NINDS Policy for Submission of Applications Containing Clinical Trials

Notice Number: NOT-NS-13-006

Update: The following update relating to this announcement has been issued:

• July 20, 2016 - This Notice has been replaced with NINDS Policy for Submission of Applications Containing Clinical Trials. See Notice NOT-NS-16-034.
• July 22, 2013 - See Issuance of PAR-13-278, NINDS Phase III Investigator-Initiated Efficacy Clinical Trials (U01).

Release Date: February 6, 2013

This Notice replaces NOT-NS-12-007

PA-11-260
PAR-10-199
PAR-11-173

National Institute of Neurological Disorders and Stroke (NINDS)

The purpose of this Notice is to define the types of clinical studies which may be submitted to NINDS in response to the NIH parent R01 Funding Opportunity Announcement (FOA) PA-11-260 and subsequent revisions to this FOA. NINDS will not accept investigator initiated R01 applications which include clinical trials under PA-11-260. A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about the safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions.

This policy applies only to clinical trials submitted to PA-11-260 for investigator initiated R01 applications and subsequent revisions. This policy does not apply to (1) other NINDS-specific announcements that specifically solicit clinical trials, (2) exploratory IND studies as defined by the FDA (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078933.pdf) or (3) early feasibility studies of devices as defined by the FDA (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.pdf).

Applicants submitting investigator initiated applications to NINDS which contain a clinical trial must submit to one of the following NINDS FOAs specifically designed for clinical trials:

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

Please direct all inquiries to:

Crina Frincu, PhD
Office of Clinical Research
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2210
6001 Executive Boulevard
Bethesda, MD 20892
Telephone: (301) 496-9135
Fax: (301) 410-1080
Email: CRLiaison@ninds.nih.gov