Overview: Study Set-up

How to initiate the study start up process and obtain a SPO

Step 1

Study Team submits all required minimum documents to CT RMG Intake Team.

Required Minimum Documents:

  1. Completed Study Activation Form
  2. Protocol
  3. Sponsor’s Contract with Payment Schedule
  4. If using CTRU services, complete CTRU Budget Builder
  5. For Pediatric and PI-Initiated (Adult & Peds) Studies - Completed Budget & Billing Workbook

OR FOR ADULT STUDIES WITH SHC PROVIDED SERVICES ***NEW PROCESS: Please see Important Change for SHC Budget and Billing Workbook***

Within 1-2 days of receipt, CT RMG Intake Team reviews all documents and forwards to Ankura for Coverage Analysis (CA)

Within 2-3 days, Ankura Consultants review all study documents and will communicate directly with study team to request additional essential documentation required for CA.

- Draft Informed Consent Form

- FDA IND/ IDE documentation, if applicable

- CMS or Noridian documentation, if applicable (device studies)

Once Ankura has received all required documentation, they notify study team and CT RMG Intake by email that their CA has been initiated.

Within 10 business days Ankura will complete and send to study team and CT RMG Intake Initial Draft CA within SHC Modified Workbook.


Step 2

CT RMG Intake Team reviews documents submitted


Step 3

CT RMG Intake Team initiates the study in SeRA, which generates a SPO number.  SPO number is Stanford's unique identifier for a sponsored project.


Step 4

CT RMG Intake Team sends emails:

  • To study team notifying them of SPO number and assigned CT CO & CT RPM. If required, email also requests completion of training and/or PI Waiver Application
  • To sponsor providing guidance on working with CT RMG and notifying them of SPO number and assigned CT CO & CT RPM

NOTE: The IRB does not required a SPO number as part of protocol submission. However, final protocol approval is contingent upon receiving a SPO. RMG uses the SPO as a reference to track the study pre and post Award.


Step 5

CT RMG Intake schedules a Kick Off Meeting with the study team, CT RPM and CT CO.

How to Expedite Study Start Up Process

  1. Complete IRB submission
  2. Submit all required Minimum Documents (see list above), as a complete package, by email to CT RMG Intake Team.  Include PI, Department, and Sponsor in the subject line

 

How does CT RMG assign a CT RPM and CT CO to a clinical trial?

CT COs and CT RPMs have Department Assignments.

However, studies will be triaged when necessary to manage workload across the CT RMG team and accommodate vacations or sick leave.

Resources, Policy, and Training