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Japan Society of Clinical Trials and Research ( JPT Supplement )

Vol. 42 Suppl. 1 2014

■Symposium:Japan Society of Clinical Trials and Research (JSCTR) and Association of Clinical Research Professionals (ACRP) Joint Seminar
Monitoring of Clinical Trials and Research
―Risk Based Approach for Monitoring―

【Case Report 1】
The Model of Operation of Centralized Monitoring in US and Asia Pacific

J. Louie

Jpn Pharmacol Ther 2014 42(s1) s7-11


【Case Report 2】
Oversight of Clinical Investigation ─Risk Based Monitoring

Y. J. Choi

Jpn Pharmacol Ther 2014 42(s1) s12-4


【Case Report 3】
Monitoring of Clinical Trials and Global Clinical Trials
Conducted by a Cancer Cooperative Study Group

T. Shibata

Jpn Pharmacol Ther 2014 42(s1) s15-22

■ORIGINAL ARTICLES

A Survey on Biostatistical Consulting at Japanese Medical Institutes

N. Tanaka, et al.

Jpn Pharmacol Ther 2014 42(s1) s33-44

■CASE REPORT

Investigation of Relationship between Investigational New Drug and Serious Adverse Events during Clinical Trials

H. Ikeda, et al.

Jpn Pharmacol Ther 2014 42(s1) s45-9


Outcome of Computerized Methods on the Automatic Distribution Service of the Temperature Log by Using Mailing List in Clinical Trials Including ICH-GCP

Y. Shen, et al.

Jpn Pharmacol Ther 2014 42(s1) s50-4