How to Submit a Modification Application to the IRB
All changes to your study, even minor ones, must receive IRB approval before you implement them. To submit a request for modification, follow the instructions below:
- Log into the AxiomMentor site and click on My Applications
- Click on the Title of the protocol that you will be requesting a modification on
- Scroll down to the bottom of the page to locate the Modifications tab and click on the tab, then click on Create New Modification
- Select the areas of your application you wish to modify/revise then click on Create Modification.
- Click on Edit Application Forms to make revisions and changes directly to your existing application. Revisions will automatically be tracked and you may also upload any revised informed consent documents or protocol instruments for the Application Forms you selected.
- Once you have revised your application, click on View Application Page to go back to your application page, then scroll down to the bottom to locate the Modifications tab.
- In the Modifications tab, click on Questionnaire and complete the Modification Form by answering the questions. To add your answers, click on Add/Edit Answers. When complete, click on Save Answers & Close.
- Go back to your Application Page by clicking Back in the upper right hand corner. In the Modifications tab, click on Submit to submit your modification request to the IRB for review.
- If you wish to upload additional supporting documents to your modification, you may do so by clicking on the red paper icon next to the application status and select Upload Docs from the drop down menu.
An email will automatically be sent to the IRB informing them of your modification submission. IRB staff will review your application within 2 to 3 weeks. Approval notification will be sent by email.