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Japan Society of Clinical Trials and Research ( JPT Supplement )

Vol. 50 Suppl. 2 2022

■ SYMPOSIUM

The Latest Global Trends of Decentralized Clinical Trial and the Role of Academia for Domestic Implementation in Japan

Yamamoto S.

Jpn Pharmacol Ther 2022; 50(s2): s93-95.


Implementation and Challenges of Fully Decentralized Clinical Trial:
A Study of App-based Intervention Study for Breast Cancer Patients

Mashiko T.

Jpn Pharmacol Ther 2022; 50(s2): s96-97.


History of the Decentralized Clinical Trials and System Challenges to Japan Implementation

Kachi K.

Jpn Pharmacol Ther 2022; 50(s2): s98-101.

■ PROPOSAL

Points to Consider for Operation and Management to Ensure the Reliability of
Registry Data for Use in Application Dossiers of Pharmaceuticals and Medical Devices

 AMED Research on Regulatory Science of Pharmaceuticals and Medical Devices
 Title of Research Project: Regulatory science research to achieve efficiency
 clinical research and development with the utilization of a patient registry
 [Grant Number: JP21mk0101154]

Oi H, et al.
Subgroup for “Review of the quality management system and points to consider”

Jpn Pharmacol Ther 2022; 50(s2): s129-153.

■ BRIEF REPORT

Use of Electronic Consent Forms in an Observational Pilot Study of Coronavirus Disease in Japan

Yu J.   Imai Y.   Nomura A.   Yoneda T.   Murayama T.

Jpn Pharmacol Ther 2022; 50(s2): s154-165.

■ CASE REPORT

The Questionnaire Survey for Understanding Current Situation of
Specified Clinical Research Based on the Clinical Trials Act at Fukushima Medical University Hospital

Murakami M.   Suzuki U.   Inoue R.   Takahashi T.   Noji S.
Watanabe C.   Matsumura Y.   Sano H.   Saito J.

Jpn Pharmacol Ther 2022; 50(s2): s166-171.

■ REVIEW ARTICLES

Cooperation of Industry and Academia to Accelerate Conduct of Clinical Research with Real World Data
—Investigation of the Next Generation Medical Infrastructure Law—

Meeting to Study the Utilization of Real-World Data and the Next Generation Medical Infrastructure Law:
Asai H.   Horimatsu T.   Kawahara N.   Wakabayashi Y.   Kuroda Y.
Ashida G.   Yoshida Y.   Kawahira G.   Suzaki Y.   Taruno H.

Jpn Pharmacol Ther 2022; 50(s2): s172-178.


Examination of Level-Specific Competencies Required for Academia Monitors

Hamazaki N.   Matsushima Y.   Inada M.   Hirase K.   Tai M.
Tamura N.   Shimada M.   Tanaka Y.   Hagimura K.   Yano M.
Kawai S.   Kondo N.   Okamoto Y.   Miura T.   Yamaguchi T.

Jpn Pharmacol Ther 2022; 50(s2): s179-201.