WHAT:
The National Institutes of Health (NIH) today launched ClinRegs , an online public database of country-specific clinical research regulatory information. The ClinRegs website, created and maintained by NIH's National Institute of Allergy and Infectious Diseases (NIAID), enables users to explore and compare regulations across different countries.
By providing up-to-date regulatory information for multiple countries, ClinRegs serves as a resource and potential time-saver for people involved in planning and implementing international clinical research. Regulatory requirements can present hurdles to approval and implementation of international research projects. ClinRegs aims to make it easier for investigators to find and understand country-specific requirements on topics such as clinical trial application submission and ethics committee approvals.
ClinRegs enables users to review country-specific regulatory requirements and compare requirements between countries in seven topic areas, including informed consent practices and trial sponsorship. The growing database currently includes information for 12 countries, and NIAID plans to add regulatory information for additional countries in the future.
WHO:
Jonathan Kagan, Ph.D., Assistant Director for Special Projects in NIAID's Division of Clinical Research, is available to discuss the ClinRegs website.
CONTACT:
To schedule interviews, please contact Hillary Hoffman, (301) 402-1663, hillary.hoffman@nih.gov.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
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