Cancer Clinical Trials Office Blog

News & Updates from the CCTO

SRC Protocol Statement of Support (PSOS) Forms Available July 1, 2020

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SRC PSOS forms (initial and renewal) have been streamlined and updated and will be available to download July 1st, 2020.  These updated forms should be used for any studies reviewed from this date onwards.

SRC website:

https://med.stanford.edu/cancer/research/trial-support/src/research-groups.html

Please note there is now only one PSOS form that can be used across all CRGS: We have removed the CRG member list, instead CRG attendee names can now be added to the form.

CRG participants that need to be present for the study review remains the same:

  • Initial PSOS: At least 3 CRG members other than the PI
  • Renewal PSOS: At least 2 CRG members other than PI

The following are the major changes that were made to the SRC PSOS forms:

  • Only 1 PSOS form (initial and renewal) can now be used by all CRGS
  • CRG specific forms have been removed.
  • CRG Attestation: CRG leader/designee signing the PSOS form, will need to provide a rationale related to the importance of the study in the CRG`s study portfolio
  • Initial PSOS has the following updates:
  • Added a question related to the inclusion of underrepresented population
  • Staff resources section updated to include OPAL Score

Reminder From SRC : Completing PSOS Form (Protocol Statement of Support)

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Per the current SRC policy, the minimum annual accrual goal at Stanford needs to be 5 or more. This is applicable for all disease categories that are not rare.

A rare disease is defined as having the incidence rate of 5,000 newly diagnosed cases of any specific cancer per year.

The committee wants to ensure effective utilization of resources that are needed to open a research protocol, hence the requirement.

This is effective immediately. The PSOS templates will be updated soon to reflect this as well. 

If you have any questions or concerns regarding this, please feel free to contact us  at src-office@stanford.edu

SRC Team

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.