SCI Cancer Clinical Trials Office Blog

News & Updates from the SCI-CCTO

Investigational Product Return Documentation Update

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The process for documenting investigational product accountability (ie pills/pill bottles) has been updated. Effective 6/2/23, you will no longer provide IDS with a copy of the “Investigational Product Return” form when returning IP to IDS. You will instead use the updated Investigational Product Custody Smartphrase Template to document participant training, chain of custody and drug accountability.

The updated document can be found  in Coordinator Corner:

  • On Study > Investigational Pharmacy and Investigational Product > Investigational Product Custody Smartphrase Template (Form/Logs) – May 18, 2023

Updated ITA Harmonized Nursing Inservice Form

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The harmonized nursing in-service template has been updated to streamline nursing in-services in the ITA.  Read associated memo for additional info.

The updated form and memo can be accessed in Coordinator Corner:

  • Study start-up/close out > ITA/CTRU/Inpatient > Harmonized Nursing Inservice Template (Form/Log) – 14Mar2023
  • Study start-up/close out > ITA/CTRU/Inpatient > Memo- Updated Nursing Inservice Template (Guideline)14Mar2023

Spectrum publishes memo that addresses study-specific clinical laboratory reference range lists

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In November 2022, Stanford Medicine Clinical Laboratory announced that study-specific laboratory reference ranges would not be provided. To support and elaborate on the information in the November memo, Spectrum published MEM-011 Clinical Laboratory Reference Ranges. This memo may be provided to study sponsors, as needed, to explain that study-specific clinical laboratory normal range lists are not provided. SU approval is not required to share this memo outside Stanford. It is a good practice to make study sponsors aware of this information in the study start-up stage. 

Updated and New Guidelines posted on CCTO Coordinator Corner

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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.

New SOP “Corrective and Preventive Action Plan” Effective 1 February 2023

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A new SCI SOP “Corrective and Preventive Action Plan” is effective on 1 February 2023. 

This new SOP describes the process for developing, managing and evaluating a corrective and preventive action (CAPA) plan. Please refer to this SOP any time you are involved in the CAPA process. 

If this SOP is applicable to your current work, please review this SOP prior to the effective date of 1 February 2023 at https://med.stanford.edu/ccto/services/regulatory.html#sops and attest to your mastery of the information in the SOP confirmation form available at the bottom of the same webpage.  

An updated version of the SCI CAPA template is available on CCTO Coordinator Corner. Please use this document moving forward for all CAPAs unless another form is required by an external party. 

Questions regarding this new SOP should be directed to DSMC-Quality@stanford.edu