Coeus Business Process for routing of clinical trial agreements when negotiated by the SOM Center for Clinical Trials

This Business Process describes routing of clinical trial agreements through Coeus when the clinical trial agreement has been negotiated by the School of Medicine Center for Clinical Trials.  
 
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1.   SOM Center for Clinical Trials (CCT) notifies Department that clinical study agreement has been finalized and provides Department with a copy of the agreement for routing
 
2.   Create a new proposal record in the Proposal Development Module in Coeus by entering proposal title, start and end dates of the performance period, proposal type, activity type, and sponsor. (If sponsor does not exist in Coeus, PI/Administrator will need to fill out the “Request New Sponsor” form and submit to ORD via the UMB Coeus Website.  Until notification is received from ORD, leave the sponsor field blank.) Enter the Sponsor on the Proposal Detail tab when available but prior to submission for approval. [NOTE:  At this point and throughout the process, the record may be saved and the proposal continued later.]
 
3.   Complete Proposal Detail, Organization, Investigator, Key Person, and Special Review Tabs
 
4.   In the budget module, ensure that OH Rate Type “TDC” has been selected.  For budget entry, in Period 1, choose cost element “Other Operating Expenses” and enter the anticipated direct cost amount, then calculate and save according to standard procedures.
 
5.   Attach an electronic copy of the clinical study agreement to Narrative Type “Narrative”.
 
6.   If CCT performed a billing/Medicare coverage analysis for this study, scan and attach the Research Compliance Workbook and Study Budget to Narrative Type “Other”.
 
7.   If all research study costs will NOT be covered by sponsor payments, complete and attach a Cost Sharing Approval Form to Narrative Type “Cost Share Form”.

8.   Answer Yes-No Questions
 
9.   Certify the PI; print, scan and upload the signed/dated certification to Narrative Type “Signed Certification”
 
10.      Principal Investigator submits for approval through the routing process in Coeus
 
11.      ORD reviews and approves in Coeus
 
12.      ORD notifies CCT that routing is complete. 
 
13.      CCT forwards executed clinical trial agreement to ORD for award processing.