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