The Clinical Research Regulations database (ClinRegs) is, “an online public database of country-specific clinical research regulatory information.”. It was created and is maintained by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health.
ClinRegs is, “an online public database of country-specific clinical research regulatory information.”
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.
From the ClinRegs About Page:
ClinRegs provides an overview of country-specific regulations in the following topic areas:
- Competent Authority Oversight
- Ethics Committee Oversight
- Clinical Trial Lifecycle
- Informed Consent
- Investigational Products
Direct to ClinRegs
See Also: User Guide (1 page; PDF)