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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, 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?
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