024.7.1 N N Incl : Incl: An answer to The Human E New rule PHS Human NIH, F05, Human Subjects Subjects Subjects 4.0 F30, Involvement Involvement and F31, Indefinite is Indefinite FDA, required if the question must be January Indefinite answer to answered if the 14,2016 (Y/N) F37, Subjects answer to Release, Update ‘Human Form USU F38, is Human Subjects to Existing Rule Involved’ FI2, "Yes" on the Involved is (added ‘Yes’ Other Project on the Other F99/K00) Information. Project Information. PHS Human 024.7.2 N N Incl : Incl: If Human The Human E New rule NIH, F05, Subject Involved Subjects Subjects 4.0 F30, is on the Involvement ‘No’ and F31, Other Project Indefinite FDA, Information and question cannot January Indefinite Human Subjects be marked the 14,2016 ‘if (Y/N) F37, Involvement answer to Release, Update Form USU F38, Indefinite is Human Subjects to Existing Rule FI2, provide Involved is (added ‘Yes’, ‘No’ error on the Other F99/K00) Project Information. PHS Human 024.8.1 N N Incl : Incl: If Human The Human E New rule NIH, F05, Subjects Subjects Clinical Subjects 4.0 F30, Phase Trial question and F31, III Clinical Trial is must be if “Yes” Clinical FDA, Yes, Clinical the answer to January Trial (Y/N) Trial must be Human Subjects 14,2016 F37, Yes. NIH-Defined Release, Update Form USU F38, Phase III Clinical to Existing Rule FI2, Trial is “Yes. (added F99/K00)
PHS Form Human Subjects Indefinite (Y/N) 024.7.1 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, An answer to Human Subjects Involvement Indefinite is required if the answer to ‘Human Subjects Involved’ is "Yes" on the Other Project Information. The Human Subjects Involvement Indefinite question must be answered if the answer to Human Subjects Involved is ‘Yes’ on the Other Project Information. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Human Subjects Indefinite (Y/N) 024.7.2 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, If Human Subject Involved is ‘No’ on the Other Project Information and Human Subjects Involvement Indefinite is ‘Yes’, provide error The Human Subjects Involvement Indefinite question cannot be marked ‘if the answer to Human Subjects Involved is ‘No’ on the Other Project Information. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Human Subjects Clinical Trial (Y/N) 024.8.1 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, If Human Subjects Phase III Clinical Trial is Yes, Clinical Trial must be Yes. The Human Subjects Clinical Trial question must be “Yes” if the answer to Human Subjects NIH-Defined Phase III Clinical Trial is “Yes. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00)
eSub-validations-draft-08-21-2017.docx