Study Set-up
Clinical Trial Study Start-up Process
SeRA CT PDRF: Submitting Your Study to CTRMG
The Study Team/PI/Dept uses the CT PDRF to submit industry-sponsored 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.
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Determining When to Use the CT PDRF
The CT PDRF is used to submit an industry sponsored 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.
A clinical trial that involves cancer subjects should be submitted through the Cancer Clinical Trials Office CCTO Intake portal: http://med.stanford.edu/ccto/request.html
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.
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
Choosing the correct Agreement Subtype.
Will industry funding flow through another academic institution and will Stanford contract directly with this institution?
· YES- Subtype = Subcontract
Did Stanford PI conceive the research plan, develop the protocol and if required, serve as sponsor investigator with the FDA and hold the IND or IDE?
· YES - Subtype = PI Initiated Protocol
· NO - Subtype = Sponsor Protocol.
New CT PDRF Introductory Training Module
How to Expedite Study Start Up Process
- Complete IRB submission in parallel or prior to submission of CT PDRF
- Request and provide all unit pricing with CT PDRF submission – such as CTRU, Pharmacy, Lucas Center
- Initiate Medicare Pre-Authorization Process in parallel with CT PDRF and IRB submission (this can take several months to complete). See Resources on CT RMG website: IDE Preauthorization Guidance
NOTE: The IRB does not require 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.
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.
Resources, Policy, and Training
Resources
Training
- Spectrum Research Budgeting and the Workbook Process class
- Updated Coverage Analysis Resources to be posted soon