SCI Cancer Clinical Trials Office Blog

News & Updates from the SCI-CCTO

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  

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. 

New SCI SOP – Assenting Pediatric Research Participants

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A new SCI SOP “Assenting Pediatric Research Participants” will be effective on 24 October 2022. 

This new SOP describes the procedure for assenting children (generally 7-17 years old) to research. Please note the parental consent/legally authorized representative (LAR) process is described in the SCI SOP “Consenting Research Participants and Legally Authorized Representatives.” 

Please attend the CCTO All Staff meeting on 20 October 2022 when training will be provided. In addition, training will be provided within CRGs that work with pediatric research participants. 

If this SOP is applicable to your work, please review this SOP prior to the effective date of 24 October 2022 at https://med.stanford.edu/ccto/services/regulatory.html#sops and attest to your mastery of the information in the SOP confirmation form available on the same webpage.

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

Update of SOP Investigator-Initiated Multi-Site Trial Management, Effective 12 September 2022

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The SOP, Investigator-Initiated Multi-Site Trial Management, has been updated (version 5, effective 12 September 2022). The key change includes:

  • Inclusion of procedures required when changing from a previously approved single site trial to a Stanford-led multi-site trial (Section 5.4).

If this is applicable to your work, please review this updated SOP as soon as possible at https://med.stanford.edu/ccto/services/regulatory.html#sops and attest to your mastery of the information in the SOP confirmation form available on the same webpage.

New Consenting SOP

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New SOP “Consenting Research Participants and Legally Authorized Representatives” Effective 12 September 2022

A new SCI SOP “Consenting Research Participants and Legally Authorized Representatives” will be effective on 12 September 2022. 

This new SOP consolidates multiple SCI SOPs that we currently have related to the consenting process. Specifically, the procedures currently addressed in SCI SOPs Informed Consent for Adult, English-speaking Participants (Initial and Re-Consent), Legally Authorized Representative (LAR) in Informed Consent and Remote Consent of Research Participants were included in this single SOP. The goal was to provide all the relevant procedures related to consenting in a single SOP. The procedures are not substantively changed with the exception of greater clarification of consenting participants with impaired decision-making capacity. 

Please review this updated SOP prior to the effective date of 12 September 2022 at https://med.stanford.edu/ccto/services/regulatory.html#sops_guidelines and attest to your mastery of the information in the SOP confirmation form available on the same webpage.

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