Final Project Reports
Description
The completion or termination of a study is a change in activity and must be reported to the IRB.
At the time a study is complete or discontinued, the investigator must submit a Final Project Report with the following information included:
- Total number of subjects
- Problems/complications and subject withdrawal, as applicable
- Study results, if available
Final Project Report Criteria
- The study is permanently closed to enrollment of new participants;
- You are no longer continuing to or planning to perform (for example, tests, physical or psychological exams, administer medications or treatments, etc.) on participants in order to gather data about them (including collection of data for follow-up);
- You are no longer continuing to or planning to interact (for example, letters, phone calls, interviews, re-contacting, etc.) with any participants in order to gather data about them;
- You are no longer continuing to or planning to gather any private identifiable information about participants.
- Data analysis is complete OR if you are continuing or planning to analyze data, the data does not contain participant identifiers or a link/code to identify study participants;
- If applicable, your sponsor/monitor has conducted the official close-out visit and will no longer require access to participant records or contact with the participants;
If applicable, documentation from the sponsor that all correspondence and queries related to the study have been addressed and the investigator's participation in the study is complete.
Note 1:
Please note that if the study does not expire (e.g. the study is Exempt, or the IRB has determined that CR is not required), a CR is not required to renew the IRB approval. A FPR should still be submitted when the study meets the FPR criteria noted above.
Note 2:
It is the PI's responsibility to handle the submission of information. This includes the submission of all applications pertaining to the study, as well as revisions requested during the IRB review of an application.
Administrative Study Closure
If the Principal Investigator has not completed study enrollment and/or procedures and the study expires, they must immediately cease enrollment and all other activities related to the study. If a continuing review application has not been submitted before the study expires, the study will be administratively closed. In order to continue with the study, a new study application must be submitted to the IRB. The investigator may not continue until they have received IRB approval to do so.