Vol.47, No.3, Feb. 2020
The 2nd meeting on the future perspective of the pharmaceutical industry utilizing Real-World Data and Digital Health /
Methodology of risk-benefit assessment and standardization of voting options in IRBs /
The mission and experience of layperson members of the IRB/EC in Korea and Japan
 
Contents
 
EditorialClinical Research
Risk Management Study Group
376-7Full 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
 Artificial intelligence (AI) in medical devices and post-marketing machine learningSuzuki T379-87Abstract
 Utilization of real world data to prove the value and safety of pharmaceuticalsMatsui N,Isshiki M389-98Abstract
 Awareness survey on Patient and Public Involvement (PPI)
  for Japanese drug development professional
Tsuda T,Okura M,
Fukuta Y,Imamura K
399-410Abstract
 
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.
411-48Abstract
 Opening RemarksKurihara C413-8
 Part 1: Risk-benefit assessment according to study phaseCho H
(Interpreter: Rhee Y, Kim CY.
 Cooperation: Yun JS)
419-38
 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
 ・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.
449-85Abstract
 Opening remarksKurihara C,Rhee Y451-3
 Part 1: Mission and experience in an Institutional Review Board in KoreaYoo S
(Interpreter: Rhee Y)
454-66
 Part 2: Mission and experience in Ethics Committees in JapanSaeki H467-79
 Part 3: Discussion with layperson members of IRB/EC in Korea and JapanYoo S,Rhee Y,
Saeki H,Kurihara C
480-5
 
Articles
 Single-session psychotherapy:
  Phenomenology of the critical turning point toward recovery
Saio T 487-500Abstract
 Conflict of interest disclosure backfires:
  Trend analysis on restriction of act and psychological experiments
Saio T,Kurihara C 501-18Abstract
 
Forum
 Problems of psychiatric care in NigeriaImamura O,Aremu F 519-22Full text
 
Instructions for authors[Japanese]&[English] 523-31Full text
 
Editor's noteSaio T533Full text


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