NATIONAL CANCER INSTITUTE - CANCER.GOV

Contact Information


Primary Contact

Aaron Neal, D. Phil.
NIAID Lead for ClinRegs

Location

5601 Fishers Lane
Rockville, MD 20852

Additional Contacts

Geoffrey Goodman
ClinRegs Project Manager
Rachel Oh
ClinRegs Deputy Project Manager

Overview

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. ClinRegs is a free and publicly available informational resource and does not provide direct consulting or regulatory support services. 

Information Available

Countries and topics are included based on NIAID’s international clinical research priorities.

Country-specific regulatory information is organized by the following topic areas:

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

The single-country profile view provides a summary of the requirements for each topic section. The comparison view provides a side-by-side view of the topic summaries for up to four countries.

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.

User Guidelines

ClinRegs is free and open to the public.

Publications

  • 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

Keywords

regulationclinical researchclinical trialinternational