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Japan Society of Clinical Trials and Research ( JPT Supplement )

Vol. 44 Suppl. 2 2016

■ SYMPOSIUM

【1 Status and Network of Investigator-initiated Clinical Trials】

Current Status of Investigator Initiated Trials through the Pediatric Clinical Trials Network

T. Kuriyama

Jpn Pharmacol Ther 2016 44(s2) s90-3


Translational Research Network Program: The Project of Networking

M. Aoki

Jpn Pharmacol Ther 2016 44(s2) s94-9


【2 Multicenter Registry Data and Bayesian Approach】

Utilization of Disease Registry Data and Bayesian Approach for Drug Developments

A. Hirakawa

Jpn Pharmacol Ther 2016 44(s2) s100-1


Design of Clinical Research Using Rare Diseases Registry

A. Kada

Jpn Pharmacol Ther 2016 44(s2) s102-4


Bayesian Approach to Utilize Historical Data in Clinical Trials

K. Takeda

Jpn Pharmacol Ther 2016 44(s2) s105-8


【3 Monitoring in Academic Clinical Trials: Reports from Monitors】

Introduction: Concept of Monitoring in Clinical Research

K. Hagimura

Jpn Pharmacol Ther 2016 44(s2) 109-11


Education of Researchers for Monitoring

M. Inada

Jpn Pharmacol Ther 2016 44(s2) s112-4


How Is “Monitoring Activities” Performed by a Clinical Research Coordinator?

S. Ando

Jpn Pharmacol Ther 2016 44(s2) s115-7


Report of Monitoring Support in Investigator-initiated Clinical Research from the Quality Management Sub-working Group

A. Watanabe

Jpn Pharmacol Ther 2016 44(s2) s118-21

■BRIEF REPORT

Development of the New Risk Assessment Tool for Quality Insurance in Clinical Trials

K. Matsuyama, et al.

Jpn Pharmacol Ther 2016 44(s2) s131-9


Differences in Management of the Safety Information by Each Regulations in Clinical Trials in Japan

Y. Takeuchi, et al.

Jpn Pharmacol Ther 2016 44(s2) s141-9

■CASE REPORT

Development of an Efficient Monitoring Method for Investigator-initiated Clinical Trials: Lessons from the Experience of ATACH-ⅡTrial

K. Hirase, et al.

Jpn Pharmacol Ther 2016 44(s2) s150-4


Establishment of a Programming Training of R Beginner-Oriented Specialized for Effective Data Handling

N. Ito, et al.

Jpn Pharmacol Ther 2016 44(s2) s155-60