Industry-Funded Clinical Trial (CT) Study Start-up Process

CT PDRF: Submitting a CT to CTRMG

The Study Team/PI/Dept uses the CT PDRF in SeRA to submit industry-funded clinical trial (CT) studies for central office administrative review by CT RMG and to initiate the Clinical Trial Agreement (CTA) and budget negotiation processes. The CT PDRF also records the PI and Department approvals, as well as any financial interests disclosed by investigators. The CT RPM uses the information from the CT PDRF to initiate Coverage Analysis, when required by SHC, and develop a budget for submission to and negotiation with sponsor. Finally, the CT PDRF results in a parallel review by the CT Contract Officer, who negotiates contract terms and conditions.

Roles & Responsibilities

PI/Department CT RMG
  • When required, completes PI Waiver package
  • Collects costs from all service units involved in the study (CTRU, Pharmacy, Lucas Center, etc.)
  • Completes the CT PDRF, including upload of minimum documents
  • Discloses any financial interests via a link to OPACS in the CT PDRF as required by Stanford's Conflict of Interest policy
  • Routes CT PDRF for approvals
  • Submits protocol to IRB
  • When required, reviews and approves Coverage Analysis
  • Attends Kick-Off Meetings
  • Approve final budget 
  • Partner with CT RMG when requested to resolve issues during negotiations
  • Partner with CT RMG to ensure ICF matches what has been agreed upon in agreement.
  • Reviews information in the CT PDRF and communicates missing  requirements to PI/Dept (PI waivers, IDE Pre-Auth, other pricing or clinical study related information)
  • When required, requests Coverage Analysis
  • Sets up Kick-off Meeting
  • Prepares, negotiates, and finalizes budget
  • Redlines, negotiates, and executes contract

How to Expedite Study Start Up Process

  1. Complete IRB submission in parallel or prior to submission of CT PDRF
  2. Early in study start-up process, request pricing for services (i.e. CTRU, Pharmacy, Lucas Center) and include within CT PDRF submission.
  3. For IDE studies, initiate Medicare Pre-Authorization Process (this can take several months to complete) in parallel with CT PDRF and IRB submission. See Resources on CT RMG website: IDE Preauthorization Guidance

NOTE: The IRB does not require a SPO number as part of eProtocol submission. However, as soon as you have a SPO for the project it should be added to the Funding section in eProtocol. This will link the SeRA record (funding source) with the proper study in eProtocol. 

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

CT COs and CT RPMs have Department Assignments.

Studies will be triaged when necessary to manage workload across the CT RMG team and accommodate vacations or other absences.