UMB Coeus Users Group

1. UMB Coeus Users Group October 17, 2007

2. Today’s Agenda • Business Processes using Coeus • New form for participating department sign-off • Proposals being submitted to Grants.gov • Proposals that include clinical research • Industry-funded • Other sponsors • Other Coeus updates

3. UMB Coeus Users Group • Voluntary • Any Coeus User may attend • Forum for information and input about Coeus business process changes, tips, tools and problem resolution • Expectation that members of the Users Group will be (or become) expert resources for other Users in their unit • Expectation that members of the Users Group will disseminate Coeus information from this forum to other Users in their unit

4. Coeus Routing vs Hard Copy • Coeus to replace hard copy by October 1, 2008 • Coeus Proposal Development captures identical data as currently obtained with current routing form • Change in process for obtaining participating department/school sign-off

5. Coeus Routing • Same data, yes/no questions and other information from hard-copy routing form is collected in Coeus • Coeus facilitates a work flow of electronic approvals • Sign-offs external to the standard “routing map” (PI - Chief/Director - Chair - Dean - ORD) are still required when applicable and are included as Narrative Attachments in Coeus

6. Coeus Routing...Sign-offs from Participating Departments • Proposed Solution: New form developed by School and ORD representatives • New form (see handout) will collect • Department sign-offs • DRIF credit • Cost sharing approval • Over-salary-cap will still be handled with a yes-no question • Completed/signed form will be uploaded as a Narrative Attachment in Coeus

8. Business processes • How to create an electronic routing document in Coeus • Grants.gov proposals • Proposals that include clinical research

9. Grants.gov proposals • First, identify funding opportunity via NIH Guide or Grants.gov • Create proposal and link to Grants.gov • Create a detailed budget or a modular budget • Detailed budget may include subaward budget, which must be completed in PureEdge, then uploaded to the proposal

10. Grants.gov proposals • Upload Narratives - follow agency instructions • Complete preparation to “Submit for Approval” (= “routing”) • Answer yes-no questions • Include relevant Grants.gov forms (similar to selecting correct “Optional Forms” in PureEdge) • ASK ORD TO PRE-REVIEW • PI certifies in Coeus and Submits for Approval

11. ORD Pre-review - Why? • In Coeus, once you “Submit for Approval”, data and budget cannot be modified; new narratives cannot be added; biosketches cannot be corrected • If the proposal is rejected at any routing stop because changes/corrections are needed, the routing starts over with the PI • Coeus sends emails to every Approver and Alternate Approver at each routing stop -  rejections and re-submissions =  emails! • Email notifications can be turned off, but then Approvers must go into Coeus to review their “in-box” • This parallels the current “best practice” for PureEdge files

12. Grants.gov proposals • Department advises ORD when all Narrative Attachments are final • ORD submits proposal to Grants.gov (via Coeus) • Proposal status is available in Coeus, then via NIH Commons (or other agency systems)

13. Grants.gov Proposals • Validation Errors have been reduced using Coeus • If there is an Error or if for any other reason a changed/corrected application must be submitted, the department duplicates the original proposal and (after ORD pre-review) Submits for Approval • Unless changes are substantive, ORD “bypasses” the various approval stops and resubmits to Grants.gov

14. Grants.gov Proposal Resources • Be sure to use the checklist and process information available on the Coeus website under Proposal Toolkit • Also on this page is the PureEdge Subaward Budget file that is required for Coeus (do NOT use one from the funding announcement) • http://www.umaryland.edu/coeus/tools.html

15. Clinical costs included in proposal budgets • Hot audit issue: inappropriately billing Medicare for items or services in a clinical trial that are ineligible or covered by a grant/contract • Rush University - settlement of $1 Million as a result of improper Medicare/Medicaid billing for cancer treatments for patients enrolled in a clinical trial

