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