Have you read the Appendix A: Eligibility Checklist description in your protocol? Did you know these must be completed fully with source records filed for every eligibility criteria? The study team also should be documenting in the pt. record the process of eligibility verification as part of keeping complete and adequate case histories required by federal regulations. If you are not doing this, you are not only deviating from your IRB approved protocol but are also being noncompliant with our SOP for confirmation of eligibility.
This checklist must match any inc/exc sections in the body of your protocol exactly and must match the eProtocol submission as well. Ensure that version information is present for every eligibility checklist used and that all criteria match.
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