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. Study Protocol
  3. Sponsor’s Contract with Payment Schedule
  4. Budget and Billing Workbook (be sure to complete Research Participant Services (RPS) form and Routine Care Services form)
  5. Initiate IRB submission
  6. If using CTRU, complete CTRU budget  

Within 1-2 days of receipt of required minimum documents, the CT RMG Intake Team reviews all documents for completeness, assigns the study to a CT RPM and a CT CO and initiates a study in the Stanford Electronic Research Administration system, also known as SeRA.

Please submit completed required minimum documents in a single submission to CT RMG Intake Team. CT RMG Intake Team places incomplete submissions on hold and notifies the study team via email. 


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

The IRB does not require a SPO number as a part of protocol submission.  However, final protocol approval is contingent upon adding the SPO number to the protocol.

RMG uses the SPO number as a reference to track the study pre and post award.

CT RMG Intake Team sends emails

  • To study team notifying them of SPO number, and assigned CT CO and CT RPM.  If applicable, requests completion of compliance training and/or PI waiver
  • To sponsor providing guidance on working with CT RMG and notifying them of SPO number, and assigned CT CO and CT RPM. 

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, as a complete package, by email  to CT RMG Intake Team with PI, Department, and Sponsor in the subject line.

Required Minimum Documents:

  • Completed Study Activation Form (request “Budget Finalization” Kick Off Meeting)
  • Study Protocol
  • Sponsor’s Contract with Payment Schedule
  • Budget and Billing Workbook (be sure to complete RPS form and Routine Care Services form)
  • If using CTRU, complete CTRU budget

 

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.

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