The completion of a research project is considered a change in activity and must be reported to the IRB. A final report allows the IRB to close its file as well as providing information that may be used by the IRB in the evaluation and approval of related studies. Projects are considered finally closed when all research activities have been completed such as subject follow-up and data analysis specific to the aims and goals of the project. The IRB will keep the project’s records for at least three (3) years after the date of closure.
The investigator must submit to the IRB a final study closure report. The information will be reviewed and the convened IRB will be notified.