Request to Re-Open a Closed Study

Indiana University Health Bloomington Institutional Review Board (IRB) Request to Re-Open a Closed Study

Study Title: IRB#:

Principal Investigator: Email: Phone: Fax:

Study Coordinator: E-mail: Phone: Fax:

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:

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.

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.

4. For notifying subjects of their randomization and study results how will study subjects be notified, e.g. letter, CD, video, newsletter?

5. If PI has left this area, who will be: a. Coordinating notification process? Name: E-mail: Phone/Fax:

b. Signing letter to subjects? Name: E-mail:Phone/Fax:

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.

06/24/2014 RR 404-A 2