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Welcome
ClinRegs is an online database of country-specific clinical research regulatory information designed to assist in planning and implementing international clinical research. Countries are included based on NIAID's international clinical research priorities.
If a country you are looking for is not included in ClinRegs, consider the following resources:
- US. Department of Health and Human Services International Compilation of Human Research Standards
- European Clinical Research Infrastructure Network’s Regulatory & Ethical Database (RED)
ClinRegs Informational Resources:
Check out the following informational resources to learn more about ClinRegs:
- ClinRegs fact sheet
- May 2024 webinar recording: Utilizing NIAID’s ClinRegs Website to Support International Clinical Research Regulatory Compliance (see PDF for accessible version of presentation)
- NIAID ClinRegs—a Public Database of Country Clinical Research Regulatory and Ethics Requirements: Design and Utilization Analysis, Clinical Infectious Diseases, Volume 73, Issue 7, 1 October 2021, Pages 1296–1301, https://doi.org/10.1093/cid/ciab505
Updates
Malawi Profile Updated
Aug 29, 2024 - The Malawi profile in ClinRegs has been reviewed and updated with the following information:Data protection requirements related to the processing of personal data and the rights of data subjects (See Personal Data Protection)Additional details and requirements related to the import of investigational ...
US Profile Updated with FDA Rule on Informed Consent Exceptions
Aug 27, 2024 - The United States profile in ClinRegs has been updated to include the Food and Drug Administration (FDA)'s final rule on informed consent exceptions for minimal risk clinical investigations, which took effect on January 22, 2024 (See Documentation Requirements). Sources ...
Brazil Profile Updated
Aug 23, 2024 - The Brazil profile in ClinRegs has been reviewed and updated with the following information:2024 legislation on principles, guidelines, and rules for conducting research with human beings and establishing the National System of Ethics in Research with Human Beings (See Oversight of Ethics Committees ...
Canada Profile Updated
Jul 26, 2024 - The Canada profile in ClinRegs has been reviewed and updated with the following information:Health Canada (HC) guidance on filing submissions electronically, including electronic Common Technical Document (eCTD) submission, non-eCTD electronic submission, and validation rules (See Submission ...