CDC, 4.0 Other Project attachment is Plan FDA, and Information form required if the within the same response to the of component Human Subjects Human USU question on the Other Subjects Project Information is ‘Yes’. PHS N N Incl : Required if is The Data Safety New Rule “yes” E Plan NIH, selected as the Monitoring Plan for Forms 2.0, answer to the attachment is D, as part Plan 4.0 required if the of March “Clinical Trial?” Data USU and question on the response to the 2016 Safety PHS Cover Page Clinical Trial question Release Supplemental Form on the cover Page Plan Supplement is “Yes”. PHS N N Incl : Required if Human The Inclusion of E Plan NIH, Subjects is yes and Women and CDC, 4.0 Exemption is not E4 Minorities attachment Plan FDA, and on Other Project is required if the Inclusion Information form response to the of within the same Human Subjects Women USU component question on the Other and Project Information is and the ‘Yes’ Exemption Number is not 4. PHS N N Incl : Required if Human The Inclusion of E Plan NIH, Subjects is yes and Children attachment CDC, 4.0 Exemption is not E4 is required if the Plan FDA, and on Other Project response to the Inclusion Information form Human Subjects of within the same question on the Other Children USU component Project Information is and the ‘Yes’ Exemption Number is not 4.
Plan of Human Subjects CDC, FDA, USU 4.0 and Other Project Information form within the same component attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’. PHS Plan Plan Data Safety 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 New Rule for Forms D, as part of March 2016 Release PHS Plan Plan Inclusion of Women and N N Incl : NIH, CDC, FDA, USU 4.0 and Required if Human Subjects is yes and Exemption is not E4 on Other Project Information form within the same component The Inclusion of Women and Minorities attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’ and the Exemption Number is not 4. E PHS Plan Plan Inclusion of Children N N Incl : NIH, CDC, FDA, USU 4.0 and Required if Human Subjects is yes and Exemption is not E4 on Other Project Information form within the same component The Inclusion of Children attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’ and the Exemption Number is not 4. E
eSub-validations-draft-09-12-2017.docx