Chapter 13 - Study Closure or Termination

What is the most common reason for a study to be concluded at a site?

The site enrolled subjects and they have finished, the data has been monitored and queries resolved.

What should be included in the Investigator’s Study File / eTMF?

Investigational Product return inventory form (when returning IP to the Sponsor), IRB re-approvals, IRB correspondence, all versions of the Protocol, all versions of the Informed Consent Form, Informed Consent Forms for all subjects, documentation for all Protocol deviations, Investigator’s Brochure.

Who must the Investigator notify of impending study closure.

The IRB.

What is a “final study report”?

A report by the Investigator that includes information like enrollment summaries, serious adverse events, and major deviations

Who must the Investigator provide the “final study report” to?

The IRB and the Sponsor.

Records Retention: How long must the site keep records for?

Records must be kept for two years after the NDA is approved for marketing or, if an NDA is not filed or is disapproved, for two years after the investigation is discontinued and the FDA notified.

True or False: Most sponsors expect the investigator to retain all study records until notified by the sponsor that they may be disposed of; this will usually be in the contract the investigator signed before starting the study.

True.

What is an Annual Storage Fee?

A fee paid by Sponsor to site negotiated with the overall study grant (at the start of the study) or at the end of the study. Includes record retention.

Changes in document storage after study closure: Who must the site notify of the new location?

The site must notify the Sponsor.