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.

OnCore entry of Serious Adverse Events (SAEs)

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Since November 2019, CCTO-Safety does not process any Serious Adverse Events (SAEs) for Industry sponsored trials into OnCore. Do not send SAE reports to CCTO-Safety for Industry sponsored trials.

 CCTO-Safety will only process SAEs reports for Investigator-Initiated Trials into OnCore.

The Regulatory SOP and guideline documents have been updated. Also, the SAE CRFs (3 forms) are updated and uploaded. https://med.stanford.edu/ccto/staff-resources/coordinator-corner.html#regulatory

Update on IIT Protocol Template and REDCap Intake

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Adoption of the new protocol template is going well since it’s availability 30 April.  However, we are aware that some IIT studies are still being received or developed on the old template, despite the upcoming deadline of 30 June for acceptance of all new IIT protocol on the old template.  The deadline is extended until 30 July, which is 3 months from the announcement and availability of the new template.  Until 30 July, new IIT protocols submitted on the old template will continue to be referred for a Regulatory consult to insert key aspects of the new template, specifically, alignment to the current SCI Data Safety Monitoring Plan (DSMP) and ClinicalTrials.gov considerations.  After 30 July, submitters will be asked to re-submit on the new template, which will include this information by default.