Supp. Progress Form Report Publication List 024.5 PHS Human Subjects Involved? (Y/N) Supp. Form PHS Human 024.7.1 N N Incl : Incl: Incl: An answer to Human The Human E New rule NIH, V2.0 F05, F30, Subjects Involvement Subjects Subjects CDC, F31, Indefinite is required if Involvement Involvement FDA, F32,F33, the answer to Indefinite question ‘Human Supp. Indefinite (Y/N) AHRQ F37, F38, Subjects is must be answered January 14,2016 Involved’ Form FI2, "Yes" on the Other if the answer to Release, Update to F99/K00 Project Information. Human Subjects Existing Rule (added Involved is on F99/K00) ‘Yes’ the Other Project Information. PHS Human 024.7.2 N N Incl : Incl: Incl: If Human Subject The Human E New rule NIH, V2.0 F05, F30, Involved is on the Subjects Subjects ‘No’ CDC, F31, Other Project Involvement Involvement FDA, F32,F33, Information and Human Indefinite question Supp. Indefinite (Y/N) AHRQ F37, F38, Subjects Involvement cannot be marked January 14,2016 Form FI2, Indefinite is the answer to Release, Update to ‘Yes’, ‘if F99/K00 provide error Human Subjects Existing Rule (added Involved is on F99/K00) ‘No’ the Other Project Information. PHS Human 024.8.1 N N Incl : Incl: Incl: If Human Subjects The Human E New rule NIH, V2.0 F05, F30, NIH-Defined Phase III Subjects Clinical Subjects CDC, F31, Clinical Trial is Yes, Trial question must FDA, F32,F33, Clinical Trial must be be if the “Yes” Clinical Trial Supp. AHRQ F37, F38, Yes. answer to Human January 14,2016 (Y/N) Form FI2, Subjects Release, Update to F99/K00 Phase III Existing Rule (added Clinical Trial is F99/K00) “Yes.
Supp. Form Progress Report Publication List PHS Supp. Form Human Subjects Involved? (Y/N) 024.5 PHS Supp. Form Human Subjects Involvement Indefinite (Y/N) 024.7.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 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 Supp. Form Human Subjects Involvement Indefinite (Y/N) 024.7.2 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 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 Supp. Form Human Subjects Clinical Trial (Y/N) 024.8.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 If Human Subjects NIH-Defined 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 Phase III Clinical Trial is “Yes. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00)