The mission of the NINDS Division of Clinical Research is to provide oversight for clinical trials to test the safety and efficacy of innovative treatments of neurological disorders and stroke, epidemiological studies of natural history, biomarker studies, and studies designed to elucidate the causes of neurological disorders. DCR also develops new clinical science initiatives, ensures the proper level of patient safety monitoring, maintains the scientific integrity of clinical trials, and provides expertise in statistics and clinical trial design to the Institute and to clinical investigators.
Investigators are encouraged to contact the program director who is responsible for the disease of interest. View a list of NINDS program directors by category.
View information related to translational research.
Policy for Submitting Applications Proposing Clinical Trials
- Notice of NINDS Policy for Submission of Applications and Participation in PA-18-345 "NIH Research Project Grant (Parent R01) - Clinical Trial Required". NINDS Only accepts Clinical Trial Applications Proposing Mechanistic Studies for Clinical Trial Parent R01 [NOT-NS-18-011]
- Notice of NINDS Policy for Submission of Applications Containing Clinical Trials [NOT-NS-18-054]
NINDS Office of Global Health and Health Disparities
Within the Division of Clinical Research, the office of Global Health and Health Disparities (OGHHD) leads the coordination and development of programs and initiatives that foster global research and research on health disparities in neurological disorders and stroke.
Contact: Richard T. Benson, M.D., Ph.D.
Early Phase Pain Investigation Clinical Network (EPPIC-Net)
Early phase clinical trials of highly meritorious, non-addictive pain therapies in well-characterized patient cohorts with pain conditions of high unmet need.
Contact: Barbara I. Karp, M.D.
SIREN (Strategies to Innovate EmeRgENcy Care Clinical Trials Network)
Clinical trials in neurologic, heart, lung, blood, and traumatic emergencies.
Resources and Tools
Clinical Trial Definition
Clinical Trial FORMS-E (use on or before May 24, 2020)
Clinical Trial FORMS-F (use on or after May 25, 2020)
Certificates of Confidentiality
Single IRB Policy
Guidelines for monitoring data and safety from ongoing clinical trials. Responsibilities, membership, and reporting are included.
Information for NINDS-awardees in the use of CDEs in clinical trials and exploratory trials.
Instructions for NINDS awardees on how to submit study results and for the general public on how to request datasets.
NIH data sharing regulations, policy and implementation guidance.
This document provides the NINDS guidelines for incremental funding of large multicenter studies and should be used as a reference for program and grants management staff to discuss the funding of large multicenter studies.
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure.
A realistic, targeted strategic recruitment and retention plan, adequately resourced, implemented and adjusted as needed, will have a significant impact on recruitment and retention, ensuring that your clinical trial can complete on time and have the intended impact.