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Plans If yes, describe the single IRB plan 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” required for study titled <Study Title> PHS Human Subject and Clinical Trial Section 3 – and Plans 3.3 Data and Safety Plan 034.7.5 N N NIH, 1.0 = “R" or "O" or "I") AND to 1.4a 1.4d is ALL 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 in the Clinical Trial Questionnaire. E New Rule October 2017 Release
eSub-validations-draft-07-12-2018.docx