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Site Qualification

Definition

• Site qualification is the process by which the study sponsor and/or clinical research organization determine whether the investigator and the clinical site have the resources and capabilities necessary to conduct the study.
• The sponsor may require completion of a feasibility questionnaire. The Office of Clinical Trials can assist in completion of this and other sponsored-required information. 
• The sponsor may perform an on-site qualification visit to meet study personnel and view the site’s facilities.

Policies/guidelines

• If the sponsor decides to conduct an on campus visit, they must check-in with the Office of Integrity and Compliance upon arrival per UMMC’s External Auditor Policy.
• Topics of discussion during a site qualification visit
  • Investigator responsibilities
  • Qualifications of investigator and research team members
  • Study objectives, eligibility criteria, patient recruitment, and protocol-required procedures
  • Institutional Review Board and informed consent requirements
  • Adverse event reporting, source documentation, and record-keeping practices
  • Space requirements, storage requirements for study products, and availability of required equipment