number selected. N N NIH, 1.0 Excl Both E New PHS Section 034.6.11 Provide error if A number for D43, Rule Human 2 N/A (No limits) Minimum Age cannot – K12 October Subject Study has been be provided on Study 2017 and selected as titled <study title> is Release Clinical Minimum Age since N/A (No limit) not = Trial unit and a has been selected as “I” number for the unit of a time. Minimum Age is Age provided and the Limits study is exempt from federal Age – regulations (1.2 is yes) and E4 is N/A (No not the only limits) exemption number selected. PHS Section 034.6.4 N N NIH, 1.0 Excl: Both Provide error for Maximum is E New 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
number selected. PHS Human Subject and Clinical Trial Section 2 – Study Age Limits Age – N/A (No limits) 034.6.11 N N NIH, 1.0 is not = “I” Excl D43, K12 Both Provide error if N/A (No limits) has been selected as Minimum Age unit and a number for Minimum Age is provided and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected. A number for Minimum Age cannot be provided on Study titled <study title> since N/A (No limit) has been selected as the unit of a time. E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 2 – Study 2.3 Age Limits 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 Maximum is required for study titled <Study Title> E New Rule October 2017 Release
eSub-validations-draft-07-12-2018.docx