Study Closure
Study Closure
Best practices after the completion of a study.
Fiscal Management
Approaching the end of grant term make sure all of your subcontracts that have been invoiced for their work are completed and received. Do not leave large encumbrances.
Maintenance and Storage of Research Records
Research records should be stored according to IRB requirements for at least three years after the completion of the research study or longer if required by the sponsor. FDA regulations state that study records must be stored for at least two years past the date of approval of a New Drug Application (NDA) or discontinuation of the research study if an NDA will not be submitted by the sponsor. It is important your study team keeps a log of where the records are stored, what is in each box and how they can be received for later staff members.
Many departments are contracted with Records Control (formerly Fireproof) and can be reached at 614-299-2122.