Standard Operating Procedure for Recruiting and Screening Participants in Clinical Research

Purpose

The purpose of this SOP is to establish the process for recruiting and screening participants for clinical trials and clinical studies. This SOP ensures that the recruitment and screening process is conducted ethically and efficiently, in line with study requirements and regulatory standards.

Scope

This SOP applies to all personnel involved in participant recruitment and screening, including principal investigators, clinical research coordinators, and study team members.

Responsibilities

• Principal Investigator (PI): Oversees the recruitment and screening process and ensures ethical and regulatory compliance.
• Clinical Research Coordinators: Conduct participant recruitment and screening activities.
• Study Team: Assists in recruitment and screening, as needed.

Procedure

• Recruitment Plan Development:
  • Develop a recruitment plan based on the study protocol and inclusion/exclusion criteria.
  • Identify recruitment strategies, including advertising, referrals, and outreach activities.
  • Ensure recruitment materials are clear, accurate, and approved by the ethics committee.
• Participant Recruitment:
  • Execute recruitment strategies to reach potential participants.
  • Provide information about the study and answer questions from potential participants.
  • Schedule screening appointments for interested participants.
• Screening Process:
  • Conduct the screening process according to the study protocol.
  • Review participants’ medical history, medications, and eligibility criteria.
  • Perform any required tests or assessments to determine eligibility.
  • Document screening results and eligibility determinations.
• Enrollment and Documentation:
  • Obtain informed consent from eligible participants and provide study-related information.
  • Complete the enrollment process according to the study protocol.
  • Maintain records of recruitment and screening activities.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• ICF: Informed Consent Form

Documents

• Recruitment plan
• Recruitment materials (e.g., advertisements, flyers)
• Screening logs and forms
• Eligibility assessment forms
• Informed consent forms

References

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

SOP Version

Version: 1.0