6. To access the online IRB protocol module, click the "My IRB Protocol" link found in the top navigation of any CoeusLite screen

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1 IPFW CoeusLite Online IRB Process CoeusLite IRB Login 1. Open a web browser page and go to: 2. Enter your Career Account User Name in the USERNAME field 3. Enter your Purdue Career Account Password in the PASSWORD field 4. Click Enter or the Login button 5. Application should open to the CoeusLite homepage 6. To access the online IRB protocol module, click the "My IRB Protocol" link found in the top navigation of any CoeusLite screen Create New Protocol 1. Open the IRB Home screen 2. In the Create New section at bottom of page, click Create New Protocol 3. New IRB protocol record should open 1 P age

2 1: Protocol Details General Info 1. In section 1: Protocol Details, click General Info 2. Type: enter either Request for Non Exempt Approval or Request for Exemption 3. Title: enter the protocol title Investigators/Study Personnel Add Investigators/Study Personnel 1. Click Investigators/Study Personnel in left navigation 2. Click Add Investigators/Study Personnel Details at top of page 3. Click Search/Add Person and complete standard Coeus search NOTE: If the person to add cannot be found, they will need to be added by Purdue era as a new Person/User. Complete the online new user request at: or coeushelp@purdue.edu. 4. Select person to add from search results 2 P age

3 5. Protocol Role: select appropriate value (Principal Investigator, Co Investigator, Study Personnel) 6. Person Role: for Study Personnel ONLY, manually enter role on protocol 7. Affiliation: select appropriate value from dropdown list 8. Click Save 9. Repeat all steps for each person to add Remove Investigators/Study Personnel 1. To remove a listed Investigator/Study Personnel, click the Remove link next to the person to be deleted. 2. Click OK in the confirmation popup Correspondents DO NOT USE Funding Source In section 1: Protocol Details, click Funding Source Sponsor External Funding 1. Type: select Sponsor External Funding from dropdown 2. Number/Code: click Search, complete standard Coeus Sponsor search, and select appropriate Sponsor from list 3 P age

4 Departmental Funding 1. Type: select Departmental Funding from dropdown 2. Number/Code: click Search, complete standard Coeus Unit search, and select appropriate department from list Other Self Funding 1. Type: select Other Self Funded from dropdown 2. Number/Code: manually enter description of the funding source (NOTE: only value that makes Number/Code free text, all others are searches) Proposal Development Record Funding 1. Type: select Development Proposal from dropdown 2. Number/Code: click Search, complete standard search of Coeus Proposal Development records, and select appropriate department from list Institute Proposal Record Funding 1. Type: select Institute Proposal from dropdown 2. Number/Code: click Search, complete standard search of Coeus Institute Proposal records, and select appropriate department from list Notes DO NOT USE 3: Attachment Uploads Add New Attachment 1. In section 3: Attachment Uploads, click Attachments 4 P age

5 2. Click Add New Document 3. Document Type: select appropriate value from dropdown list NOTE: For the crosswalk of when to use each available Document Type, see: 4. Description: manually enter unique identifier for the uploaded document 5. Upload File: complete standard Browse/Upload to attach file 6. Click Save 7. Repeat all steps for each additional attachment Modify Existing Attachment 1. Click Modify next to the attachment to revise 2. Document Type: Document Type cannot be revised 3. Description: revise as desired 4. Upload File: complete standard Browse/Upload to overwrite existing attachment with revised version 5. Click Save Delete Attachment 1. Next to the attachment to delete, click the Remove link 2. Click OK in the confirmation popup 5 P age