16. New processes for clinical research budget reviews • Affects ALL clinical research regardless of sponsor • Clinical research subject to billing review: • Will require a human subject informed consent • Will involve the provision of clinical care services at UMMC and/or one or more UPI professional faculty practice plans

17. New processes 2 • Center for Clinical Trials (CCT) reviews study budgets/payment schedules and sets up a “billing plan” • Already in place for industry-funded studies • Identifies costs that may be charged to Medicare or third-party insurers versus costs that are to be paid by the study (i.e., by the company or other funder)

18. Proposed clinical billing review (as of 10/9/07) • Industry-funded studies • Undergo a full billing review before budget is finalized with Sponsor • Billing review is done in parallel with agreement negotiation and IRB submission/review • Other sponsors (NIH, Army, Foundations, etc) • CCT will consult on proposal budget and provide current costs for UMMS procedures • Full billing review will be done “just-in-time” - budget should be submitted to CCT at the time the IRB protocol is submitted for review • CCT will only review costs of clinical procedures - not the entire proposal budget • CCT is expected to issue instructions soon and to have forms (on website) for each study category

19. Coeus Business Processes: Industry-funded clinical studies • Submit Clinical Research Request Form (found on CCT’s website http://medschool.umaryland.edu/cct/ ) • Submit information to CCT for billing review in parallel with IRB protocol submission • Check CCT’s instructions - retrospective clinical data review and some other clinical studies MAY be exempt from billing review • Based on the information provided in the Clinical Research Request Form, CCT will advise PI/Department whether CCT or ORD will review and negotiate the agreement • Any agreement information received from the company should be provided to CCT or ORD (whichever is assigned to negotiate) • At this point, the processes differ slightly...

20. Industry-funded clinical studies - CCT negotiating • If CCT is negotiating the agreement (company-initiated protocol, drug or device is being tested) • CCT will notify PI/Department when Agreement negotiations are completed and will request routing • Create proposal in Coeus • 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. • Attach an electronic copy of the clinical study agreement to Narrative Type “Narrative”.

21. Industry-funded clinical studies - CCT negotiating • Answer the yes-no questions and have the PI certify and Submit for Approval • ORD reviews and approves in Coeus • ORD notifies CCT that routing is complete. • CCT forwards executed clinical trial agreement to ORD for award processing.

22. Industry-funded clinical studies - ORD negotiating • If ORD is negotiating the agreement (investigator-initiated clinical research, observational/data collection, retrospective data review, and similar) • Begin routing approval process when CCT billing review (when required) is completed and budget has been finalized • Create proposal in Coeus • 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. • Attach the project Scope of Work or the Protocol to Narrative Type “Narrative”.

23. Industry-funded clinical studies - ORD negotiating • Answer the yes-no questions and have the PI certify and Submit for Approval • ORD reviews, verifies that the budget and scope of work/protocol are the final versions, and approves in Coeus • When the agreement has been signed by both parties, ORD processes award for chartstring set-up by Restricted Funds

24. “Non-industry” sponsored clinical research (Federal, Foundations, etc) • Before preparing budget, obtain current UMMS costs/fees from CCT • For some studies it may be helpful to consult with CCT on what the proposal should include as it relates to the Federal Centers for Medicare and Medicaid Services Clinical Research Policy

25. “Non-industry” sponsored clinical research (Federal, Foundations, etc) • Prepare proposal according to sponsor instructions and Coeus processes http://www.umaryland.edu/coeus/tools.html • If funding is likely, submit the IRB protocol for approval, and submit clinical budget information to CCT for review along with protocol information, according to CCT instructions • In other words, the billing review will be done on a “just-in-time” basis along with the IRB approval process • During award review (before chartstring set-up), ORD will look for the clinical billing review or a document exempting the project from the review process

26. UMB Coeus User GroupUpcoming meeting dates • Mark your calendar! • November 14 - 1:00 PM • December 11 - 1:00 PM • At HSF II Auditorium