Clinical Studies

SOP for Participant Recruitment and Screening

Standard Operating Procedure for Recruiting and Screening Participants in Clinical Research

Purpose

This SOP outlines the procedures for recruiting and screening participants in clinical trials and clinical studies. The goal is to ensure that recruitment and screening are conducted efficiently, ethically, and in compliance with study protocols and regulatory requirements.

Scope

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

Responsibilities

  • Principal Investigator (PI): Provides oversight and ensures ethical recruitment and screening practices.
  • Clinical Research Coordinators: Conduct recruitment and screening activities in accordance with study protocols.
  • Study Team: Assists in recruitment and screening as required by the study protocol.
See also  SOP for Maintenance of Regulatory Documents

Procedure

  • Recruitment Plan:
    • Develop a recruitment plan based on the study protocol, including inclusion and exclusion criteria.
    • Define recruitment strategies such as advertising, referrals, and outreach programs.
    • Ensure recruitment materials are accurate, clear, and approved by the ethics committee.
  • Participant Recruitment:
    • Execute recruitment strategies to attract potential participants.
    • Provide information about the study and answer questions from potential participants.
    • Schedule screening appointments for interested participants.
  • Screening Process:
    • Conduct screening according to the study protocol and inclusion/exclusion criteria.
    • Review participant medical history, medications, and perform required assessments.
    • Document screening results, including eligibility determinations.
  • Enrollment:
    • Obtain informed consent from eligible participants.
    • Complete enrollment and begin the study according to the protocol.
    • Maintain records of recruitment and screening activities.
See also  SOP for Interim Analysis and Data Monitoring Committees

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

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