CT PDRF

Determining When to Use the CT PDRF

A clinical trial that involves cancer subjects should be submitted through the Stanford Cancer Institute's - Clinical Trials Office (SCI-CTO).
 
Please note CT PDRF is a distinct process separate from SoM Proposal Intake Form (PIF) which is used for all sponsored projects except industry-funded CTs.
 
The CT PDRF is used to submit an industry-funded clinical trial (CT) to CT RMG. This subset of clinical research studies qualify for the University’s clinical trial indirect cost rate of 28% by meeting 4 requirements or criteria.
 
When a clinical research study does not meet all 4 criteria, the study is assigned to a Grant RPM in SeRA by study team’s submission of a Proposal Intake Form (PIF) in SeRA.
 
The CT PDRF within the Stanford Electronic Research Administration (SeRA) system captures required compliance information, including Conflict of Interest, export control, the European General Data Protection Regulation (GDPR), PI training, as well as the project’s financial details. A clinical trial contract may not be signed until the CT PDRF has been fully routed and approved.
 
The CT Proposal Development and Routing Form (CT PDRF) within the Stanford Electronic Research Administration (SeRA) system facilitates and tracks the research administration process for all CT proposals:
- initiates CT RMG Intake process
- provides information necessary for proposal review and endorsement by Stanford University
- documents required approvals to accept a budget for an industry-initiated CT or to submit a budget for an Investigator-Initiated CT.
 
The Principal Investigator’s approval of the CT PDRF provides certifications required by government agencies and confirms an agreement to comply with Stanford and sponsor policies
- Approval from other Stanford faculty who will devote effort to the project
- Departmental approvals confirm financial commitments made in a proposal and that stated personnel and facilities are available to carry out the project
- Institutional Official (IO) approval
- Other approvals may be required depending on policies, processes and case-specific circumstances

CT PDRF Introductory Training Module

Initiating the CT PDRF in SeRA

  • Go to sera.stanford.edu/; you will be taken to your Dashboard 
  • Use the “Start Proposal” button on the top right hand side of the dashboard 
  • Select “SoM Industry Clinical Trial” 
  • Agreement Type will default to Industry Clinical Trial 
  • Select Agreement Subtype from drop-down selections 
  • Select “Start” to create the CT PDRF record

Frequently Asked Questions

Frequently Asked Questions about the CT PDRF

Please read carefully to expedite the Intake Process.

Resources