Project VA exemption number checked or an Exemption number not equal to provide error. ‘E4’, Research 004.3.3 N N Incl : Incl: Multi Y Human Subjects exemption W For Revision and NIH, V1.3 and number number 4 is typically not Resubmission applications, CDC, Related 1-6 allowed on the Overall provide a warning if Overall FDA, Other component unless exemption Human Subject is Yes and AHRQ, Project 4 is selected for all VA Exception code is E4 and all components that include Components with Human Human Subjects. Subject is Yes and Exception code is different than E4 or not any are selected Research IRB 004.4.1 N N Incl : Incl: Both If IRB review pending? Is If the answer to E ‘IRB Review NIH, V1.3 and review false, IRB approval date and question is the Pending’ ‘No’, CDC, Related pending? Human subject assurance IRB Approval Date and FDA, Other number cannot be blank. Human Subject Assurance AHRQ, Project Number must be provided. VA Research IRB and approval Related date Other Project Research IRB and approval Related date Other Project
Project VA exemption number checked or an Exemption number not equal to ‘E4’, provide error. Research and Related Other Project number 1-6 004.3.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For Revision and Resubmission applications, provide a warning if Overall Human Subject is Yes and Exception code is E4 and all Components with Human Subject is Yes and Exception code is different than E4 or not any are selected Human Subjects exemption number 4 is typically not allowed on the Overall component unless exemption 4 is selected for all components that include Human Subjects. W Research and Related Other Project IRB review pending? 004.4.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both If IRB review pending? Is false, IRB approval date and Human subject assurance number cannot be blank. If the answer to ‘IRB Review Pending’ question is ‘No’, the IRB Approval Date and Human Subject Assurance Number must be provided. E Research and Related Other Project IRB approval date Research and Related Other Project IRB approval date
SVS-Validations-Single-and-Multi-Project-April-2015-tracked-PreRelease.docx