An official website of the United States governmentNCCIH Clinical Research Toolbox
The NCCIH Clinical Research Toolbox provides a web-based information repository for investigators and staff involved in NCCIH-funded clinical research. The Toolbox is a one-stop shop for required templates, sample forms, and information materials to assist clinical investigators in the development and conduct of high-quality clinical research studies. The Toolbox also contains detailed instructions on the submission of required documents by oversight level and links to helpful policy, guidance, and web-based resources for NCCIH grantees.
What is my oversight level?
For grants considered for funding, the NCCIH program directors in the Division of Extramural Research will communicate with the principal investigator(s) following the release of the summary statement in a Request for Clarifications Letter. The NCCIH Request for Clarifications Letter will specify the oversight level, request clarification of study-specific questions, and outline next steps. For specific information, view the Oversight Levels page.
Are there special requirements for NCCIH-funded studies that involve a regulated product or device?
Studies that propose the use of products and devices regulated by the U.S. Food and Drug Administration (FDA) or U.S. Drug Enforcement Administration (DEA) must complete the NCCIH Regulatory Tracking Form with details about the Investigational New Drug (IND) application, Investigational Device Exemption (IDE), or DEA-controlled substance. NCCIH requires information on each product, including placebo if applicable, proposed for use in your study. For specific information, view the Regulated Products and Devices: Additional Requirements page.
NCCIH requires independent monitoring for clinical studies. What resources are available?
NCCIH is responsible for overseeing the data and safety monitoring (DSM) of the clinical research it supports and has developed policies, guidelines, and resources to assist grant applicants in developing DSM plans, including selecting an independent monitoring entity, in accordance with NIH requirements. For specific information, view the Data and Safety Monitoring Resource page [123KB Word file].
Learn about the rationale for NCCIH oversight; the different oversight levels; and what is expected prior to initiating your clinical research by level. This new resource will help you improve the ability to plan for initiation of your clinical study once you receive a notice of an award.