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FDA regulations and guidance documents are accessible from this site as well as international GCP guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance.
From study design to participant recruitment and engagement, the Trial Innovation Network continues to add self-service tools and resources to help investigators throughout the entire life cycle of their projects.
The Office of Research and Development (ORD) aspires to discover knowledge, develop VA researchers and health care leaders, and create innovations that advance health care for our veterans and the nation.
The CCTS collaborated with members of the Office of the OVCR Quality Improvement Program to develop a set of standard case report forms. The forms should be useful for any investigator initiated clinical trials and can be customized to an individual study.
The Partners.org virtual Regulatory Binder assists research sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research.
Investigators who need to translate a research protocol into lay language for informed consent documents and/or IRB submission may benefit from the University of Michigan’s "Simplification Guide to Medical Terms."
The purpose of the NIH Clinical Research Toolbox is to provide a Web-based information repository for investigators and staff involved in clinical research.
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Investigators can learn more about national clinical studies, including relevant history, policies, and laws.