PHS Human 014.7.1 N N Incl: Incl: Both Required if Human A Human Subjects E Update to existing T01, T02, T03, rule 398 Subjects NIH, Subjects is on the attachment must be ‘yes’ T14, T42, T90, (removed KM1) CDC, Other Project Info form included if the T90/R90, FDA, within the same response to the TU2,T15, T32, Training AHRQ component Human Subjects T34, T35, T36, question on the Other T37, K12, D43, Plan Project Information D71, U2R form is ‘Yes’. PHS Data Safety N N Incl: Excl: Both Required if is The Data Safety E Forms D, March “Yes” V2.0 2016 Release 398 Monitoring Plan NIH, selected as the answer Monitoring Plan AHRQ to the attachment is required “Clinical Trial?” question on the PHS if the response to the Training Cover Page Clinical Trial question Supplemental Form on the Cover Page Plan Supplement is “Yes” PHS Vertebrate 014.8.1 N N Incl: Incl: Both Required Vertebrate A Vertebrate Animals E Update to existing T01, T02, T03, rule message 398 Animals NIH, Animals is true on attachment must be T14, T42, T90, CDC, Other Project included if the T90/R90, Update to existing FDA, Information form within response to the TU2,T15, T32, rule Training AHRQ the same component Vertebrate Animals T34, T35, T36, (removed KM1) Used Question on the T37, K12, D43, Plan Other Project D71, U2R Information form is ‘Yes’. PHS Select Agent 014.9 398 Research Training Plan
PHS 398 Training Plan Human Subjects 014.7.1 N N Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Both Required if Human Subjects is ‘yes’ on the Other Project Info form within the same component A Human Subjects attachment must be included if the response to the Human Subjects question on the Other Project Information form is ‘Yes’. E Update to existing rule (removed KM1) PHS 398 Training Plan Data Safety Monitoring Plan N N Incl: NIH, AHRQ Excl: V2.0 Both Required if “Yes” is selected as the answer to the “Clinical Trial?” question on the PHS Cover Page Supplemental Form The Data Safety Monitoring Plan attachment is required if the response to the Clinical Trial question on the Cover Page Supplement is “Yes” E Forms D, March 2016 Release PHS 398 Training Plan Vertebrate Animals 014.8.1 N N Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Both Required Vertebrate Animals is true on Other Project Information form within the same component A Vertebrate Animals attachment must be included if the response to the Vertebrate Animals Used Question on the Other Project Information form is ‘Yes’. E Update to existing rule message Update to existing rule (removed KM1) PHS 398 Training Plan Select Agent Research 014.9
eSub-validations-draft-9-14-2016.docx