Standard Operating Procedures of the Institutional Review Board

VI. Closing Out a Study


Filing a closing report is an important element of the research study process. Besides informing the IRB that a study has concluded, it provides data on local subject ethnicity and gender, adverse events, and other information accumulated during the study. Federal guidelines require that terminated studies be reported to the FDA and OHRP, as well as to the sponsor and other institutional officials. The procedure for a closing reporting is very similar to that of continuing review. The same documentation required for continuing review is used. Data on subject recruitment, adverse events and other information must be provided when this final report is filed. Closing reports are reported to the Board.

 

For research projects approved as expedited or full IRB, close of the study should be reported at the conclusion of all study related activities. Once a study is closed, the file is withdrawn from the active IRB files and placed in archive for a minimum of three (3) years. The university is required to maintain files until a specified period of time has passed after completion of the study or project. Thus, it is essential that closing dates be provided to the IRB.