AND Questionnaire, or Add Clinical or Trial’, add a delayed onset New Other to study and check the Requested Clinical ‘Anticipated Information is box. Or, you Trial’ Onset not provided on 1.4a must provide an Study a component for Other Requested a Clinical Trial Information 1.4d attachment. FOA when is human subject ALL is “YES” “Yes) selected on the Other Project Information form within the component PHS Add 034.4.6 N N NIH, 1.0 Both Provide Error if The E New ‘Anticipated Clinical box Rule Trial’ Human New response to cannot be checked October Subject Delayed “Anticipated for Delayed Onset 2017 and Onset Clinical is Trial” = N Study titled <study Release Clinical Study checked for at title> since this Trial least one Funding Opportunity delayed onset Announcement does study when the not allow clinical trials. Clinical FOA does not Trial support Clinical Tria. PHS Add 034.4.7 N N NIH, 1.0 Both Provide error if A Justification E New attachment is Rule Human New Delayed Onset required for Delayed October Subject Delayed Study is present, Onset Study titled 2017 and but Justification <study title>. Release Clinical
Add New Onset Study AND to 1.4a 1.4d is ALL “Yes) Clinical Trial’, or Other Requested Information is not provided on a component for a Clinical Trial FOA when human subject “YES” is selected on the Other Project Information form within the component Questionnaire, or add a delayed onset study and check the ‘Anticipated Clinical Trial’ box. Or, you must provide an Other Requested Information attachment. PHS Human Subject and Clinical Trial Add New Delayed Onset Study Clinical Trial 034.4.6 N N NIH, 1.0 = N Both Provide Error if response to “Anticipated Clinical Trial” is checked for at least one delayed onset study when the FOA does not support Clinical Tria. The ‘Anticipated Clinical Trial’ box cannot be checked for Delayed Onset Study titled <study title> since this Funding Opportunity Announcement does not allow clinical trials. E New Rule October 2017 Release PHS Human Subject and Clinical Add New Delayed 034.4.7 N N NIH, 1.0 Both Provide error if Delayed Onset Study is present, but Justification A Justification attachment is required for Delayed Onset Study titled <study title>. E New Rule October 2017 Release