About
 

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID)’s ClinRegs website is an online database of country-specific, clinical research regulatory information. By providing well-documented and current information in a single place, ClinRegs serves as a central resource and time-saver for persons involved in planning and implementing international clinical research.

Information Available

ClinRegs provides country-specific regulatory information in the following topic areas:

  • Regulatory Authority
  • Ethics Committee
  • Clinical Trial Lifecycle
  • Sponsorship
  • Informed Consent
  • Investigational Products
  • Specimens

In a single-country view, content within each topic is organized by sections, which provide a summary of the requirements, links to regulatory documents, and links to other related information (where available).

In comparison view, which is accessible from within a country page, the section content is abridged to facilitate ease of viewing.

When available, ClinRegs provides English versions of regulatory documents. English translations from sources other than a regulatory authority are designated “unofficial.” When more than one language is available, users can select from the hyperlinked options.

Users requiring assistance locating specific regulatory information or with questions about the site should contact the ClinRegs team by clicking the Contact Us link at the top of each page.

Countries and topics are included in ClinRegs based on NIAID’s international clinical research priorities. Users are welcome to recommend additional countries or topics to be considered for inclusion.

To receive the latest ClinRegs information, users can subscribe to country- or topic-specific email updates via GovDelivery.

Content Development and Maintenance

The ClinRegs team—comprised of regulatory, legal, and policy analysis experts—reviews and analyzes regulatory authority information to develop the website content. To ensure fidelity, accuracy, and consistency, all content is vetted by country-specific subject matter experts and edited for clarity and style.

On average, country content is reviewed and, if necessary, updated yearly.  However, updates may be issued more frequently, particularly to incorporate substantial, timely changes to country regulations or requirements. Users are encouraged to share their expertise by using the Submit Updates or Comments link within each section, or via the Contact Us link at the top of each page.

Broken links are identified and fixed on a monthly basis.

Governance

ClinRegs is a NIAID Executive Committee-approved project developed under NIAID’s Barriers to Clinical Research initiative. Management responsibility for ClinRegs resides principally in the Division of Clinical Research (DCR) with guidance from the ClinRegs Steering Group (ClinRegs SG), a subcommittee of the NIAID Clinical Research Subcommittee. The ClinRegs SG is comprised of NIAID divisional representatives with expertise in international clinical research. Representatives are responsible for providing input, guidance, and prioritization for the site’s content, features, and functionality based on the interests, needs, and preferences of their respective NIAID divisions. The ClinRegs SG also serves as the site’s change control board.

Internet Browser Compatibility

ClinRegs is optimized for performance in Google Chrome, Safari, Internet Explorer, and Firefox. If you encounter problems with the display or functionality, please let us know by using the Contact Us link at the top of each page.

Disclaimer

Content: Although ClinRegs contains information of a legal nature, it is intended for informational purposes only. It does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction, including the United States. The Federal Register and the Code of Federal Regulations remain the official sources for regulatory information published by the United States. While every effort is made to provide accurate and complete information, the laws, regulations, and guidelines referenced are often complex and may provide more details than are provided on this site. Also, since new standards are issued on a continuing basis, NIAID cannot guarantee that this site is free of inaccuracies and reflects the most current information available. Users should check with local authorities and/or research ethics committees before commencing research activities.

When a country’s regulatory requirements are not available in English, the content provided is developed using unofficial sources or automated translation services.

Occasionally this site houses country-specific regulatory documents when they are otherwise not available online. These documents may not be Section 508 compliant, in which case users should contact the documents’ authors to request accessible versions.

Links to External Websites and Documents: This site contains links to non-U.S. Government websites and documents, which are provided for the convenience of the user. Such use does not constitute an official endorsement or approval by NIAID of any external website, document, product, or service. Users are subject to the external site's privacy policy when leaving this site. We are not responsible for Section 508 compliance on other federal or private websites or documents.

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OMB #: 0925-0668
Expiration Date: 2/28/2019