SCI-CTO Guideline Update: Opening a Single-center Investigator-Initiated Trial (IIT) 

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The SCI-CTO guideline “Opening a Single-center Investigator-initiated Trial” version 9 is released and available on Coordinator Corner (Study Start-up/Close Out tab, Overview section). The document, which describes the activities required in the development and activation of a single-center Stanford IIT, has undergone extensive changes from the prior version. 

Scope: Single-center Stanford IITs

Training: 

  • Staff directly involved in opening and managing IITs should review the document thoroughly in order to apply the information to your work.
  • Staff not directly involved in opening and managing IITs should review the document for awareness.

Please direct questions to DSMC-Quality@stanford.edu.

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.