T14, T42, T90, TU2, S10, C06, UC6, G20, X02, OT1, X01, I01, IP1 IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 Exemption N N Incl: Both Both Provide error if Exemption 7 and/or 8 E New rule NIH, V1.4 and number -8 exemption 7 and/or 8 is are not valid selections CDC, October selected on the Other FDA, 2017 Project Information form AHRQ Release Other and the response to the USU Project this study question, “Is exempt from Federal Regulations is “Yes” IRB review N N Incl Incl: Both Overall If IRB review pending? Is If the answer to E ‘IRB NIH, V1.3 and pending? false and project exempt Review Pending’ CDC, from regulation is No, question is the IRB ‘No’, FDA, IRB approval date and Approval Date and
T14, T42, T90, TU2, S10, C06, UC6, G20, X02, OT1, X01, I01, IP1 IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 and Other Project Exemption number -8 N N Incl: NIH, CDC, FDA, USU V1.4 Both Both Provide error if exemption 7 and/or 8 is selected on the Other Project Information form and the response to the question, “Is this study exempt from Federal Regulations is “Yes” Exemption 7 and/or 8 are not valid selections E New rule October 2017 Release and IRB review pending? N N Incl NIH, CDC, FDA, Incl: V1.3 Both Overall If IRB review pending? Is false and project exempt from regulation is No, IRB approval date and If the answer to ‘IRB Review Pending’ question is ‘No’, the IRB Approval Date and E AHRQ
eSub-validations-draft-09-12-2017.docx