●Editorial | Clinical Research Risk Management Study Group | 376-7 | Full text | |
●Clinical Research Risk Management Study Group Digital Health Seminar The 2nd meeting on the future perspective of the pharmaceutical industry utilizing Real-World Data and Digital Health |
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Artificial intelligence (AI) in medical devices and post-marketing machine learning | Suzuki T | 379-87 | Abstract | |
Utilization of real world data to prove the value and safety of pharmaceuticals | Matsui N,Isshiki M | 389-98 | Abstract | |
Awareness survey on Patient and Public Involvement (PPI) for Japanese drug development professional | Tsuda T,Okura M, Fukuta Y,Imamura K | 399-410 | Abstract | |
●Clinical Research Risk Management Study Group Seminar | ||||
・Methodology of risk-benefit assessment and standardization of voting options in IRBs: Learning from AAHRPP-accredited Samsung Medical Center Organizes and cooperators:Kurihara C; Clinical Research Risk Management Study Group; Mitsui Sumitomo Insurance; Rinsho Hyoka Kankokai, Inc. |
411-48 | Abstract | ||
Opening Remarks | Kurihara C | 413-8 | Full text | |
Part 1: Risk-benefit assessment according to study phase | Cho H (Interpreter: Rhee Y, Kim CY. Cooperation: Yun JS) | 419-38 | Full text | |
Part 2: Standardization of voting options in IRBs: Approved, minor revision required, and not approved | Cho H (Interpreter: Rhee Y, Kim CY. Cooperation: Yun JS) | 439-48 | Full text | |
・The mission and experience of layperson members of the IRB/EC in Korea and Japan: Participating in discussion and voting as representatives of the citizenry, society, and patients Organizes and cooperators:Kurihara C; Clinical Research Risk Management Study Group; Mitsui Sumitomo Insurance; Rinsho Hyoka Kankokai, Inc. |
449-85 | Abstract | ||
Opening remarks | Kurihara C,Rhee Y | 451-3 | Full text | |
Part 1: Mission and experience in an Institutional Review Board in Korea | Yoo S (Interpreter: Rhee Y) | 454-66 | Full text | |
Part 2: Mission and experience in Ethics Committees in Japan | Saeki H | 467-79 | Full text | |
Part 3: Discussion with layperson members of IRB/EC in Korea and Japan | Yoo S,Rhee Y, Saeki H,Kurihara C | 480-5 | Full text | |
●Articles | ||||
Single-session psychotherapy: Phenomenology of the critical turning point toward recovery | Saio T | 487-500 | Full text | |
Conflict of interest disclosure backfires: Trend analysis on restriction of act and psychological experiments | Saio T,Kurihara C | 501-18 | Full text | |
●Forum | ||||
Problems of psychiatric care in Nigeria | Imamura O,Aremu F | 519-22 | Full text | |
●Instructions for authors[Japanese]&[English] | 523-31 | Full text | ||
●Editor's note | Saio T | 533 | Full text |