NINDS Policy for Submission of Applications Containing Clinical Trials


Important Points: Beginning with NINDS applications submitted for the
June 5, 2012 submission date, NINDS will not accept unsolicited R01
applications which include clinical trials of potential therapies under
the NIH parent R01 Funding Opportunity Announcement (FOA) PA-11-260 and
subsequent revisions to this FOA. For this purpose, a clinical trial is
defined as a prospective biomedical or behavioral research study of
human subjects that is designed to answer specific questions about
pharmacologic, behavioral, biologic, surgical, or device interventions.

Applicants submitting unsolicited clinical trial applications must
submit to one of the following:

* NINDS Exploratory Clinical Trials (R01) PAR-10-199
* NINDS PHASE III Investigator-Initiated Multi-Site Clinical
Trials (U01) PAR-11-173

Clinical trial applications also may be submitted to NINDS in response
to other NINDS-specific announcements.

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