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After launching as a free online resource for country-specific, clinical research regulatory information in 2014, ClinRegs has grown to over 68,000 users from 157 countries.
The National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) launched ClinRegs in 2014 as a free online resource for country-specific, clinical research regulatory information. Since then, the site’s reach has grown extensively, with over 68,000 users from 157 countries.
NIAID describes ClinRegs as a “timesaving resource for persons involved in planning and implementing international clinical research.” The site provides up to date information on a wide range of specific topic areas, such as clinical trial lifecycle, regulatory authority, ethics review, informed consent, investigational products, specimens, and sponsorship.
Users can look up clinical trial requirements for 20 countries-as highlighted in green on the map below-including Australia, Brazil, China, India, South Africa and Thailand. The Democratic Republic of Congo is scheduled to be added later in 2019.
Countries Included in ClinRegs
Key benefits for users of the ClinRegs site are the accessibility of its content and its trustworthiness. ClinRegs presents regulatory information in a way that is comprehensive and understandable, offering features such as side-by-side country comparisons. For example, when comparing South Africa and Brazil, a user would be provided with a short explanation of each country’s regulatory authority and detailed information about clinical trial application requirements and timeline. Regulations are written in plain English with a Quick Facts chart providing at-a-glance summary regulatory data at the top of each country page.
In addition to providing clear descriptions of country-specific, clinical research requirements, ClinRegs provides links to official regulatory and guidance documents. While not all documents are available in English, ClinRegs provides translations when available.
ClinRegs staff work closely with country subject matter experts who review the content for accuracy and currency. Each section also includes the latest review date. ClinRegs users are encouraged to submit comments and suggest updates using the feedback survey and the comment tools on the site.
Jonathan Kagan is the Assistant Director for Speical Projects in the Division of Clinical Research, National Institute of Allergy and Infectious Diseases, NIH, DHHS. Darcie Gladden is an Advisor at GDIT. Marie Tummarello is a Data Analyist for GDIT.