N N NIH, 1.0 Excl: Both You must answer E New PHS Section 034.5.5 Provide error if D43, Yes to all questions Rule Human 1 responses to – K12 1.4.a through 1.4.d in October Subject Basic questions 1.4.a the Clinical Trial 2017 and through 1.4.d Questionnaire in at Release Clinical are NOT all = least one study “R" Trial on a FOA “Yes” record 1.4 that requires Clinical Clinical Trials on Trial at least one study record in the applicaiton 1.4.a – 1.4.d PHS Section 034.6.1 N N NIH, 1.0 Excl: Both Provide error for Conditions or Focus E New D43, of Study is required Rule Human 2 a Human – K12 for Study titled October Subject Study Subject and <Study Title>. 2017 and Clinical Trial Release Clinical Study Record if Trial Condition or Focus of Study is not provided and the study is exempt from or federal Focus of regulations (1.2 Study is yes) and E4 is not the only exemption number selected
PHS Human Subject and Clinical Trial Section 1 – Basic 1.4 Clinical Trial 1.4.a – 1.4.d 034.5.5 N N NIH, 1.0 = “R" Excl: D43, K12 Both Provide error if responses to questions 1.4.a through 1.4.d are NOT all “Yes” on a FOA that requires Clinical Trials on at least one study record in the applicaiton You must answer Yes to all questions 1.4.a through 1.4.d in the Clinical Trial Questionnaire in at least one study record E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 2 – Study or Focus of Study 034.6.1 N N NIH, 1.0 Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial Study Record if Condition or Focus of Study is not provided and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected Conditions or Focus of Study is required for Study titled <Study Title>. E New Rule October 2017 Release
eSub-validations-draft-08-21-2017.docx