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  

Laboratory Reference Ranges 

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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. 

Update to Guideline for SAE Reporting for Investigator-Initiated Trials

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The Guideline for SAE Reporting for IITs has been updated (version 5, 12 December 2022). If you work on Stanford IITs, please review this guideline in detail to understand how to manage SAEs that occur on these trials. 

If you have questions about the CCTO SAE form or reporting process, please contact CCTO-Safety@stanford.edu. If you have questions about regulatory requirements for safety reporting, please contact CCTO-Regulatory@stanford.edu. Any other questions should be directed to DSMC-Quality@stanford.edu. 

Study Team Meeting Template is now available – Please Use this Tool!

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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.

Updates to CCTO Coordinator Corner

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A list of recent updates to various documents in CCTO Coordinator Corner (CC) are provided here. Please review applicable updated documents. In addition, many broken links have been corrected in various documents. 

Thank you to those of you who have submitted update requests. These requests are actively reviewed and managed by the Quality Systems for SOPs and Guidelines (QSSG) committee. Keep submitting your feedback at the link on CC so we can keep these documents as valuable resources for our work!

Specific process questions may be routed to DSMC-Quality@stanford.edu.