Study Closeout & Analysis
The purpose of the Closeout and Analysis stop is to complete all necessary tasks to formally end the trial.
Description
Following completion of patient assessments, several close out activities occur.
- Study medication is returned to the sponsor or CRO, reconciled and destroyed.
- Research sites are closed, following a final review of all data collected, and regulatory document status.
- Vendor activities are completed and data collected is verified, cleaned and stored.
- Final data cleaning activities are conducted across all data collected. Statistical analyses and results are generated.
- Completing study reports: This includes writing a final report that summarizes the results of the trial, as well as a safety report that summarizes any adverse events that occurred during the trial.
- Submitting study reports to regulatory agencies: This may involve submitting the reports to the FDA, the EMA, or other regulatory bodies.
DCT-specific Considerations/Inputs
- Final site monitoring and closure: Consider how to manage these processes for non-traditional research sites (e.g. pharmacies, mobile research units, etc). What needs to be done may be very similar. Where it's done may be different.
- Return of clinical trial supplies and study medication: If direct to patient shipping was used, create a clear plan to communicate with patients what needs to be returned and where. These instructions may also apply if the patient received a wearable or other devices at a research site and used them to participate in the trial remotely.
- In alignment with the patient-centric design of DCTs, communicating trial progress and results is a possibility.
- Depending on the consent patients gave as part of trial participation, patient profiles may need to be deleted at study close.