer ongoing education and support to ensure adherence to follow-up and retention protocols.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Follow-up visit schedules and reminders
• Participant assessments and data collection forms
• Communication logs and participant interactions
• Retention reports and monitoring logs
• Training materials

References

• Institutional policies for participant follow-up and retention
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Study protocols and investigator brochures

SOP Version

Version: 1.0