Clinical Research Support

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The NINDS Clinical Trials Unit (CTU) is comprised of a group of clinical research experts who collaborate to provide NINDS intramural investigators with support in developing and executing clinical research studies.  CTU members have extensive experience and knowledge regarding clinical research regulations, IRB and scientific review procedures, protocol development, protocol navigation, safety oversight, data management, regulatory support, protocol auditing and monitoring, as well as statistical plan development and analysis.

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Biostatistics Support
The Biostatistics Office contributes to the NINDS mission by providing objective, high-quality statistical solutions through proper implementation of statistical methods and by promoting the use of rigorous quantitative methods.
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Data Management Support
Clinical Research Data Management is critically important to ensure the generation of high quality, reliable, and statistically sound data.
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Data and Safety Monitoring Support
Data and Safety Monitoring is integral to good clinical research, by ensuring the safety of research participants and the integrity of research data consistent with NIH and FDA requirements.
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Protocol Oversight Support
The monitoring and auditing of clinical research helps to ensure compliance with the protocol, NIH regulations, and Good Clinical Practice (GCP) guidelines.
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Regulatory Support
The Regulatory and Medical Affairs Office (RMA) supports research teams throughout the life cycle of their investigational drug and/or device clinical trial through preparation, submission, and maintenance of regulatory applications to the FDA.
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Research Staffing Support
Conducting clinical research requires the support of a team of individuals with specialized experience.