Cancer Clinical Trials Office Blog

Effective July 1^st, 2020, all new protocols submitted for SRC review now require:

• CRG Priority Score Form in addition to
• PSOS Form and
• Flow charts (applicable to all interventional trials)

CRG Priority Score Form:

Any protocol submitted to SRC that has a PSOS sign-off date of 1 July 2020 or later must also submit the priority score form.

• Retrospective documentation of any studies approved by the CRG in July 2020 and

Prospective for all studies reviewed by the CRG.

• Studies that undergo review by more than one group or CRG; originating CRG should complete the CRG Priority Score Form and provide to the collaborating group for their review process
• The CRG Priority Form should be reviewed along with the PSOS form at the CRG meetings and signed off by the CRG leader.

This will allow documentation of the process of protocol selection and prioritization at the CRG Level.

• The Initial PSOS Form has been updated to remove redundancies between the Priority score form.

SRC PSOS Forms and CRG Priority Form can be downloaded from theSRC webpage:

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

Submissions for SRC review should be made via CCTO Intake at: https://med.stanford.edu/ccto/request.html

• Please note the Priority score form can be uploaded to the “CRG Priority Score Form” under the section “New Study Request (Document Attachments)” in the redcap CCTO intake application. This is a mandatory field. 
• Please reach out to Sharmila @ ccto-intake@stanford.edu for any technical difficulties.

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

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

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>