Clinical Trials Unit

Clinical Trials Unit main banner

Background

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 knowledge regarding clinical research regulations, IRB and scientific review procedures, protocol development, protocol navigation, protocol development, safety oversight, data management, 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.


Offices

Biostatistics Office; Gina Norato, MS

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. For additional information, contact the Biostatistics Office at biostatistics@ninds.nih.gov.

Quality Assurance and Data Management Office; Sandra Martin, MS

The Quality Assurance and Data Management Office 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 routine 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 electronic data capture systems for the accurate collection, recording and storage of study related data.

Research Staffing Support Office; Rosalind Hayden, RN

The Research Staffing Support Office assists the Clinical Neuroscience Program by supporting the PIs and research support staff in three key areas.

  • The Protocol Navigation core provides navigation and protocol writing services for assigned groups.
  • The Patient Care Coordinator core provides patient care coordination services for assigned groups.
  • The Research Coordination core provides training, mentoring, and oversight for Research Coordinators assigned to study teams within the intramural program.  

Research Training and Education Office; Sandra Bonifant, MS, CIP

The Research Training and Education Office offers centralized research training for investigators and staff.  The 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 and clinical research in the intramural research program.

Regulatory and Medical Affairs Office; Dana Evans, BA

The Regulatory and Medical Affairs Office 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.

Clinical Trials Administrative Support Office; Bradley Alvarez, BA

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

  • Support of the 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.