Continuing Review Form

Notes: If there are any documents that need to be revised or if you have stamped documents that need the old stamp removed and/or need to be re-stamped, submit a Mod-CR and mark “Other parts of the study” as part of the modification scope. Revised documents need to be uploaded on the appropriate study page(s) within the Mod-CR.

If your study is no longer enrolling subjects and/or there are study documents (consent forms, recruitment materials, etc.) that will no longer be used (archived), please submit the continuing review via a Mod-CR and mark “Other parts of the study” as part of the modification scope. Be sure to delete the documents you will no longer be using in eIRB before submitting the Mod-CR. In Section 6 below, list the documents that will be archived at this review.

1. Subject complaints/withdrawals: Describe any subject complaints or reasons for withdrawal during the last study approval period.

2. Review of unreportable events (that were not required to be promptly reported via Reportable New Information (RNI)): Have the PI (or responsible designated party) review all the unreportable events (AEs that are not considered UPs, protocol deviations that did not meet criteria for an RNI report) since the last Continuing Review. Briefly summarize those events here and upload a detailed list. You may need to get this information from the sponsor.

3. Reportable events: If any RNI reports have not been submitted per policy (UPs, protocol deviations, significant or unresolved subject complaints), submit them in eIRB via RNI and briefly summarize here:

4. New Information: Please describe any new information relevant to the study. Examples:  Change in funding  Publications or scientific findings relevant to the risks and benefits to subjects  Independent Monitor/DSMB/DSMC findings

1  Interim analysis

5. Subject Status: Briefly describe the current status of study subjects. For example, if this is a drug study, how many subjects are currently receiving the study drug?

6. Archiving Documents: (If study is closing/closed to enrollment and a Mod-CR is being submitted. See notes at top of page for more info.) Please list all study documents you are archiving at this review. Be sure to delete these documents as you progress through the questionnaire.

Examples:  Consent form(s) and recruitment materials, when enrollment is complete  Memos that have already been reviewed by the IRB  DSMB/DSMC reports that have already been reviewed by the IRB  Any document no longer needed for the further conduct of the study

If IRB approval for this study has lapsed, no new subjects may be enrolled and no data may be collected for research purposes until continuing approval is obtained. If study approval has lapsed, please answer the following:

7. Request for study activities: If it is important for subject safety to continue with any study procedures or treatment during the lapsed period, describe the proposed activities and safety rationale. Note: these activities cannot be represented as having ‘IRB Approval’.

8. If the lapse was due to study team (e.g., delay in submission of CR, conflict of interest, etc.) describe why this occurred and your plan to prevent the study from lapsing in the future.