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Clinical Trials Unit (CTU)


The Clinical Trials Unit is a group of clinical research experts who collaborate to provide NINDS intramural investigators with support in developing and executing clinical research studies, as well as regulatory guidance.  CTU members have extensive experience and knowledge regarding clinical research regulations, IRB and scientific review procedures, protocol navigation, protocol development, regulatory support, study auditing and monitoring, as well as statistical plan development and analysis. As part of the Office of the Clinical Director, the Clinical Trials Unit is responsible for quality assurance of clinical research studies as well as DSMB oversight.

           
Who We Are
Dietrich Haubenberger, M.D., CTU Director
Dana Evans, BS, Protocol Navigator 
Rose Hayden, R.N., Regulatory Nurse Specialist 
Eunhee Kim, Ph.D., Statistician
Sandra Martin, M.S., Quality Assurance 
Samantha McGrath, Clinical Research Associate
Sherri Gollins, PTMS liaison
Melonise Battle,
Data Manager
Tianxia Wu, Ph.D., Statistician
Gina Norato, M.S.,
Statistician
Wanda Haddaway, Office Manager and Credentialing Specialist

CTU Offices:

Office of Biostatistics:  The Office of Biostatistics (OB) is an office within the Clinical Trials Unit (CTU), Office of the Clinical Director (OCD) at the NINDS.  The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.  The OB 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.  For additional information, contact the Office of Biostatistics at biostatistics@ninds.nih.gov

Quality Assurance Office:  The Quality Assurance Office is an office in the NINDS Clinical Trials Unit within the Office of the Clinical Director.  The QA Office assists the Clinical Neuroscience Program by disseminating NIH and FDA policy and guidelines and by providing assistance to the research staff to ensure compliance with good clinical practice guidelines.  The QA office provides oversight of protocol compliance by performing random and for-cause QA audits and QA monitoring of applicable active protocols. For additional information, contact Sandra Martin at 301-496-1116 or martins@ninds.nih.gov.

Mission:

The mission of the Clinical Trials Unit (CTU) is to create an environment for state-of-the-art clinical trials to promote successful integration into the translational development of treatments of neurological disease.


Aims and Goals:

As a core unit under the NINDS Office of the Clinical Director, the CTU aims to support and facilitate clinical research at the NINDS intramural research program by providing assistance and resources to investigators throughout the life cycle of a protocol; from protocol development, start-up, and execution to data analysis and reporting.

It is the goal of the NINDS CTU to ensure quality science and the protection of human subjects participating in research in the NINDS intramural research program.  In an effort to advance these goals, the NINDS CTU provides oversight of clinical research conducted by NINDS intramural investigators and provides education and training opportunities to all members of the clinical research study team.

The NINDS CTU is dedicated to promote the advancement of clinical trial methodology through research collaborations with clinical investigators at NINDS as well as outside partners.