Study Close-Out

  • schedule and prepare for close-out monitoring visit.
  • return or dispose of unused supplies per sponsor requirements.
  • ensure all queries and resolutions are addressed before database lock.
  • reconcile test article accountability.
  • conduct audit on documents and pertinent files and prepare for storage.
  • document patients who were lost to follow-up or who had dropped out (e.g., causes, contact efforts).
  • back-up disks of all electronic data to be included with storage files.
  • document location and store study records according to sponsor and FDA guidelines.
  • prepare for and respond to sponsor or FDA audits.
    perform study analyses and prepare reports and presentations when warranted or requested