6 4: Submit 1. In section 4: Submit, click Submit to IRB 2. In Protocol Actions screen, click Submit For Review 3. Validation Checks will run, click OK to continue 4. Click OK in confirmation popup 5. Type: select Initial Protocol Application from dropdown 6. Review Type: select Pending IRB Determination from dropdown 7. Type Qualifier: select New Submission to IRB for the first submission or Revisions Requested by IRB for any submission of revisions 8. Click Submit 9. Click OK in confirmation popup NOTE: Coeus will automatically send a system generated notification to IRB Administration that informs them of the submission. Not external to IRB Admin is necessary. 10. The Successfully Submitted screen should display stating the application is now electronically submitted to IRB for intake and review. Click Return to Protocol to review or exit Create New Amendment 1. Open the IRB Home screen 2. In the Create New section at bottom of page, click Create New Amendment 3. Select Active protocol to amend from popup list 6 P age

7 4. New Amendment should open to Amendment Summary screen OR 5. Click the Protocol Search link in the top navigation bar 6. Complete standard Coeus search and select protocol to amend from results list NOTE: It is recommended that the protocol number is used for search criteria and the asterisks (*) is always applied as a wildcard on either side of entered search criteria. 7. In Create Submission section, click New Amendment 8. New Amendment should open to Amendment Summary screen Amendment Summary 1. Main Text Box: enter brief description of what is being revised 2. Check the Add/Modify Attachments checkbox Upload New Amendment Attachment 7 P age

8 1. In section 3: Attachment Uploads, click Attachments 2. Click Add New Document 3. Document Type: select Other Attachments from dropdown list 4. Description: manually enter unique identifier for the uploaded Amendment document 5. Upload File: complete standard Browse/Upload to attach file 6. Click Save 7. Repeat all steps for each additional Amended attachment Amend Approved Attachments 1. Click Amend next to the attachment to revise 2. Document Type: Document Type cannot be revised 3. Description: revise as desired 8 P age

9 4. Upload File: complete standard Browse/Upload to overwrite existing attachment with revised version 5. Click Save Submit 1. In section 4: Submit, click Submit to IRB 2. In Protocol Actions screen, click Submit For Review 3. Validation Checks will run, click OK to continue 4. Click OK in confirmation popup 5. Type: select Amendment from dropdown 6. Review Type: select Pending IRB Determination from dropdown 7. Type Qualifier: select New Submission to IRB for the first submission or Revisions Requested by IRB for any submission of revisions 8. Click Submit 9. Click OK in confirmation popup NOTE: Coeus will automatically send a system generated notification to IRB Administration that informs them of the submission. Not external to IRB Admin is necessary. 10. The Successfully Submitted screen should display stating the application is now electronically submitted to IRB for intake and review. Click Return to Protocol to review or exit Create New Renewal (Continuing Review) 1. Open the IRB Home screen 2. In the Create New section at bottom of page, click Create New Renewal w/ Amendment 3. Select Active protocol to Renew from popup list 4. New Amendment should open to Amendment Summary screen OR 5. Click the Protocol Search link in the top navigation bar 6. Complete standard Coeus search and select protocol to amend from results list NOTE: It is recommended that the protocol number is used for search criteria and the asterisks (*) is always applied as a wildcard on either side of entered search criteria. 7. In Create Submission section, click New Renewal 9 P age

10 8. New Amendment should open to Amendment Summary screen Renewal Summary 1. Main Text Box: enter brief description of anything being revised 2. Check the Add/Modify Attachments checkbox Upload New Continuing Review Attachment 8. In section 3: Attachment Uploads, click Attachments 9. Click Add New Document 10 P age

11 10. Document Type: select Continuing Review Application from dropdown list 11. Description: manually enter unique identifier for the uploaded Continuing Review document 12. Upload File: complete standard Browse/Upload to attach file Repeat all steps for each additional Amended attachment Update Approved Attachments 6. Click Amend next to the attachment to revise 7. Document Type: Document Type cannot be revised 8. Description: revise as desired 9. Upload File: complete standard Browse/Upload to overwrite existing attachment with revised version 10. Click Save Submit 1. In section 4: Submit, click Submit to IRB 2. In Protocol Actions screen, click Submit For Review 3. Validation Checks will run, click OK to continue 4. Click OK in confirmation popup 5. Type: select Continuing Review/continuation and Amendment from dropdown 6. Review Type: select Pending IRB Determination from dropdown 7. Type Qualifier: select New Submission to IRB for the first submission or Revisions Requested by IRB for any submission of revisions 8. Click Submit 9. Click OK in confirmation popup 11 P age

