Process For Clinical Trials
Welcome to the Coverage Analysis Process page for Clinical Trials.
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.
Collects and uploads all essential documents.
Reviews protocol procedures and considers study logistics (ie. use of CTRU).
Completes and routes CT PDRF in SeRA.
FAQs for the CT PDRF.
Submits protocol to IRB.
Overview: For all clinical research that meets Stanford's Industry Sponsored Clinical Trial (CT) criteria, Study Team completes and routes a CT PDRF in SeRA. To follow the expedited CT study start up process, protocol is also submitted to IRB at the same time.
Responds to CTRPMA if essential documents missing from CT PDRF.
Downloads and reviews study documents from SeRA.
Reviews comments provided by CT RPM.
Sends an email to notify Study Team that CA review has begun (timeline to complete 10 business days)
Reviews CT PDRF for completeness and if ncessary, returns CT PDRF to collect missing details.
Provides comments to Ankura to align CA Billing Grid with Sponsor's Payment Schedule.
Initiates CA transaction in SeRA.
Overview: CT RMG Intake team reviews the CT PDRF details and study documents. Missing information is requested from study team. CTRPM initiates a CA transaction in SeRA with notes to align CA Billing Grid (BG) with budget exhibit. Ankura reviews study documents downloaded from CT PDRF and sends an email to notify Study Team that CA review has begun (timeline to complete 10 business days).
By email provides feedback to Ankura (cc: CT RPM) via Study Team Review Checklist within BG:
- Confirms Billing Designation
- Validates hospital service billing codes and number of occurrences
- Replies to questions (see red text) posed by Ankura
Prepares CA Billing Grid (BG) that lists hospital services with identifiable codes.
Color codes all procedures with billing designations at each protocol defined timepoint.
Flags in red text questions for Study Team.
Emails Draft CA to study team (cc: CT RPM).
Updates BG based on Study Team's feedback.
Returns BG to Study Team for approval.
Facilitates Study Team’s timely review of CA Billing Grid (BG).
Reviews BG in comparison to Sponsor's Payment Schedule:
- number of occurrences
- invoiced procedures
If necessary, facilitates a pre-KO meeting to discuss CA in person with Study Team and Ankura.
Overview: Based on protocol's Schedule of Events, Ankura prepares Draft CA Billing Grid (BG) that lists hospital services with identifiable billing codes and uses color coded billing designations for each service at each timepoint required per protocol. Also, within the BG, Ankura uses red text to flag questions directed at Study Team. CT RPM facilitates Study Team's review of BG and compares BG to Payment Schedule. Study Team reviews and provides feedback to Ankura within the BG's Study Team Review Checklist.
Uses the Study Team Review checklist in BG to confirm all procedure line item details by flagging them as green.
Emails (cc: PI & CT RPM) Draft CA to Ankura with statement confirming that PI has reviewed and approved Draft CA.
Confirms all procedure line items flagged as green in Study Team Review Checklist in BG.
Issues Initial Approved CA.
Overview: After Study Team has reviewed and confirmed details in BG, by using the Study Team Review checklist in BG and flagging all protocol procedures line items as green, they email (cc: PI & CT RPM) Draft CA to Ankura along with a statement confirming PI has reviewed and approved Draft CA. Ankura issues Initial Approved CA.
If requested, updates BG to align cost estimate in RPS form with study budget.
Prepares draft Internal Budget based on Initial Approved CA.
Prepares budgeting questions re. BG to address during KO meeting.
Uses BG to request changes and align cost estimate in RPS with budget.
Finalizes Internal Budget and Payment Schedule.
Negotiates budget with Sponsor.
Overview: Based on Initial Approved CA, CT RPM develops draft Internal Budget in preparation for discussion at KO meeting.
If necessary, CT RPM requests changes to BG to align cost estimates in Research Participant Services (RPS) Form with Payment Schedule. Ankura makes requested changes to BG. CT RPM negotiates budget with Sponsor and uploads Final Budget into CT PDRF in SeRA.
Submits eProtocol modification if Ankura's CA Harmonization requires a revision to ICF.
Reviews final approved Payment Schedule and ICF to confirm alignment with CA.
Notifies study team and CT RPM if any changes required to BG, ICF or Payment Schedule.
Emails study team (cc: CT RPM) Final Approved CA workbook to study team (cc: CT RPM) and uploads it to Award transaction in SeRA.
Issues Award Acceptance Notification (AAN) in SeRA (cc: Ankura).
Follows up with Study Team and/or Sponsor if Ankura's CA Harmonization requires a budget revision.
Overview: Clinical Trial Contract Officer (CT CO) issues AAN in SeRA (cc: Ankura). To ensure billing compliance, Ankura reviews alignment or "harmonization" of Payment Schedule included within executed Clinical Trial Agreement (CTA), IRB approved Informed Consent (ICF) and CA Billing Grid. Ankura notifies Study team and CT RPM if any changes are required to Payment Schedule, ICF or BG based on their review. Ankura emails Final Approved CA workbook to study team (cc: CT RPM) and uploads it to Award transaction in SeRA.
After Notice of Award (NOA) has been issued, obtains PTA.
Completes the Study Account Request Form in Final Approved CA workbook.
Emails Final Approved CA workbook to PFS to request SHC study account/98 account.
Overview: After the Notice of Award (NOA) has been issued, Study team obtains PTA from Dept Finance Manager and completes the Study Account Request Form in Final Approved CA workbook.
To request a SHC study account/98 account, Study Team emails Final Approved CA workbook to PFS: DL-StudyWorkbook@stanfordhealthcare.org.