Turn to ClinRegs for Country-Specific Clinical Trial Research Requirements

Funding News Edition: May 15, 2019
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In September 2014, NIAID launched ClinRegs, a free online database of international clinical trial regulations. Since then, ClinRegs has become a go-to resource for country-specific, clinical trial regulatory information, with more than 68,000 users from 157 countries.

ClinRegs serves as a “one-stop shop” for country regulatory information. The site is easy to navigate with a table of contents covering topics such as regulatory authority, ethics committee, clinical trial lifecycle, and sponsorship. ClinRegs also provides details such as regulatory authority contact information and estimated application review and approval times.

Each country regulatory profile contains:

  • Concise, comprehensive summaries of country requirements written in English
  • A quick facts table for answers to frequently asked questions
  • Direct links to regulations on the country’s regulatory authority websites
  • A country comparison feature for displaying the regulations for two countries side-by-side

Subject matter experts with firsthand country knowledge work closely with the ClinRegs team to help assure accuracy. 

ClinRegs currently includes 20 countries (highlighted in green on the map below). Countries are added based on NIAID research priorities. In 2019, the ClinRegs team will add Democratic Republic of the Congo.

 

ClinRegs Map

ClinRegs currently includes 20 countries (highlighted in green). In 2019, the ClinRegs team will add Democratic Republic of the Congo.

Credit
NIAID

Users may receive real-time updates of regulatory changes in each country by subscribing to ClinRegs GovDelivery email updates. Users can also reach the ClinRegs team directly by clicking the Contact Us button on the top right of the website or emailing NIAIDClinRegsSupport@mail.nih.gov.

Additionally, the NIAID ClinRegs team thanks the subject matter experts and organizations listed on the Acknowledgements page for providing country-specific regulatory information and confirmations of accuracy for the ClinRegs country profiles.

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