12 NOTE: Coeus will automatically send a system generated notification to IRB Administration that informs them of the submission. Not external to IRB Admin is necessary. 10. The Successfully Submitted screen should display stating the application is now electronically submitted to IRB for intake and review. Click Return to Protocol to review or exit Complete IRB Requested Revisions IRB Requested Revisions to protocol submissions will be handled directly with the PI outside of Coeus. If an Investigator provides Requested Revisions to IPFW Admin staff, please forward to IRB Admin by with the corresponding Coeus IRB Protocol number. Miscelleanous Maintain Protocol Specific Accesses Every Coeus IRB Protocol record has its own permissions list that can be modified. IRB Protocol information is restricted at Purdue, therefore, initially only the person who created the record will be able to edit it. In addition to the creator, only the Principal Investigator will have the ability to view the record. Protocol access may be manually given to additional people on a record specific basis however. o Protocol Aggregator Users with this role can view, edit, and create additional submissions. They can also Submit to IRB and utilize the IRB Home Create New buttons. o Protocol Approver DO NOT USE o Protocol Viewer Users with this role can only view the protocol 1. Open the specified protocol record 2. Go to the Record Tools section located in the bottom of the Left Navigation 3. Click the Access Permissions link 4. Click Add User in the appropriate role section 5. Complete the standard search box to locate the User you wish to add 6. Enter the name of the person to add using standard Coeus search criteria and click Search NOTE: Best practice for searching by name is to enter the persons LAST NAME with an asterisks (*) before AND after. 7. Click on the appropriate person from the Search Results NOTE: Only people who have an established User Account may be added to specific IACUC protocol records. If the person you are looking for does not appear in Search Results, please contact coeushelp@purdue.edu for assistance. 8. User now has the accesses that were assigned Change Protocol Principal Investigator 1. The Investigator/Study Personnel screen must be open. 12 P age

13 2. Click on the name of the currently listed PI if listed person will remain on protocol with a different role 3. Change the Protocol Role of the original PI 4. Click "Save" 5. Click on new PI's name or Add Investigator and designate as Principal Investigator 6. Click "Save" Withdraw a Submission Complete a Withdraw action when there is an IRB Protocol submission that has already been received by IRB but needs to be pulled back for revisions. Only protocols with a status of Submitted to IRB may be withdrawn. 1. Click the Protocol Search link in the top navigation bar 2. Complete standard Coeus search and select protocol to withdraw from results list NOTE: It is recommended that the protocol number is used for search criteria and the asterisks (*) is always applied as a wildcard on either side of entered search criteria. 3. In section 4: Submit, click Submit to IRB 4. On the Protocol Actions screen, click Withdraw Submission. Withdraw Submission window should open. 5. Comments: Enter text that explains the purpose of the Withdraw 6. Click Submit Abandon a Submission Complete an Abandon action when there are IRB Requested Revisions pending on a Protocol submission and the PI does not want to continue with the submission. Only protocols with a status of Specific Minor Revisions Required or Substantive Revisions Required may be Abandoned. 1. Click the Protocol Search link in the top navigation bar 2. Complete standard Coeus search and select protocol to Abandon from results list NOTE: It is recommended that the protocol number is used for search criteria and the asterisks (*) is always applied as a wildcard on either side of entered search criteria. 3. In section 4: Submit, click Submit to IRB 4. On the Protocol Actions screen, click Abandon. Abandon window should open. 5. Comments: Enter text that explains the purpose of the submission abandonment 6. Click Submit 13 P age