SPCTRM– Stanford/Packard Center for
Translational Research in Medicine

Place a Trial at Stanford

Flow Chart

ENLARGE GRAPHIC


SPCTRM is the single point of contact at Stanford University School of Medicine and Medical Center for industry clinical research professionals.

  1. When the SPCTRM office receives preliminary study information -- for example, a protocol synopsis, schedule of events, investigator/site questionnaire, SPCTRM:
    • identifies and notifies potential principal investigators (PI) about the clinical research study, and
    • will notify faculty whose patient population and research interests coincide with the therapeutic nature of the study.
    • When a faculty physician is interested in learning more about the protocol, s/he will sign the Confidentiality Agreement, complete the investigator questionnaire and return to the sponsor

  2. Sponsor then can contact the prospective PI to provide further study information.

  3. A site initiation visit can be scheduled directly with the PI or through SPCTRM.

  4. PI will meet with a Research Process Manager (RPM) to flow out the protocol and build a study budget.

  5. The budget is negotiated, if needed, and finalized by the RPM.

  6. Budget and contract are sent to the University Office of Sponsored Research (OSR). OSR negotiates the contract terms on behalf of the PI and Stanford University.

  7. Contract is signed.

  8. In a parallel process with OSR, the PI and coordinator process the IRB submission and patient consent, submitting to the Stanford University Human Subjects in Medical Research Administrative Panels Office, known as the IRB (Institutional Review Board).

  9. The IRB logs in the protocol, and assigns a review date, one of three monthly IRB Panel meetings. Generally a protocol submitted early in the month will be reviewed the following month. In a preliminary review, the IRB may suggest some edits to the protocol or consent prior to the formal committee review.

  10. The IRB notifies the PI of project approval the day following the meeting.

  11. Patient enrollment can begin.

 

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