K76, K43 site? N N NIH, 1.0 Excl: Both E New PHS Section 034.7.4 Provide error if a Since you answered D43, Rule Human 3 response to the Yes to the question – K12 October Subject question yes, regarding multi-site “If 2017 and and describe the studies, a single IRB Release Clinical single IRB plan attachment is plan” Trial is not provided required for study Plans when the titled <Study Title> answer to the If question this “Is yes, a multi-site describe study that will the use the same single protocol to IRB plan conduct human subjects research at more than one domestic site?” is “Yes” N N NIH, 1.0 Both E New PHS Section 034.7.5 Provide error for For Study titled < Rule Human 3 a Clinical Trial Study Title>, a Data – K12 October Subject Study if Data and Safety 2017 and and and Safety Monitoring Plan Release Clinical Monitoring Plan attachment is = “R" Trial is not provided required since you or Plans answered Yes to "O" or "I") questions 1.4.a-1.4.d AND
site? K76, K43 PHS Human Subject and Clinical Trial Section 3 – and Plans If yes, describe the single IRB plan 034.7.4 N N NIH, 1.0 Excl: D43, K12 Both Provide error if a response to the question “If yes, describe the single IRB plan” is not provided when the answer to the question “Is this a multi-site study that will use the same protocol to conduct human subjects research at more than one domestic site?” is “Yes” Since you answered Yes to the question regarding multi-site studies, a single IRB plan attachment is required for study titled <Study Title> E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 3 – and Plans 034.7.5 N N NIH, 1.0 = “R" or "O" or "I") AND K12 Both Provide error for a Clinical Trial Study if Data and Safety Monitoring Plan is not provided For Study titled < Study Title>, a Data and Safety Monitoring Plan attachment is required since you answered Yes to questions 1.4.a-1.4.d E New Rule October 2017 Release
eSub-validations-draft-08-21-2017.docx