NIH Launches Online Database of International Clinical Research Regulations

New Public Resource to Help Researchers Explore Country-Specific Requirements
September 9, 2014

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 the NIAID Division of Clinical Research, is available to discuss the ClinRegs website.
 
CONTACT:
To schedule interviews, please contact Hillary Hoffman, (301) 402-1663, niaidnews@niaid.nih.gov.
Content last reviewed on September 9, 2015