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How
do I track recruitment of research participants?
It is your responsibility to regularly monitor recruitment
in your research project, including composition of participants. Your
yearly progress report must include an Inclusion
Enrollment Report Form which shows the cumulative accrual
of your participants. In addition, NHLBI has developed
a policy to establish milestones in studies. Terms
and Conditions for Accrual of Research Subjects in Research describes
the partnership between you and the NHLBI to ensure adequate
enrollment and timely project completion.
Regardless of the mechanism of support, NHLBI staff will
closely monitor progress during your award. Monitoring may
include regular communications with you and your research
staff. The Terms and Conditions of Award for a clinical
trial will include recruitment milestones expected to be
met by centers at specific time periods, accrual goals for
women, children, and minorities (as appropriate), any requirements
regarding minimum effort of specific investigators, and any
other identified requirements for completion of the approved
research. As with any award, continuation, even during the
period recommended for support, is conditional upon satisfactory
progress. If, at any time, recruitment falls significantly
below the projected milestones for recruitment, NHLBI may
consider ending support and negotiating a phase-out of the
award.
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