Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
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Original Article
  • Yoshihiko IIJIMA
    Type: research-article
    2021 Volume 52 Issue 2 Pages 21-27
    Published: March 31, 2021
    Released: April 14, 2021
    JOURNALS RESTRICTED ACCESS

    According to the Clinical Trials Act, which has been enacted since 2018, the Certified Review Board (CRB) has to refer to written opinions of technical experts. The system of technical experts is new, and its actual state and function are still unclear. Here, we conducted a questionnaire survey with 70 participating CRB offices across the country, and a field survey with 12 CRB offices, attempting to clearly show the actual state and issues the technical experts face. Each research institution performs a variety of operations in relation to existing Academic Research Organization (ARO). In the future, it is required that the operations of technical experts make a high-quality review by a CRB.

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Proceedings of the 41st Annual Meeting of the Japanese Society of Clinical
AS1 “Pharmacology/Clinical Pharmacology Research Aiming at Advanced Drug Development”
AS5 “Data-driven Basic and Clinical Pharmacology Research”
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