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Japan Society of Clinical Trials and Research ( JPT Supplement )

Vol. 41 Suppl. 1 2013

■REVIEW Standardization of Electronic Information which Forms Basis of Clinical Research

【Part 1: Ready to Use "CDISC Standards" ? -Current Status and Future in Japan】

1 The Overview of CDISC Standards, and Intention of This Special Feature

H. Ohtsu

Jpn Pharmacol Ther 2013 41(s1) s6-9


2 CDISC -Approach and Challenges in Japan

Y. Tsukada

Jpn Pharmacol Ther 2013 41(s1) s10-2


3 Approach to CDISC Standards in Japanese Academia

T. Kiuchi

Jpn Pharmacol Ther 2013 41(s1) s13-8


4 The Activities and Future of CJUG (CDISC Japan User Group)

1) SDTM (Study Data Tabulation Model)

Y. Chiba

Jpn Pharmacol Ther 2013 41(s1) s19-23

2) ADaM (Analysis Data Model)

Y. Asami

Jpn Pharmacol Ther 2013 41(s1) s24-8


【Part 2:Developing Postmarketing Surveys and Clinical Investigations Using SS-MIX Standardized Storage】

Consideration of “Recommendations for Developing Postmarketing Surveys and Clinical Investigations Using SS-MIX Standardized Storage”

Y. Ohtsu, Y. Ohashi

Jpn Pharmacol Ther 2013 41(s1) s29-33


Recommendations for Developing Postmarketing Surveys and Clinical Investigations Using SS-MIX Standardized Storage

K. Kubota, et al.

Jpn Pharmacol Ther 2013 41(s1) s34-40

■ORIGINAL ARTICLES

【CASE REPORT】

Utilization of Project Management in Department of Data Management for Support of Investigator-Initiated Clinical Trials

Y. Kai, et al.

Jpn Pharmacol Ther 2013 41(s1) s50-4


【CASE REPORT】

Construction and Present Situation of HTR Net
-Toward the Largest Clinical Trial Infrastructure in Japan within Hokkaido-

K. Nakamura, et al.

Jpn Pharmacol Ther 2013 41(s1) s55-61