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New Regulatory Resource to Help Plan International Clinical Trials

Wednesday, January 21, 2015
ClinRegs (BETA): Aggregating clinical research regulations from around the globe

One of NICHD’s sister Institutes, the National Institute of Allergy and Infectious Diseases (NIAID) has launched ClinRegs, a public website to help clinical researchers at NIH and in the scientific community at large navigate country-specific, regulatory information as they plan and implement clinical trials. The site serves as a central resource that provides up-to-date regulatory information for multiple countries. Organized by country and topic area, the site also allows users to compare the requirements of two countries side-by-side.

“One of the challenges of building international clinical research collaborations—and NICHD supports many—is determining how clinical trials regulations compare for participating countries, said Vesna Kutlesic, Ph.D., director of NICHD’s Office of Global Health. “This website offers a one-stop shop for researchers to access and compare important regulatory information when designing clinical trials involving several countries.”

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, South Africa, Tanzania, Thailand, Uganda, the United Kingdom, and the United States. The ClinRegs team plans to further expand its country list, including adding to information on Liberia and incorporating regulations from Sierra Leone 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. The Institute welcomes comments, insights, and suggestions via its feedback survey on the website. To access the ClinRegs site, go to clinregs.niaid.nih.gov.

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About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute's website at http://www.nichd.nih.gov/.

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