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
- Has Fogarty clearance been obtained for work in a foreign
- Has your institution filed a Federalwide
Assurance with OHRP ?
- Have you registered your study to comply with ICMJE requirements?
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov