NOTE: These instructions are specific to site Amendments for single IRB (SIRB) studies using the ERICA "Site-Control Model". Instructions for all other types of Amendments can be found on our Amendments page. For all revisions to approved documents, remember to attach a tracked and clean version of your documents with the Amendment.
During the course of a study, updates and changes may need to be made and documented. Any changes to an approved IRB study require an Amendment to be submitted and approved prior to the implementation of the changes. Amendments can be created by Site PIs and Site Contact Persons, but only the Responsible PI and Site PIs can submit an application.
STEP 1: Create the pSite Amendment.
An Amendment can be submitted from the Participating Site (pSite) workspace by clicking on “Create Amendment” under the Activities menu:
A pop-window will appear where comments can be added and any supporting documents can be attached. These comments will not be part of the amendment application, but will be visible to the IRB staff and IRB members. Click “OK” to create the Amendment. The site workspace will be updated to show the amendment’s creation along with the name of the amendment.
Clicking on the name of the amendment will redirect you to the pSite Amendment workspace.
The pSite Amendment workspace looks similar to the workspace for the pSite's main workspace, except the name of the page will show the Amendment’s information along with the workflow states of the amendment leading up to its approval.
STEP 2: Navigate to the Amendment application.
Click the “Edit Amendment” button to begin filling out the Amendment application:
STEP 3: Fill out the pSite Amendment application.
The editable pages of the Amendment look similar to the initial application edit page, with details from the original pSite application auto-populated into the fields of the “Site Information” page.
Click "Continue" though the application and complete each section according to the instructions on the page. The next two pages are where the details and information for the Amendment will be provided.
STEP 4: Attach your Tracked and Clean Documents.
On the Documents page of the Amendment application, you can attach documents for IRB review. If the pSite Amendment includes any changes to previously approved, site-specific documents, attach tracked and clean copies of your documents in the appropriate section of the Documents page.
- Changes to study wide documents/templates should be made via a study wide Amendment, not a pSite Amendment.
- Documents on pSite applications should be site-specific versions of the documents approved on the main (study wide) application.
- Documents that must include the IRB approval stamp (i.e. consent forms) must be formatted properly for ERICA before attaching. Please review our guidance on Submitting Documents for IRB Approval for instructions.
STEP 5: Check for Errors.
After completing the Amendment application, it is recommended that you click the “Validate” button in the top left of the page to check for any fields that may have been missed and are required to be filled out before the application can be submitted. Clicking on the blue help text to the right of the warning icon will redirect you to the missing fields in the application.
STEP 6: Submit the Amendment.
Once the details of the amendment have been provided, and there are no validation errors appearing on the edit page, submit the application to the IRB by clicking "Submit" under the Activities menu:
From there, your Amendment will be sent to the IRB's general assignment queue and routed to a reviewer from there. Track the progress of your application by monitoring the state label on the Amendment workspace. Our ERICA Status Key can tell you more about each status label. Estimated review times can be found on our Submissions & Review Schedules page.