Cancer Clinical Trials Office Blog

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>

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>