study are conclusively relatedto the intervention and notother factors. Therefore, theirveri昀椀cation is leaned on heavilyduring regulatory visits andinspections. See this excerptfrom an FDA Warning Letteras proof of the importance ofverifying eligibility: “Enrollmentof subjects who do not meeteligibility criteria…jeopardizesubject safety and welfare andcompromise the validity andintegrity of the data collected atyour clinical research site.”The checklist used should bestudy-speci昀椀c, matching thecurrent version of the protocol,and listing all criterion separately(see Diagram 6 on next page).Each criterion should be veri昀椀edprior to the performance ofany study-speci昀椀c activities(including randomization) bydirect comparison with sourcedocumentation (e.g., pathologyor laboratory test results,physical exams, outside records).In other words, it is not enoughto rely on “yes” and “no” checkboxes with a general “blanket”statement such as, “The subjectdoes/does not meet theinclusion or exclusion criteriaoutlined in the protocol.”You must have proof to con昀椀rmeach item on the checklist.As with the completion ofthe ICF, the staff memberreviewing subjects for eligibilityand completing this checklistshould be quali昀椀ed, delegated,and trained. Depending onthe clinical research site andSponsor, the checklist mayhave multiple signature linesas a “check and balance”multi-layer validation system(i.e., coordinator, nurse,Investigator, etc.). Often, theclinical investigator is requiredto sign/date the checklist forcon昀椀rmation of eligibility, as wellas documentation of oversight.Diagram 4Diagram 58SOCRA SOURCE © November 2024843
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