Coverage Analysis
Process For Grants
Welcome to the Coverage Analysis Process page for Grants.
Click on the plus sign to expand a step. An Overview provides a summary description. Click on the flip cards to learn more about the role you play in the Coverage Analysis process.
Study Team
Study Team:
Collect all essential protocol documents.
Review protocol procedures and considers study logistics (i.e., use of CTRU).
At Just In Time (JIT), submit protocol to IRB.
Huron
Huron Team:
Receive weekly protocol report of submitted protocols that identify SHC as the study location.
Within report, identify grant funded studies.
Upload protocol report into MS Teams portal for RMG Director review.
Central Office
RMG Director:
Review protocol report and identify all studies in scope for CA and assign the RPM contact for each study.
Assign report back to Huron in MS Teams.
Overview: At Just In Time (JIT), Study Team submits protocol to IRB. On a weekly basis, Huron sends to RMG Director a report of protocols that were submitted to IRB over the past 7 days that identify SHC as the study location. RMG Director reviews report to confirm grant-funded studies (including subcontracts) in scope for CA and assigns RPM before sending report back to Huron within 5 business days.
Study Team
Study Team:
No action required.
Huron
Huron Team:
Download essential study documents (protocol, ICF, budget exhibits etc.) from eProtocol and SeRA.
Send email to notify PI/study team and the assigned RPM that the study requires CA. If applicable, request from study team missing required study documents or information to complete CA.
Central Office
RMG Director:
No action required.
Overview: Huron completes intake process by downloading essential study documents from eProtocol and SeRA, notifying PI/study team and assigned RPM that the study requires CA, and if applicable, requesting from study team any missing study documents or information to complete CA.
Study Team
Study Team:
See Spectrum website to access CA training videos in STARS to learn more about the CA review process.
Receive email from Huron with Initial CA workbook(s) which is also uploaded into SeRA Award transaction.
Review CA Billing Grid:
-Confirm Billing Designation
-Validate hospital service billing codes and number of occurrences
-Reply to questions (red text box) posed by Huron.
Reply to Huron’s email (cc RPM) either to confirm PI’s approval of CA or to return CA with feedback to Huron requesting revisions.
Huron
Huron Team:
Within approximately 10 days, by email and by upload to SeRA provide Initial CA (cc assigned RPM) to the PI/Study Team for their review and approval.
If revisions requested by study team/PI, review and if necessary, follow up to discuss further.
Central Office
RMG Director:
If needed, facilitate meeting between Huron and PI/Study Team to confer on CA.
Overview: Within approximately 10 days, Huron provides the PI/Study Team with the Initial CA by email (cc assigned RPM) and uploads workbook(s) to SeRA record. Study team reviews CA and if required, provides feedback to Huron requesting revisions within workbook prior to confirming with Huron PI’s approval of CA by email.
Study Team
Study Team:
If necessary, work with RPM to address any budget gaps.
Huron
Huron Team:
No action required.
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Central Office
Overview: RPM confirms financial feasibility based on alignment between CA and proposed study budget. RPM collaborates with the PI/study team and if necessary, with the Sponsor, to adjust the Award budget if the clinical care costs identified as research in the CA exceed the estimates in the study’s proposed budget. |
Study Team
Study Team:
Once the study budget and the CA are aligned, document PI’s approval of the CA on the Investigator Review tab within CA workbook and email the final version to the RPM.
Huron
Huron Team:
No action required. |
Central Office
RPM:
| Update the QCT tab to “Final Harmonized CA Workbook”, password protects Billing Grid tab and save copy of workbook(s) as “Final” in the file name. |
Upload the Final CA workbook(s) to the SPO record in SeRA.
Overview: After PI’s approval of CA is documented within workbook(s) and CA is harmonized with the budget, RPM updates status of CA to “Final Harmonized CA Workbook” within the QCT tab. This version of workbook with file name including “Final” is uploaded by RPM within Award transaction in SeRA.
Study Team
Study Team:
After Notice of Award (NOA) has been issued, obtain PTA. Download Final CA workbook from SeRA. Complete Study Account Request Form. Email Final CA workbook to PFS to request SHC study account/98 account. |
Huron
Huron Team:
No action required.
Central Office
RPM:
No action required.
Overview:
Study team downloads Final CA workbook from SeRA, completes Study Account Research form and then |
sends workbook by email to PFS to request SHC study account/98 account.