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 Hay Hill
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 Hay Hill take to complete the coverage analysis, and what happens if there are delays?
Hay Hill 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 Hay Hill 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 an invoice in OnCore, what must be entered in the Invoice Number field?
The Invoice Number should include OD-SPARC#-next available sequential number (ex. OD-18213-001)
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 Quality Assurance Coordinator do if the eIRB notification is for a study that is not managed by the HCC CTO?
If the study is not managed by the HCC CTO, the Quality Assurance Coordinator must forward the eIRB notification to the OCR PRA team. Only the OCR PRA team should review and issue PRA approval in eIRB for non-HCC CTO managed trials
What documents must be attached when sending the initial coverage analysis request email to Hay Hill?
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?
What report displays items across all protocols that are available to be placed on an invoice, but haven't yet been assigned to an invoice, 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, submit the build request through all steps (1–5) and confirm it appears in the Epic Queue. Within the Epic Queue select the green button to push the calendar from SPARC into Epic.