T37, K12, , Other Project D43, D71, Plan USU Information form U2R is ‘Yes’. PHS Data N N Incl: Required if The Data Safety E Update to “Yes” existing rule 398 Safety NIH, is selected as Monitoring Plan 2.0, (excluding Monitoring the answer to attachment is 4.0 v4.0), for Plan the required if the “Clinical and Forms E, USU question response to the Trial?” October on the PHS Clinical Trial Release Cover Page question on the Supplemental Cover Page Plan Form Supplement is “Yes” PHS Vertebrate N N Incl: Incl: Required A Vertebrate E Update to T01, T02, existing rule 398 Animals NIH, Vertebrate Animals T03, T14, message Animals is true attachment must T42, T90, on Other Project be included if T90/R90, Update to FDA, Information form the response to TU2,T15, existing rule within the same the Vertebrate T32, T34, (removed component Animals Used T35, T36, KM1) T37, K12, , Question on the D43, D71, Plan USU Other Project U2R Information form is ‘Yes’. PHS Select 398 Agent Research
Plan , USU T37, K12, D43, D71, U2R Other Project Information form is ‘Yes’. PHS 398 Plan Data Safety Monitoring Plan N N Incl: NIH, USU 2.0, 4.0 and 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 Update to existing rule (excluding v4.0), for Forms E, October Release PHS 398 Plan Vertebrate Animals N N Incl: NIH, FDA, , USU Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R 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 Select Agent Research
eSub-validations-draft-10-10-2017.docx