Study Assessment

Main Content

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 (Document Center - UMMC intranet log-in required).
  • 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