Final Project Reports
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:
- Total number of subjects
- Amendments since last approval
- Problems/complications and subject withdrawal, as applicable
- Study results, if available
- Sponsor/accounting information
When to Submit a Final Project Report
A Final Project Report should only be submitted when all the following criteria are met:
- Research is permanently closed to the enrollment of new participants.
- All participants have completed research interventions (e.g., tests, physical or psychological exams, administer medications or treatments, etc.) including collection of data for follow-up.
- When individually identifiable data are no longer being collected on subjects (e.g., letters, phone calls, interviews, re-contacting, etc.)
- Data analysis indicates no new information needs to be provided to enrolled participants
- There is no need to re-contact enrolled subjects to obtain additional research information
- Data analysis is completed or is continuing on only de-identified data.
Multi-site industry studies must meet the above criteria as well as the following:
- 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; and
- Study close-out (termination) visits have been completed, if applicable
If these criteria are not met, the investigator must apply for continuing review to allow for continued research activities. If the study is closed before these criteria are met, a new study application must be submitted before continuing with research activities. The investigator may not conduct research activities until he/she has received IRB approval to do so.
Submitting a Final Project Report in ERICA
- Open the study.
- Click on the Continuing Reviews tab.
- Click on the Create button.
- Answer the questions on the first page. Keep in mind that your answers must align
with the criteria mentioned above in order for the application to take you to the
Final Project Report.
See further instructions about completing this first page [PDF].
- Answer "Yes" on the Final Project Report page.
- Complete the remaining pages of the final project report entirely.
- Submit the final project report to the IRB for review.
Note: 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, he/she 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 he/she has received IRB approval to do so.