Status Report Form (for Periodic reporting and renewal) *   **

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Periodic (Status) Review

To facilitate the Board's determination of whether changes have occurred in the risk/benefit estimation, the IRB requires reports from investigators at the midpoint of the study approval period. Investigators should use the Periodic Report form to guide their submission of information. Goodwyn IRB staff will notify investigators when it is time to submit a periodic report.

Renewal Application

IRB approval for each study is for a defined period of time, not to exceed one year. The approval period for each study is determined by Goodwyn IRB at the time of original review of the study, and is based upon the nature of the study, the degree of risk, and the vulnerability of the population.

If conduct of a trial or research study is to extend beyond the approval period, Goodwyn IRB requires investigators to submit a renewal application for review. Investigators should use the Renewal Application form to guide their submission.

Before the investigator's approval is due to expire, Goodwyn IRB staff will notify the investigator that the study is due for renewal, along with instructions for submitting the renewal application and form.