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Study Close-Out Visit SOP Considerations

If you are developing an SOP for a study close-out visit, you should consider the following:

  • The Principal Investigator or his/her designee will schedule and arrange the closeout visit as requested by the sponsor representative. Attendees will include all pertinent staff (if available). 
  • Close-out visits will be scheduled at mutually convenient time and every attempt will be made to accommodate monitoring deadline.
  • Prior to the visit, the Investigator designee will confirm with the sponsor representative what materials will be reviewed so that appropriate documentation and files will be made readily available. These materials may include:
  • Subject source documents and corresponding case report forms
  • (CRFs)Investigator Site File
  • Safety reports and/or Adverse event documentation
  • Access to investigational product (IP) storage and accountability documentation.
  • The Principal Investigator-designee will make sure that an appropriate work area is available for the monitoring visit. The work area will include:
    • Quiet location
    • Phone access
    • Internet access
    • Copy machine access
    • Desk and chair
    • Data ports for computers (if necessary)  
  • The Investigator designee will schedule time to work with monitor during the visit to review and complete any data clarifications as necessary.
  • The Principal Investigator’s authorized staff will arrange for sponsor review of accountability, reconciliation and final disposition. All unused or returned IP will be returned to the sponsor (either shipped or picked up) for final disposition unless other written sponsor procedures.
  • Case report forms (CRFs) and study related documents will be submitted to the sponsor according to sponsor SOPs.  All documents will only include the subjects study number for identification.
  • Issues of record retention, publication policies will be discussed/resolved at this meeting.
  • The IRB will be notified of study closure using the Institutional Review Board (IRB) Final Progress Report.
  • The report will be sent to the IRB according to IRB Final Progress Report guidelines.
  • The research records will be prepared for storage.  A study document storage tracking list will be prepared with one copy kept with records and one at the site.