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When can I begin enrolling participants?

You can begin to enroll patients when all of the following issues have been resolved:

  • Have all human subjects concerns been addressed and answered?
  • For those studies with a DSMB , have approvals been obtained?
  • Has NHLBI approved your protocol, Informed Consent forms, monitoring plan and recruitment milestones?
  • Has NHLBI received documentation of all IRB approvals of your protocol, consent forms and data monitoring plan?
  • Has the IND or IDE information (number, name and institution of the holder, written comments from FDA and date that you filed) been forwarded to NHLBI?
  • Have all human subject training documents been received by NHLBI?
  • Has Fogarty clearance been obtained for work in a foreign institution?
  • Has your institution filed a Federalwide Assurance with OHRP ?
  • Have you registered your study to comply with ICMJE requirements?

Page Last Updated: February 2011
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