The IRB requires an amendment to note any changes related to an approved study. The Amendment application must describe the modification(s) requested including reasons for the change, whether the modification will increase or decrease the risk of harm to the subject, and whether the consent form requires modification.
Please Note: For-profit and/or industry sponsored studies must pay IRB fees before the review process begins.
Amendment Application Submission Requirements
Investigators requesting changes, modifications, and addenda to a currently approved research protocol must submit a completed ERICA amendment application. Changes should be submitted no later than 30 days after receipt from study sponsors, collaborators, etc.
Changes must be made to all documents or forms in ERICA that relate to the specific change(s) requested. Documents should be attached to the Documents and Attachments page of the update study portion of the application or revised in the update study portion of the application.
Submitting an Amendment in ERICA
- Open the study.
- Click on the Amendments tab.
- Click the Create button.
- Complete the amendment application entirely.
- Attach any updated/revised documents to the Update Study application.
- Submit the amendment to the IRB for review.
Note: It is the PI's responsibility to handle the submission of information. This includes the submission of all applications pertaining to the study, as well as revisions requested during the IRB review of an application.