N N NIH, 1.0 Excl: Both Maximum is E New PHS Section 034.6.4 Provide error for D43, required for study Rule Human 2 a Human – K12 titled <Study Title> October Subject Study Subject and 2017 and Clinical Trial is Release Clinical StudyRecord if not = Trial Maximum Age “I” limit is not provided and the 2.3 Age selection is not Limits NA and the study is exempt Age from federal regulations (1.2 is yes) and E4 is not the only exemption number selected PHS Section 034.6.12 N N NIH, 1.0 Excl Both Provide error if A number for E New D43, Maximum Age Rule Human 2 N/A (No limits) – K12 cannot be provided October Subject Study has been on study titled <study 2017 and selected as is title> since N/A (No Release Clinical Maximum Age not = limit) has been Trial unit and a selected as the unit “I” number for of time. Maximum is 2.3 Age provided and the Limits study is exempt from federal – regulations (1.2 is yes) and E4 is N/A (No not the only limits) exemption
PHS Human Subject and Clinical Trial Section 2 – Study 2.3 Age Limits Age 034.6.4 N N NIH, 1.0 is not = “I” Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial StudyRecord if Maximum Age limit is not provided and the selection is not NA and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected Maximum is required for study titled <Study Title> E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 2 – Study 2.3 Age Limits – N/A (No limits) 034.6.12 N N NIH, 1.0 is not = “I” Excl D43, K12 Both Provide error if N/A (No limits) has been selected as Maximum Age unit and a number for Maximum is provided and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption A number for Maximum Age cannot be provided on study titled <study title> since N/A (No limit) has been selected as the unit of time. E New Rule October 2017 Release
eSub-validations-draft-09-12-2017.docx