CONTINUING REVIEW

Federal regulations require that, at a minimum, research projects are reviewed on an annual basis. The approval period may be shorter for studies that may pose a greater risk or where critical information relevant to risk and benefit may be available on a periodic basis. As the PI for your study, you are responsible for submitting a CGIRB Continuing Review Status Report at the appropriate intervals.

CGIRB support staff will notify you in writing approximately 2 months in advance of the deadline for submission of the continuing review documentation. You may delegate the task of making submissions to CGIRB to a qualified individual; however, as the PI, it is your responsibility to ensure all reporting requirements are met. An investigator's failure to complete and return the requested continuing review information to CGIRB by the Board meeting review date results in the expiration of CGIRB's approval.

• If subjects are enrolled at the site and CGIRB approval expires, the investigator is required to submit a transition plan for all active subjects to CGIRB in writing within 5 business days.

Failure to submit complete continuing review information by the study expiration date does not qualify for an appeal. Investigators who do not receive CGIRB re-approval because of failure to submit the requested information are considered to be noncompliant with CGIRB reporting requirements and must submit a new investigator application for CGIRB approval in order to continue in the study.

FINAL STUDY CLOSEOUT

When a study is closed or canceled, the investigator must submit a Invesigator Site Closure Request and Final Study Status Report to CGIRB. CGIRB considers the study closed at your site when the final study monitoring visit occurs, or in the absence of monitoring, when the study summary is provided to the sponsor. The report must be submitted to CGIRB within 90 days of study closure. In turn, CGIRB will send a letter of acknowledgement regarding the closeout notification.