N NIH, 1.0 Both Y E New Rule Human Subject N Provide error if same Study AHRQ October and Clinical Study Record or Record and 2017 Trial Delayed Onset Study Delayed Release Information title is duplicated in an Onset study application. titles must Section 1 be unique – Basic Note: Study Record and cannot Information and Delayed Onset be Study Record cannot duplicated in 1.1 Study Title have the same titles an i.e. all study titles must application. be unique within an application Attachment 000.8 Y Incl: Both Both All must The E N validation be in PDF format <attachment A, attachment AHRQ, is not in VA, PDF format. USU, All attachments must be provided to the agency in PDF format with a .pdf extension. Attachment 000.9 N N Incl : Both Both If an attachment is The {0} E validation NIH, empty (0 bytes), the attachment CDC, following error should was empty. FDA, be returned PDF AHRQ, attachments VA, cannot be USU, empty, password protected or
Human Subject and Clinical Trial Information Section 1 – Basic Information 1.1 Study Title N N NIH, AHRQ 1.0 Both Y Provide error if same Study Record or Delayed Onset Study title is duplicated in an application. Note: Study Record and Delayed Onset Study Record cannot have the same titles i.e. all study titles must be unique within an application Study Record and Delayed Onset study titles must be unique and cannot be duplicated in an application. E New Rule October 2017 Release Attachment validation 000.8 Y N Incl: AHRQ, VA, USU, Both Both All must be in PDF format The attachment is not in PDF format. All attachments must be provided to the agency in PDF format with a .pdf extension. E Attachment validation 000.9 N N Incl : NIH, CDC, FDA, AHRQ, VA, USU, Both Both If an attachment is empty (0 bytes), the following error should be returned The {0} attachment was empty. PDF attachments cannot be empty, password protected or E <attachment A,
eSub-validations-draft-08-21-2017.docx