Standard Operating Procedure for Selecting and Initiating Clinical Research Sites

Purpose

The purpose of this SOP is to establish the process for selecting and initiating clinical research sites in order to ensure the success of clinical trials and clinical studies. This SOP ensures that sites are capable of conducting studies according to the study protocol, ethical standards, and regulatory requirements.

Scope

This SOP applies to all personnel involved in the selection and initiation of clinical research sites, including principal investigators, clinical research coordinators, study managers, and sponsors.

Responsibilities

• Sponsor: Leads the site selection process and provides support during site initiation.
• Principal Investigator (PI): Provides oversight and leadership during site initiation and ongoing operations.
• Site Selection Team: Conducts site feasibility assessments and site visits.
• Regulatory Affairs: Ensures site compliance with regulatory requirements during selection and initiation.
• Clinical Research Coordinators: Provide support during site initiation and ongoing site operations.

Procedure

• Site Selection:
  • Identify potential sites based on study requirements, investigator expertise, and patient population.
  • Conduct a site feasibility assessment, including site infrastructure, resources, and prior research experience.
  • Evaluate the site’s adherence to ethical and regulatory standards.
  • Perform a site visit to assess site readiness and meet with the site staff.
  • Select sites based on the assessment results and establish agreements with the chosen sites.
• Site Initiation:
  • Provide training to site staff on the study protocol, procedures, and regulatory requirements.
  • Ensure the site has all necessary study materials, including protocols, case report forms, and consent forms.
  • Conduct a site initiation visit to review study logistics and ensure readiness for study launch.
  • Establish communication and reporting channels between the site and the study team.
  • Monitor the site’s progress and address any issues or concerns promptly.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• FDA: Food and Drug Administration
• EMA: European Medicines Agency
• IRB: Institutional Review Board

Documents

• Site feasibility assessment forms
• Site visit reports
• Site initiation checklists
• Site agreements and contracts
• Study protocol, case report forms, and informed consent forms

References

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

SOP Version

Version: 1.0