SCI Cancer Clinical Trials Office Blog

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  

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 

The SOP, Determination of Participant Eligibility in Clinical Trials, has been updated (version 2, effective 25 July 2022) with key changes including: 

1) allowance of Advance Practice Providers (APPs [nurse practitioners, physician assistants]) who are investigators on your trials to be one of the 3 eligibility reviewers, 

2) clarify that an investigator must document subjective eligibility criteria that require clinical judgement or interpretation (e.g., life expectancy of a particular duration) and 

3) change the number of independent reviewers of eligibility in low risk interventional studies.

If you have not already done so, please review this updated SOP prior to the effective date of 25 July 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.

Please note that the current version of the SOP (2016), along with V2 effective 25 July 2022, will co-exist on the CCTO website until the effective date of V2 so be careful to access, review and master V2. 

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