SCI Cancer Clinical Trials Office Blog

The following guidelines are posted on CCTO Coordinator Corner. Please review these guidelines for awareness and as they are applicable to your work. Questions about any of these processes may be directed to DSMC-Quality@stanford.edu.

Opening an Industry-Sponsored Trial

This updated guideline is a tool to guide the process for activating an industry-sponsored trial. Version 9 is updated to include current information for this process. This guideline may be found in Coordinator Corner under the Start-up/Close-out tab in the Overview section.

Participant Payments

This new guideline is a tool to guide the process for setting up systems for and managing participant payments for both reimbursements and stipends. This guideline may be found in Coordinator Corner under the On-Study tab in the Finance section. 

Transitioning Coordinators 

This updated guideline is a tool to guide the process for transitioning the management of a study from one coordinator to another. Version 5 is updated to include the current information for this process. This guideline may be found in Coordinator Corner under the Regulatory tab in the Regulatory Documentation section.

SHC/LPCH Clinical Lab leadership communicated that laboratory reference ranges would no longer be provided in lists of normal ranges. It is important to communicate this with sponsors of new studies in the start-up stage so there are no surprises. It may also be necessary to communicate with sponsors of ongoing studies that expect these lists to be provided. The memo may be shared with sponsors upon request. 

See the memo from Dr. Kong dated 10 November 2022 on Coordinator Corner in the Study Start up/Close Out tab, Clinical Lab section at https://med.stanford.edu/ccto/staff-resources/coordinator-corner.html

Please note that current SHC/LPCH laboratory licensure and other lab-related documentation are available at https://stanfordlab.com/test-directory/licensure.html. OnCore also has a repository of current and historic licensure and lab director CVs. To navigate to these documents in OnCore, select PC Console and type “lab-docs” into the “select protocol” field. 

A study team meeting template is now available on Coordinator Corner. It is located on the Regulatory tab in the Miscellaneous section at the bottom of the page. Study teams are strongly encouraged to use this tool for their team meetings.

Study team meetings are a very important mechanism to support the conduct of high-quality clinical trials. They are crucial for good communication between all team members, specifically to review the status of the trial, plan for upcoming activities and identify and escalate any issues. A comprehensive standing meeting agenda can ensure all topics are covered at each meeting. Documenting meeting notes helps with communication and tracking of actions and progress. It also helps with demonstrating principal investigator oversight based on their active engagement in those meetings.

Please use this template for your meetings with appropriate adaptations for your study-specific and team needs.

Many thanks to the BMT/CCT team who developed the tool from which this template was adapted.