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The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), has launched ClinRegs, a public website designed to help clinical researchers navigate country-specific regulatory information as they plan and implement clinical trials. Organized by country and topic area, the site also allows users to compare the requirements of two countries side-by-side.
Topic areas addressed on the website include clinical trial lifecycle, competent authority oversight, ethics committee oversight, informed consent, investigational products, specimens, and sponsorship.
ClinRegs currently includes clinical research regulatory information summarized in English for Brazil, China, India, Kenya, Liberia, Malawi, Peru, Sierra Leone, South Africa, Tanzania, Thailand, Uganda, United Kingdom and the United States. The ClinRegs team plans to further expand its country list in alignment with NIAID research priorities, including Guinea, Mali, Mexico, and Vietnam.
NIAID plans to review regulations for each country on a regular basis-approximately once per year-and more often if it learns of major regulatory changes. NIAID strives to make ClinRegs a useful resource for and the clinical research community and welcomes comments, insights, and suggestions via its feedback survey on the website. To access the ClinRegs site, go to clinregs.niaid.nih.gov.