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Vol. 41 Suppl. 2 2013

■ SYMPOSIUM

【Symposium 1 ：Quality of Life in Clinical Trials and Economic Evaluation】

Introduction
Quality of Life in Clinical Trials and Economic Evaluation

Y. Ohashi

Jpn Pharmacol Ther 2013　41(s2) s74-5

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Health-Related Quality of Life Assessment in Clinical Trial

N. Taira

Jpn Pharmacol Ther 2013　41(s2) s76-8

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Development Program for the Japanese Version of the PRO-CTCAE

T. Yamaguchi

Jpn Pharmacol Ther 2013　41(s2) s79-82

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【Symposium 2 What the Monitoring for Clinical Trials in Japan should be.】

Current Status of Monitoring in Investigator-initiated Trials with IND

C. K. Imamura

Jpn Pharmacol Ther 2013　41(s2) s84-7

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The Current Status of Monitoring for Industry-sponsored Clinical Trials and Investigator-initiated Clinical Trials in Japan

H.Oi

Jpn Pharmacol Ther 2013 41(s2) s88-91

■ORIGINAL ARTICLE

Association between Quality of Local Data Management and CRC Support / the Number of Registered Cases of an Investigator-initiated Clinical Trial

K. Murayama, et al.

Jpn Pharmacol Ther 2013　41(s2) s103-10

■CASE REPORT

A Proposal for Optimization of Clinical Trial by Central Monitoring System
－Consolidation by Applying the Operation Center and Electronic Data Sharing System －

Working Group 03 of the Monitoring 2.0 Group

M. Kitagawa, et al.

Jpn Pharmacol Ther 2013　41(s2) s111-20

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Analysis of the Questions and Consultations Relevant to Clinical Studies in Osaka University Hospital

N. Yamamoto, et al.

Jpn Pharmacol Ther 2013　41(s2) s121-7

■REVIEW ARTICLE

Clinical Safety Data Management in Investigator-Initiated, Oncology Clinical Trials

T. Hata, et al.

Jpn Pharmacol Ther 2013　41(s2) s128-36