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Clinical Research Toolbox

We support a broad range of clinical research tools that facilitate clinical trial design, patient recruitment and regulatory compliance.

About the Clinical Research Toolbox

We support the development of many clinical research tools designed to be shared broadly. These resources can further enable and speed research collaboration, particularly for multisite trials. View a selection of clinical research tools.

Accelerated Clinical Trial Agreement

Created through a Clinical and Translational Science Awards (CTSA) Program initiative, this standardized contract model is designed to reduce negotiation time and contracting delays for industry-sponsored multisite clinical studies, including Phase IIb and Phase III.

BEST (Biomarkers, EndpointS, and other Tools) Resource

This online glossary was created by a U.S. 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

This public website was created 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

This course created 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

This includes 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.

NCATS Toolkit for Patient-Focused Therapy Development

Toolkit is a centralized collection of online resources that can help patient groups progress through the research and development process for new treatments.

PhenX Toolkit

The 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

REDCap is an easy-to-use, free tool for clinical study management and data capture, which provides investigators with the ability to build and manage online surveys and databases.

ResearchMatch

ResearchMatch provides a way to connect people trying to find research studies with researchers seeking participants for their studies. Supported by the CTSA Program, ResearchMatch is a free, secure registry, making it easier for the public to volunteer and to become involved in clinical research studies that contribute to improved human health.

Last updated on November 8, 2023