NIAID ClinRegs-a Public Database of Country Clinical Research Regulatory and Ethics Requirements: Design and Utilization Analysis.

ABSTRACT: Regulatory compliance is challenging for multinational clinical trials. Conflicts between country requirements impedes research and slows the approval of medicines, leading the pharmaceutical industry to devote significant resources to this area. Many academic centers and nonprofits cannot support industry-level investment and are vulnerable to noncompliance. To address an insufficiency in public access to this information, the National Institute of Allergy and Infectious Diseases developed ClinRegs-a public access database of clinical research regulations. This report describes ClinRegs' features, maintenance, and usage. From September 2019 through August 2020, ClinRegs had 68 504 users, 60% from outside the United States, demonstrating the demand for accessible, reliable, country-specifi

SUBMITTER: Kagan J 

PROVIDER: S-EPMC8492127 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature