T03, Enrollment Type = "Planned" or a PHS in T14, "Planned" or PHS Inclusion Enrollment T42, on Inclusion Enrollment Report with Delayed T90, March Report with Delayed Onset = Yes as part of 11th Onset = as part of the application “Yes” the application TU2, Updated S10, Trigger C06, and UC6, G20, NOTE: Training X02, Component of a message OT1, Complex should be (May X01, excluded from this rule. 2016 I01, Release) IP1 , IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 Exemption N N Incl: Incl: Excl: Both Provide Warning if Human Subjects are W May 2016 NIH, V1.3 T15, and number 1-6 Planned Enrollment involved but no Planned Release CDC, T32, Report form is not part of Enrollment Report(s) for FDA, T34, the application when HS inclusion has been AHRQ T35, Other = Y and Exemption not included. USU T36, Project E4 K12, T37, Note: Training D71, D43, component of a complex U2R, should be excluded from T01, this rule. T02, T03,
T03, T14, T42, T90, TU2, S10, C06, UC6, G20, X02, OT1, X01, I01, IP1 , IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 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. "Planned" or a PHS Inclusion Enrollment Report with Delayed Onset = Yes as part of the application in on March 11th Updated Trigger and message (May 2016 Release) and Other Project Exemption number 1-6 N N Incl: NIH, CDC, FDA, USU Incl: V1.3 Excl: T15, T32, T34, T35, T36, K12, T37, D71, D43, U2R, T01, T02, T03, Both Provide Warning if Planned Enrollment Report form is not part of the application when HS = Y and Exemption not E4 Note: Training component of a complex should be excluded from this rule. Human Subjects are involved but no Planned Enrollment Report(s) for inclusion has been included. W May 2016 Release AHRQ
eSub-validations-draft-09-12-2017.docx