Project T36, Related Other Project either a PHS Inclusion Enrollment Report Updated K12, form, but has not selected either with an Enrollment Type = "Planned" or a Trigger and T37, validations the PHS Inclusion Enrollment PHS Inclusion Enrollment Report with D71, (May 2016 Report with an enrollment Type = Delayed Onset = Yes as part of the D43, Release) or PHS Inclusion application. “Planned” U2R, Enrollment Report with Delayed T01, Onset = as part of the T02, “Yes” T03, application. T14, T42, T90, T90/R90, NOTE: Training Component of a TU2, Complex should be excluded S10, from this rule. C06, UC6, G20, X02, OT1, X01, I01, IP1 IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 004.4.1 N N Incl : Incl: Both E Research IRB review If IRB review pending? Is false If the answer to ‘IRB Review Pending’ NIH, V1.3 and pending? and project exempt from question is the IRB Approval Date ‘No’, CDC, Related regulation is No, IRB approval and Human Subject Assurance Number FDA, Other date and Human subject must be provided. AHRQ, Project assurance number cannot be VA blank. Research IRB approval and date Related Other Project
Project T36, K12, T37, D71, D43, U2R, T01, T02, T03, T14, T42, T90, T90/R90, TU2, S10, C06, UC6, G20, X02, OT1, X01, I01, IP1 IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 Related Other Project form, but has not selected either the PHS Inclusion Enrollment Report with an enrollment Type = “Planned” or PHS Inclusion Enrollment Report with Delayed Onset = “Yes” as part of the application. NOTE: Training Component of a Complex should be excluded from this rule. either a PHS Inclusion Enrollment Report with an Enrollment Type = "Planned" or a PHS Inclusion Enrollment Report with Delayed Onset = Yes as part of the application. Updated Trigger and validations (May 2016 Release) 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 and project exempt from regulation is No, 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