Start Up
Who is responsible for requesting a coverage analysis if needed?
The Pre-Award Specialist is responsible for requesting a coverage analysis directly with Ankura or another acceptable vendor.
Which positions are responsible for executing and reviewing invoices, and what are their respective OurDay access roles?
How soon must the Post Award Manager change the status within the closeout form after receiving the email notification?
The Post Award Manager must change the status within 4 days of receiving the email notification.
What is our regulatory CTSU QA process?
1. Reg specialist reviews weekly
2. QA specialist reviews weekly
3. QAE manager reviews weekly.
4. Unit Manager reviews monthly.
Who is responsible for the studies in under consideration?
TTA Manager
What regulatory tasks should be done in IAP2?
PRC submission, IRB application, reg documents completed and sent to sponsor, and the SIV.
What is the OnCore task list naming convention?
AME_CTO#_Description of amendment
Should regulatory close out a study if there are pending invoices? Why or why not?
No, if we close out a study with the IRB prior to all invoices being paid, the sponsor can ghost us on payment and we will lose money.
What is the purpose of the Partial Quality Assurance Request?
Its purpose is to ensure that there is no mention of variable billing within the draft budget and contract before finalization.
How long should Ankura take to complete the coverage analysis, and what happens if there are delays?
Ankura should complete the coverage analysis within 14 business days. Delinquencies beyond 18 days must be escalated to the financial manager, who will then escalate the concern to the Ankura manager and PI.
What is the purpose of the Resource Allocation Feasibility Team (RAFT) in the activation process?
To provide multidisciplinary consultation for trials needing input from non-CTO ancillary service providers.
When creating a patient travel invoice in OnCore, what must be entered in the Invoice Number field?
The Invoice Number should include the GR#, followed by an “A”, and today’s date (e.g., GR082940071723A).
What should a QA specialist do when they receive a close out visit request in redcap?
They should go to the close out visit SP form and ask finance if there are any pending invoices.
How soon must the Pre-Award Manager review the draft budget after receiving the email notification?
The Pre-Award Manager must review the draft budget within 3–4 business days of receipt.
What should the Pre-Award Manager verify regarding milestones in the draft budget?
They should confirm that milestones not part of the per-patient amount are correctly identified and that the sum formula is updated in the totals column.
What documents must be attached when sending the coverage analysis request email to Ankura?
The email must include:
IB, IND letter, or any manuals if available
What are the steps to an amendment?
1. Receive amendment
2. Submit amendment in SP Form
3. Create amendment task list
4. Submit ame to IRB
5. Implement amendment
What tasks should be completed for regulatory to close with the IRB?
The only items pending after close out should be final DOA log and termination letter from IRB.
What items are QAed within the regulatory unit?
ICFs, IRB applications, amendment approvals, DTLs/DOAs
What is a new item that was added to our IRB applications this year?
What must you do once you hit a roadblock in study start up?
When creating an invoice in OnCore, what report does the Research Finance Post Award Coordinator use, and what information must be entered to generate the Excel sheet?
The Research Finance Post Award Coordinator uses the Invoiceable Items Report in OnCore. To generate the Excel sheet, they must enter a date range and the Management Group (HCC CTO).
What status should the post award team select if the cash balance is negative and invoices have not been paid?
The status should be Terminate Not Ready.
What is the purpose of the eIRB HCC CTO PRA Departmental Approval?
The purpose is to ensure that the accurate cost language is provided within the IRB application
What needs to be done after receiving the activation letter from regulatory to ensure the calendar is available in Epic?
Once the activation letter is received, the SPARC calendar must be pushed into Epic. If the calendar includes hospital services, submit the request through all steps (1–5) and confirm it appears in the Epic Queue. If it does not include hospital services, add CPT code 992117, then submit the request so the study appears in the Epic Queue.