NCATS supports a broad range of clinical research tools that facilitate clinical trial design, patient recruitment and regulatory compliance.
For example, through the Clinical and Translational Science Awards (CTSA) Program, many of these tools are developed, perfected and shared broadly throughout the CTSA Program network. Designed to be shared, these resources can further enable and accelerate research collaboration, particularly for multisite studies. Selected clinical research tools are listed below.
NCATS also provided supplemental grant funding to support a CTSA Program network project entitled, “Enhancing Clinical Research Professionals’ Training and Qualifications” (3UL1TR000433-08S1). View the results of this work (PDF - 139KB).
Following are NCATS and other selected clinical research tools:
Accelerated Clinical Trial Agreement, developed through a CTSA Program initiative, is a standardized contract model designed to reduce negotiation time and contracting delays for industry-sponsored multisite clinical studies, including Phase IIb and Phase III trials.
BEST (Biomarkers, EndpointS, and other Tools) Resource is an online glossary developed by a Food and Drug Administration and NIH joint committee to clarify terms used in translational science and medical product development, with a focus on study endpoints and biomarkers.
ClinRegs is a public website developed by NIH’s National Institute of Allergy and Infectious Diseases to help researchers navigate country-specific regulatory information as they plan and implement clinical trials.
Good Clinical Practice (GCP) Social and Behavioral Research E-Learning Course was developed with CTSA Program support to provide researchers with training that applies GCP principles to social and behavioral research. GCP is an international ethical and scientific quality standard that helps assure the safety, integrity, and quality of clinical trials.
NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance Platform, including an authorization agreement and joinder, the first of which is an umbrella agreement that establishes a harmonized approach for roles and responsibilities of the single institutional review board (IRB) and participating sites. The joinder enables institutions to sign on to or join the authorization agreement.
The NCATS Toolkit for Patient-Focused Therapy Development is a centralized collection of online resources that can help patient groups advance through the research and development process for new treatments.
PhenX Toolkit offers well-established, broadly validated measures of phenotypic traits and environmental exposures of interest to investigators in human genomics, epidemiology and biomedical research.
REDCap is an easy-to-use, freely available tool for clinical study management and data capture, providing investigators with the ability to build and manage online surveys and databases.
ResearchMatch provides a way to connect people who are trying to find research studies with researchers who are seeking people to participate in their studies.