T03, Enrollment Type = "Planned" or a PHS T14, "Planned" or PHS Inclusion Enrollment T42, Inclusion Enrollment Report with Delayed T90, Report with Delayed Onset = Yes as part of Onset = as part of the application “Yes” the application TU2, S10, C06, UC6, G20, NOTE: Training X02, Component of a OT1, Complex should be X01, excluded from this rule. I01, IP1 , IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 Exemption N N Incl: Excl: Both Provide Warning if Human Subjects are W NIH, T15, and number 1-6 Planned Enrollment involved but no Planned to CDC, and T32, exclude Report form is not part of Enrollment Report(s) for FDA, after T34, version the application when HS inclusion has been AHRQ T35, 1.4 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 and Other Project Exemption number 1-6 N N Incl: NIH, CDC, FDA, USU and after 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 to exclude version 1.4 AHRQ
eSub-validations-draft-07-12-2018.docx