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