How Does the PI make Pre Review ICF Changes? 1 You, as PI of a study, have received notification from the IRB that Changes [are] required by IRB Staff. These changes include a request for a revision of the consent document. You should see the following in your Inbox when you logon: You should click on the blue text study name (it is a hyperlink) to open the study workspace:
The following page will open up: Note that there is 1 Reviewer Note logged You may go to the Reviewer Notes tab here (green circle) to read the reviewer Note(s). 2 Note that the study state is Changes Required by IRB Staff
When you click on the Reviewer Notes tab (green circle on the previous page) you will see the following: 3 To open the Consent Form and make any necessary changes, you will have to go into the SmartForm for this study. You should click on the blue text following the Jump To (See above) You will be taken into your SmartForm application for this study to the page where the Reviewer Note was logged. In this case, you will go to the Consent Process page.
Scroll to the bottom of the Consent Process page until you see the area where you uploaded the consent document. Click on the blue text to open the consent document. 4 Note that anything that is uploaded here will have to be a Clean copy, meaning no tracked changes. DO NOT: Check the Checkbox this is used when you use the delete button above the list. Click on the [Edit] hyperlink. This is used to revise the name of the document and upload the revised document later.
After you open the consent, make the necessary changes and save the document on your hard drive. 5
If your IRB requires a document with the changes tracked, you should save a Clean Version and a Tracked Changes version. 6 After you have made the changes and are ready to upload it to eirb, you should go to the appropriate page in the SmartForm (In this case, the Consent Process page). Note again that you can Upload clean copies ONLY
Click on the Edit button 7 The window below will open. You should click on the browse button. When you hit browse you will be directed to a locate the document on your hard drive You should upload the clean document. Select the document that you want to upload and then hit Open. On the next window, hit OK.
Note that the version of the consent form has changed to 0.02. 8 You should now respond to the Reviewers Note Scroll to the top of the Consent Process page. If the arrow beside Reviewer Notes is pointing to the right, click on the arrow to make it down facing and open the Reviewer Notes text area. (See below) Click on the Click here to respond link (blue text) to add your response.
Add any comments to this page and hit OK 9 After you hit OK you should see the following: Once you finish, you should Save and then Exit. You then are taken to the Study Workspace.
Click Submit Changes 10
The next window will allow you to make final comments and upload any additional documents.. 11 When you click Add you will be taken to the upload window. Upload as instructed previously in this document.
Note that the tracked changes document shows on this window now. Click OK to submit. 12 You are then returned to the Study workspace.
Note that the study state has changed to IRB Staff Review. 13 You have completed the submission. Note: if you click on the Attachments tab (green circle), you will be directed to a page that contains all of the documents that have been uploaded to the study.
When you scroll down the page you will find the consent document. Note the small icon beside the document link. If you click on this icon, you will be able to see all of the versions of this document. 14 See below for the document versioning: If you click on version 0.01, you will see the original document; if you click on version 0.02, you will be able to see the revised document