Science Links Japan | Problems in Clinical Tests: What Can Be Done Now and What Should Be Done. Improving the Infrastructure for Clinical Trials in Japan.

Problems in Clinical Tests: What Can Be Done Now and What Should Be Done. Improving the Infrastructure for Clinical Trials in Japan.

Accession number;99A0225248

Title;Problems in Clinical Tests: What Can Be Done Now and What Should Be Done. Improving the Infrastructure for Clinical Trials in Japan.

Author; NAKANO SHIGEYUKI (Oita Med. Univ.)

Journal Title;Japanese Journal of Cancer and Chemotherapy

Journal Code:Z0938A

ISSN:0385-0684

VOL.26;NO.2;PAGE.225-230(1999)

Figure&Table&Reference;TBL.6, REF.4

Pub. Country;Japan

Language;Japanese

Abstract;It is necessary for us to reform the infrastructure for clinical trials in Japan in this new GCP era. Medical institutions for clinical trials should prepare to implement monitoring and auditing procedures for quality control and quality assurance of clinical trials. It is also necessary to ease the burden and improve the benefits of participating in clinical trials by subjects. Although there has been no effort to educate and train CRC/SC staff at all in Japan, future improvement in this area is needed to bring the quality of Japan's clinical trials up to international standards. (author abst.)

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