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Final Project Reports

At the time a study is complete or discontinued, the investigator must submit a Final Project Report with the following:

1. Total number of subjects
2. Amendments since last approval
3. Problems/complications and subject withdrawal
4. Study results
5. Sponsor/accounting information

When to Submit a Final Project Report

A Final Project Report should only be submitted if all the following criteria are met:

• The study is closed to enrollment
• The researchers will no longer be performing or planning to perform interventions (e.g., tests, physical or psychological exams, administer medications or treatments, etc.) on subjects in order to gather data about them.
• The researchers will no longer interact with any subjects (e.g., letters, phone calls, interviews, re-contacting, etc.) in order to gather data about them.
• The researchers will no longer gather any private identifiable information about subjects (e.g., chart reviews, receipt of information from health care entities, etc.)
• The study sponsor/monitor (if applicable) has conducted their official close-out visit and will no longer request access to patients’ records or contact with a participant

If these criteria are not met, the study should be renewed to allow for further research activities. If the study is closed before these criteria are met, a new study application must be submitted to continue with research activities. The investigator may not continue 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.
  Click HERE for further instructions about completing this first page.
• 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.

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.