<p> Indiana University Health Bloomington Institutional Review Board (IRB) Request to Re-Open a Closed Study</p><p>Study Title: IRB#: </p><p>Principal Investigator: Email: Phone: Fax: </p><p>Study Coordinator: E-mail: Phone: Fax:</p><p>1. Reason for re-opening the study at this time: Re-open for Enrollment Study was closed less than 6 months ago. Date of IRB closure. // Study was closed more than 6 months ago. A new application must be submitted to the IRB. Date of IRB closure. // Audit Site Visit Date of audit // Query for data clarification/data existing at the time of study closure Query for new data related to events occurring since study closure To Notify Subjects of their Randomization and the Study Results Other: </p><p>2. Have there been any study-related unanticipated problems or serious adverse events since the study closed? No Yes, If yes, include copies of the event(s) with this submission. </p><p>3. If requesting to re-open to enrollment, have there been any amendments, changes in investigators or study team, updated Investigator’s Brochure, etc. No Yes, If yes, please include the information with this submission.</p><p>4. For notifying subjects of their randomization and study results how will study subjects be notified, e.g. letter, CD, video, newsletter? </p><p>5. If PI has left this area, who will be: a. Coordinating notification process? Name: E-mail: Phone/Fax:</p><p> b. Signing letter to subjects? Name: E-mail:Phone/Fax:</p><p>06/24/2014 RR 404-A 1 This form must be electronically signed by the Principal Investigator or designee. The electronic signature certifies that the information provided above is accurate, current and complete.</p><p>06/24/2014 RR 404-A 2</p>