Japan Society of Clinical Trials and Research ( JPT Supplement )
Vol. 51 Suppl. 1 2023
SYMPOSIUM：Accreditation, Education, and Career Paths for Clinical Research Professionals
1 Current Status of the Accreditation System in JSCTR
──GCP Passport® / GCP Expert® / Cancer Clinical Research Profession
H. Taruno
Jpn Pharmacol Ther 2023; 51(s1): s7-9.
2 Status of Study Manager (StM) Certification System
K. Iwasaki
Jpn Pharmacol Ther 2023; 51(s1): s10-13.
3 Development of the Clinical Data Manager Certification Program in JSCTR
M.Takata H. Kuramoto K. Fujisawa M. Nashimoto S. Kanda
T. Miyaji M. Nishi H. Suganami T. Yamaguchi
Jpn Pharmacol Ther 2023; 51(s1): s14-17.
4 Progress in Establishment of Monitor Certification System
Y. Matsushima
Jpn Pharmacol Ther 2023; 51(s1): s18-20.
SYMPOSIUM：Points to Think about in the Early Stages of Programmed Medical Device Development
1 Considerations in the early stages of SaMD development process
K. Mamada
Jpn Pharmacol Ther 2023; 51(s1): s22-24.
2 Points to Consider When Consulting with PMDA
K. Kato
Jpn Pharmacol Ther 2023; 51(s1): s25-27.
■ ORIGINAL ARTICLE
Study on Operational Efficiency of Management of the Safety Information
Using Cloud System in Investigator-initiated Clinical Trials
S. Takemori N. Hosogaya Y. Fukushige S. Morimoto
C. Fukushima H. Yamamoto
Jpn Pharmacol Ther 2023; 51(s1): s32-37.