Post-Approval Management | IRB
The information on this page pertains to studies that have already been approved or registered by the IRB. If you are preparing a new submission, please refer to the Forms for Initial Submission.
Types of Post-Approval Requests
Post-approval requests include required annual continuing reviews, modifications to approved proposals, adverse event reporting, and project closures.
Step 1: Prepare your documentation. As you prepare your documentation, ensure that you provide a complete request. The IRB will not process your request until it meets submission standards.
- Post-Approval Request Form: Downloadable in IRBNet. Complete according to your request.
Updated proposal materials: Update proposal materials to reflect and modifications for which you seek approval. Even if you are not requesting any changes, please upload the most recent stamped version of your proposal materials for the ease of the IRB review process (stamped materials are available by clicking on the Reviews tab of your study in IRBNet). This will allow the IRB to update the stamped documents without delay.
- If, per your proposed modifications, additional supplementary forms are necessary, please view the Forms for Initial Submission and complete the necessary documentation.
Be sure to submit (and, as necessary, make modifications to) the final, approved version of the study documentation that was part of your initial submission.
For continuing review and modification requests, any proposed changes to your study must be noted in your Post-Approval Requests form [quote the modified language] and modified in your study documentation. This includes the addition and/or removal of study personnel, changes made to study dates and/or timelines, and all changes made to the study protocol and participant documents.
- Signatures: Be sure to share the study with and obtain signatures from any new personnel you are adding to the study. Refer to the instructions on the Submission Guidelines page for sharing with researchers and gaining their signatures. The Faculty PI and any new research team members are required to sign post-approval request packages in IRBNet.
Step 2: Submit via IRBNet.
Follow the step-by-step guidance on Submission Guidelines under the section "Preparing an Additional Package for a Previously-Submitted Project in IRBNet."
Step 3: Check in.
You will be notified when your submission has been processed by the IRB (Acknowledged) and when it is approved just like with your initial submission. Feel free to reach out to your IRB representative with questions or use IRBNet Messaging to send the IRB a message.