Last Modified: 7/13 IPFW CoeusLite Online IRB Process CoeusLite IRB Login 1.
2.
3.
4.
5.
Open a web browser page and go to: https://coeus.itap.purdue.edu/coeus/userAuthAction.do Enter your Career Account User Name in the “USERNAME” field Enter your Purdue Career Account Password in the “PASSWORD” field Click Enter or the “Login” button 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 a g e Last Modified: 7/13 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: https://www.purdue.edu/business/coeus/Requests/access.php or email coeushelp@purdue.edu . 4. Select person to add from search results 2 | P a g e Last Modified: 7/13 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 a g e Last Modified: 7/13 3. Click “Save” 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 3. Click “Save” 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) 3. Click “Save” 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 3. Click “Save” 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 3. Click “Save” 
Notes – DO NOT USE 3: Attachment Uploads Add New Attachment 1. In section 3: Attachment Uploads, click “Attachments” 4 | P a g e Last Modified: 7/13 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: http://www.purdue.edu/business/coeus/IRB_Protocols/Admin_Guide_IRB/document_type_crosswalk.html
4.
5.
6.
7.
Description: manually enter unique identifier for the uploaded document Upload File: complete standard Browse/Upload to attach file Click “Save” Repeat all steps for each additional attachment Modify Existing Attachment 1.
2.
3.
4.
Click “Modify” next to the attachment to revise Document Type: Document Type cannot be revised Description: revise as desired 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 a g e Last Modified: 7/13 4: Submit 1.
2.
3.
4.
In section 4: Submit, click “Submit to IRB” In Protocol Actions screen, click “Submit For Review” Validation Checks will run, click “OK” to continue 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 email notification to IRB Administration that informs them of the submission. Not external email 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 a g e Last Modified: 7/13 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 3. Click “Save” 
Upload New Amendment Attachment 7 | P a g e Last Modified: 7/13 1.
2.
3.
4.
5.
6.
7.
In section 3: Attachment Uploads, click “Attachments” Click “Add New Document” Document Type: select “Other Attachments” from dropdown list Description: manually enter unique identifier for the uploaded Amendment document Upload File: complete standard Browse/Upload to attach file Click “Save” 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 a g e Last Modified: 7/13 4. Upload File: complete standard Browse/Upload to overwrite existing attachment with revised version 5. Click “Save” 
Submit 1.
2.
3.
4.
5.
6.
7.
In section 4: Submit, click “Submit to IRB” In Protocol Actions screen, click “Submit For Review” Validation Checks will run, click “OK” to continue Click “OK” in confirmation popup Type: select “Amendment” from dropdown Review Type: select “Pending IRB Determination” from dropdown 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 email notification to IRB Administration that informs them of the submission. Not external email 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 a g e Last Modified: 7/13 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 3. Click “Save” 
Upload New Continuing Review Attachment 8. In section 3: Attachment Uploads, click “Attachments” 9. Click “Add New Document” 10 | P a g e Last Modified: 7/13 10.
11.
12.
13.
14.
Document Type: select “Continuing Review Application” from dropdown list Description: manually enter unique identifier for the uploaded Continuing Review document Upload File: complete standard Browse/Upload to attach file Click “Save” Repeat all steps for each additional Amended attachment 
Update Approved Attachments 6.
7.
8.
9.
Click “Amend” next to the attachment to revise Document Type: Document Type cannot be revised Description: revise as desired Upload File: complete standard Browse/Upload to overwrite existing attachment with revised version 10. Click “Save” 
Submit 1.
2.
3.
4.
5.
6.
7.
In section 4: Submit, click “Submit to IRB” In Protocol Actions screen, click “Submit For Review” Validation Checks will run, click “OK” to continue Click “OK” in confirmation popup Type: select “Continuing Review/continuation and Amendment” from dropdown Review Type: select “Pending IRB Determination” from dropdown 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 a g e Last Modified: 7/13 NOTE: Coeus will automatically send a system generated email notification to IRB Administration that informs them of the submission. Not external email 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 email 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 a g e Last Modified: 7/13 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 a g e