SCI Cancer Clinical Trials Office Blog

News & Updates from the SCI-CCTO

Renewal PSOS Forms Updated and Posted

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All renewal PSOS forms have been updated to streamline the renewal form with the essential elements reviewed by SRC at the time of renewal review and to remove redundant questions.

Please download and use these updated forms at time of renewals.

PSOS forms can be located at: http://med.stanford.edu/cancer/research/trial-support/src/research-groups.html

The key elements reviewed during SRC Renewal:

  1. Accrual: Projected versus actual accrual
  2. Scientific merit: (Additional question (#1) has been added for studies open for 5 or more years)
  3. Interim Analysis for IITs: Completed or not as stated in protocol

Which studies require SRC Renewal:

Annual renewal by SRC is required for all Open to enrollment studies. Please note that for rare disease, pediatric trials, and non-interventional studies, SRC Renewal is not required. The PI will be notified by the SRC approx. 3 months prior to when the study is up for renewal.

If you have any questions or concerns, please contact SRC at src-office@stanford.edu

SRC Protocol Statement of Support (PSOS) Forms Update

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Both Initial and Renewal PSOS forms have now been updated to include two additional questions:

  1. Has PI completed Annual Clinical Research training?
  2. Does PI have any overdue clinical trials.gov reporting?

Since we have received many inquiries as to what can be reported as Annual PI training, here are a few examples:

For more details, … Full Story>

New Endocrine Clinical Research Group

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The Endocrine Clinical Research Group has recently been created, with Dr. Pamela Kunz serving as the CRG leader and Ben Priestley as the Clinical Research Manager. The GI Neuroendocrine flowchart has now moved to the Endocrine group, and several other new flowcharts have been created.

You can view the PSOS documents and flowcharts for the Endocrine group at the following link: http://med.stanford.edu/cancer/research/trial-support/src/research-groups.html

For any questions regarding the Endocrine CRG please contact Ben.

SRC Updates – August 2017

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The following study types no longer require SRC Renewal:

  • Pediatric studies,
  • Rare disease studies, and
  • Non-interventional studies.

Coordinators do not need to submit Renewal Protocol Statements of Support (PSOS) for these studies.

You will no longer receive a signed hard copy of SRC approval/renewal letters. The email notification from SRC-office will be the only communication moving forward.

For information on how to verify whether your study is a rare disease or non-interventional, … Full Story>