Checklist |
There are a plethora of activities that need to be conducted by the investigator and study team during the study closeout phase that involve: data management, adverse events reporting/reconciliation, review of site files, review for completeness of the various study logs and documents, management of remaining investigational product, review of collected laboratory specimens, analysis of the study data, manuscript preparation and submission and more. A Study Closeout Checklist can be accessed and modified to meet the needs of a particular study. |