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 studies.
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.