PHS Research Plan 024.4 Attachments: Progress Supp. Report Form Publication List PHS Human 024.5 Subjects Involved? (Y/N) Supp. Form PHS Human 024.7.1 N N Incl : Incl: Incl: An answer to Human The Human E January 14,2016 NIH, V2.0 F05, Subjects Involvement Subjects Release, Update to Subjects CDC, F30, Indefinite is required if Involvement Existing Rule (added Involvement FDA, F31, the answer to Indefinite question F99/K00) ‘Human Supp. Indefinite (Y/N) AHRQ F32,F33, Subjects is must be answered Involved’ Form F37, "Yes" on the Other if the answer to F38, FI2, Project Information. Human Subjects F99/K00 Involved is on ‘Yes’ the Other Project Information. 024.7.2 N N Incl : Incl: Incl: If Human Subject The Human E January 14,2016 PHS Human NIH, V2.0 F05, Involved is on the Subjects Release, Update to Subjects ‘No’ CDC, F30, Other Project Involvement Existing Rule (added Involvement FDA, F31, Information and Indefinite question F99/K00) Supp. Indefinite (Y/N) AHRQ F32,F33, Human Subjects cannot be marked Form F37, Involvement Indefinite the answer to ‘if F38, FI2, is provide error Human Subjects ‘Yes’, F99/K00 Involved is on ‘No’ the Other Project Information. PHS Human 024.8.1 N N Incl : Incl: Incl: If Human Subjects The Human E January 14,2016 NIH, V2.0 F05, NIH-Defined Phase III Subjects Clinical Subjects Release, Update to CDC, F30, Clinical Trial is Yes, Trial question must Existing Rule (added FDA, F31, Clinical Trial must be be if the “Yes” Clinical Trial Supp. F99/K00) AHRQ F32,F33, Yes. answer to Human (Y/N) Form F37, Subjects Phase III
PHS Supp. Form Research Plan Attachments: Progress Report Publication List 024.4 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 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 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, 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 E January 14,2016 Release, Update to Existing Rule (added F99/K00)
eSub-validations-draft-9-14-2016.docx