Coeus Lite - IRB Protocol
The Principal Investigator may always elect to complete a new Exemption request from scratch without copying the previously approved Exemption. If this is chosen, disregard the below information and proceed with completion of the new Exemption Request. Below instructions are for revising a previously granted Exemption that has been copied for Investigator initiated revisions.
 NOTE: All revisions to the previously approved exemption must be completed in the appropriate section of the Protocol record to ensure a complete and final protocol exemption is approved. Only those sections with updated information must be revised for submission of the new Exemption. |
Revisions to Exemption section 1: Protocol Details
| NOTE: To revise the listed Investigators/Study Personnel as requested, either add or remove named individuals just as you would when initially creating the submission. |
1. Click on the appropriate screen link in the Left Navigation as directed by Requested Revisions
2. Make all appropriate changes to the identified data fields as requested
3. Click “Save” at the bottom of each screen you have revised
Revisions to Exemption section 2: Questionnaires
1. Go to section 2: Questionnaires and click the first identified Questionnaire to revise
2. Click “Modify” at top of completed Questionnaire
3. Click “Save & Proceed” until you get to first question needing revisions
4. Make all appropriate changes as requested
5. Repeat steps 3 & 4 for all questions requiring revisions
6. When all Questionnaire revisions are complete, click the “Save & Complete” button to finish edits
7. Questionnaire Completion message will display and click “Ok” to navigate to and complete the next applicable Questionnaire that needs revisions
Revisions to Exemption section 3: Attachments
| IMPORTANT: Attachments uploaded into CoeusLite records CANNOT be modified within the system. Attachments must be kept outside of Coeus or downloaded to desktop for editing and then re-uploaded. |
1. Go to section 3: Attachments, click the “Attachments” link
2. Locate appropriate Attachment that needs revisions from the New/Changed Attachments list
3. Click the “View” button next to the Attachment
4. Save the previously submitted document to your desktop if it is not already saved
5. Open the document from desktop and make all appropriate changes as requested. Be sure to HIGHLIGHT changed information
6. When revisions are complete, go back to the Attachments screen in CoeusLite. Click the “Modify” link next to the Attachment to revise
7. Complete the standard Browse/Upload to attach the revised document file and click “Save”
8. Add New Document: Click the Add New Document link and complete standard steps to add a new attachment
9. Remove Document: Click the “Remove” link next to the attachment to delete. Click OK to confirm removal of attachment
| IMPORTANT: Once an attachment has been “Removed”, it is permanently deleted and cannot be restored from the system. If saved to desktop, the attachment may be re-uploaded as a New. |