024.8.2 N N Incl : Incl: An answer to The Human E New rule PHS Human NIH, F05, Clinical trial Subjects Clinical Subjects 4.0 F30, question is Trial question and F31, required if the must be Clinical FDA, answer to answered if the January Trial (Y/N) Subjects answer to 14,2016 ‘Human F37, is Subjects Release, Update Involved’ ‘Human Form USU F38, "Yes". on the to Existing Rule Involved’ FI2, Other Project (added Information page F99/K00) is "Yes". PHS Human 024.9.2 N N Incl : Incl: If Human The Human E New rule NIH, F05, Subjects Clinical Subjects Subjects 4.0 F30, Trial is No, Phase III and F31, Phase Clinical Trial FDA, III Clinical Trial must be if “No” must be No or the answer to the Phase III F37, NULL Human Subjects January Clinical Form USU F38, Clinical Trial 14,2016 Trial (Y/N) FI2, question is Release, Update “No” to Existing Rule (added F99/K00) PHS Human 024.9.1 N N Incl : Incl: An answer to The Human E New rule NIH, F05, NIH-Defined Subjects Subjects 4.0 F30, Phase III Clinical Phase III and F31, Trial is required Clinical Trial FDA, if the answer to question must be January Subjects answered if the 14,2016 ‘Human Phase III F37, Clinical is answer to the Release, Update Trial’ Clinical Form USU F38, "Yes". Human Subjects to Existing Rule Trial (Y/N) FI2, Clinical Trial (added question is "Yes" F99/K00) PHS Fellowship N N Incl : Incl: Protection of The Protection of E New rule NIH, F05, Human Subjects Human Subjects 4.0 F30, attachment is attachment must Form and F31, required if be included if the
PHS Form Human Subjects Clinical Trial (Y/N) 024.8.2 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, An answer to Clinical trial question is required if the answer to ‘Human Subjects Involved’ is "Yes". The Human Subjects Clinical Trial question must be answered if the answer to ‘Human Subjects Involved’ on the Other Project Information page is "Yes". E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Human Subjects Phase III Clinical Trial (Y/N) 024.9.2 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, If Human Subjects Clinical Trial is No, Phase III Clinical Trial must be No or NULL The Human Subjects Phase III Clinical Trial must be “No” if the answer to the Human Subjects Clinical Trial question is “No” E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Human Subjects Phase III Clinical Trial (Y/N) 024.9.1 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, An answer to NIH-Defined Phase III Clinical Trial is required if the answer to ‘Human Subjects Clinical Trial’ is "Yes". The Human Subjects Phase III Clinical Trial question must be answered if the answer to the Human Subjects Clinical Trial question is "Yes" E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Fellowship Form N N Incl : NIH, 4.0 and Incl: F05, F30, F31, Protection of Human Subjects attachment is required if The Protection of Human Subjects attachment must be included if the E New rule
eSub-validations-draft-08-21-2017.docx