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Clinical Trials Unit (CTU)


As part of the Office of the Clinical Director, the Clinical Trials Unit (CTU) 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, safety oversight, regulatory support, protocol auditing and monitoring, as well as statistical plan development and analysis.

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 promoting the advancement of clinical trial methodology through research collaborations with clinical investigators at NINDS as well as outside partners.

Who We Are
Vacant: CTU Director
Dana Evans, BS, Protocol Navigator 
Rose Hayden, R.N., Regulatory Nurse Specialist 
Sandra Martin, M.S., Quality Assurance 
Rose Cuento, CRNP, Research Coordinator
Sherri Gollins, PTMS liaison
Melonise Battle,
Data Manager
Brian Trummer, MD, PhD, Clinical Trials Methodology Fellow

Tianxia Wu, Ph.D., Statistician
Gina Norato, M.S.,
Statistician
Xuemin Zhang, PhD,
Statistician
Bradley Alvarez, Office Manager and Credentialing Specialist





CTU Offices:


Office of Biostatistics
Lead: Tianxia Wu, PhD

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.



Office of Quality Assurance and Data Management
Lead: Sandra Martin, MS

The Quality Assurance and Data Management Office (QADMO) is located  in the NINDS Clinical Trials Unit within the Office of the Clinical Director. The QADMO assists the Clinical Neuroscience Program by disseminating NIH and FDA policy and guidelines and by providing assistance to clinical research teams to ensure compliance with good clinical practice guidelines. 

The Quality Assurance section provides oversight of protocols to ensure compliance with the protocol and applicable policy, by performing random and for-cause quality assurance audits of intramural research protocols and on-going monitoring of FDA-regulated protocols.

The Data Management section assists study teams with the development of protocol specific data management plans and database systems for the accurate collection, recording and storage of study related data.

Research Staffing Support Office
Lead: Rosalind Hayden, RN

The Research Staffing Support Office is an office in the NINDS Clinical Trials Unit within the Office of the Clinical Director.  The RSSO assists the Clinical Neuroscience Program by supporting the PIs and research support staff in 3 key areas.

  • The RSSO Protocol Navigation Team provides navigation and protocol writing services for assigned groups.
  • The RSSO Patient Care Coordinator provides patient care coordination services for assigned groups.
  • The RSSO assists with standardization of the hiring, training, and mentoring process for NINDS research support staff, including Protocol Navigators, Research Coordinators (RN and non-RN), and Patient Care Coordinators.

Research Training and Education Office
Lead: Sandra Bonifant, MS, CIP

The Research Training and Education (RTE) Office is housed within the Clinical Trials Unit (CTU) of the NINDS Office of the Clinical Director. The RTE office will centralize core regulatory and educational training for investigators and staff, provide oversight of clinical research activities, and be responsible for liaising with multiple departments and agencies, both within and outside of NIH. The RTE office provides a single point of contact for identifying and clarifying diverse mandates and complex policies necessary to conduct clinical trials at NIH and is tasked with identifying, evaluating and ensuring compliance with various training requirements of NINDS employees and volunteers in order to carry out NINDS mission.

Safety Oversight and Regulatory Compliance Office
Lead: Lauren Reoma, MD

The Safety Oversight and Regulatory Compliance Office (SORC) is responsible for overseeing all processes involved in centrally supporting NINDS sponsored Investigational New Drug (IND) and Investigational Device Exemption (IDE) clinical trials that are regulated by the U.S. Food and Drug Administration (FDA), including coordination across the Clinical Trial Unit (CTU)  for goal-directed research implementation.

Office of Administrative Support
Lead:
Bradley Alvarez, BA

The Office of Administrative Support provides administrative support to the NINDS Scientific Review Committee as well as the NINDS Clinical Trials Unit.

  • Support of NINDS Scientific Review Committee

Following Standards for Clinical Research within the NIH Intramural Research Program, as established by the NIH Clinical Center Medical Executive Committee, all protocols involving human subjects must undergo review of scientific content by an Institute’s scientific review committee. For NINDS, this function is carried out by the Scientific Review Committee (SRC). The role of the SRC is to review each NINDS research study for scientific merit and contribution to the research mission of NINDS and at time of initial submission. SRC is furthermore tasked to review the impact on central resources for each study. The Office of Administrative Support provides operational and administrative support, including logistics, meeting preparation, and summary minutes for the SRC, as well as coordinates with other entities at NIH (e.g., Chief Scientific Officer of the Clinical Center, NIH IM IRB, etc.) to ensure all requirements for protocols at NINDS are met in order to proceed to IRB review and subsequent study implementation. The Office of Administrative Support provides process audits of the new central IRB Integrated Research Information System (iRIS) to ensure that all necessary study actions are first routed to SRC before IRB review.

  • Support of NINDS Clinical Trials Unit

The Administrative Support Office provides assistance to all CTU offices by coordinating the budget and supply ordering, IT equipment tracking, coordination of all aspects of travel, meeting coordination and scheduling, centralizing and cataloguing the contracts that CTU uses for protocol support services, as well as providing tracking and auditing of CTU resources and support needs as an entire unit.