Amendment (Change) Request for a Currently-Approved Study

 

1. Create new study documents and/or revise existing study documents

Your amendment may involve adding new documents, like a new advertisement or survey.  Your amendment may involve revising existing study documents to reflect the change you are making. Keep in mind that information relevant to your change may affect multiple documents. For instance, adding a new survey to your study will likely require revisions to your protocol and perhaps your application form and consent form.

If you are making changes to documents that were previously submitted to and approved by COMIRB, it is necessary to upload 2 copies of the revised version of each document you are amending. One copy of the revised document should be a marked-up version using Microsoft Office’s “track-changes” feature to show changes made, and the second document should be the clean (no markup) version for stamping. If the “track-changes” feature is not available, please submit a highlighted (in yellow or green) version, or provide a detailed list of changes. Important note: it is not possible to track changes or highlight the smart PDF version of the Application for Protocol Review Form.‚Äč

2. Include necessary information

Include a cover letter that tells us about your amendment.  What is the purpose of the amendment?  What is the rationale for the amendment?

3. Complete the Change Form

Please be detailed about the study changes (including personnel changes).

4. Submit the materials to COMIRB via the InfoEd eRA website