Evaluation of Education System for Clinical Trial
Investigators
Fumi Masumoto1) , Yasunori Ichiba1),2) , Taizo Hirata1),3) , Yoshinori Yamashita1),4) , Kiyomi
Taniyama5)
1) Clinical Trial Office, 2) Department of Pharmacy , 3) Department of Medical Oncology, 4) Institutefor Clinical Research ,5) President,
National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Japan

Background

Roles of the Clinical Trial Office of NHO Kure Medical Center/
Chugoku Cancer Center (KMCCCC)

Several cases of misconduct inresearch have occurred over theyears in Japan.
Under new guidelines, measures
have been taken to have a
researcher’s institution assume
greater responsibility and create
anenvironment
toreduce
misconduct. One effort is toenhance researcher integrity byconducting education.

Objective

Clinical Trial and Research at KMCCCC

To demonstrate theimpact of the clinicalresearch
educationsystem at KMCCCC on
the development ofquality management.
It is expected thatinvestigators
whoinitiate clinical trials will
ensurehighdata
quality.

The Clinical Trial Office of KMCCCC is in the position of
supporting and educating new investigators andresearch staff to ensure high data quality.

Methods
A retrospective review was performed of allclinicaltrialaudits
conductedby
Pharmaceuticals and Medical Devices
Agency(PMDA), Japan Cooperative Oncology
Group(JCOG),
NRG
oncology,andcooperative groups from 2011 to 2015. The
audit findings was compared between before
and after the implementation of the clinicalresearch education system. Deviation basedon GCP, Ethical Guidelines for ClinicalResearch,andresearch
protocolrequirements were categorized as follows:Failure to follow the protocol
Data integrity
Enrollment of ineligible subject
IRB submission issueInformed consent problem
Delay in reporting SAE/UAP

Education Systems• Regularly held 2-3 seminars a year on
clinical research at our hospital.
• Since 2013, invited a leading expert in
the field to lecture at least once a year.
• Since 2013, provided certificates toseminar attendees.
• Since 2013, required investigators toreceive education on the ethics ofresearch and the knowledge and skills
necessary to carry out the research.
• If an investigator could not attend theseminars, required them to complete ane-learning course prior to commencing
research .

Process to start
clinical trial

Education Contents

Investigator• GCP• Ethical Guidelines for Medical andHealth Research Involving Human
Subjects• Responsible Conduct of ResearchResearch MisconductData HandlingConflict Of Interest
Managing Public ResearchFunds• Research Involving Human
Subjects
Ethical Review Committee
Informed Consent
Personal Information, etc.

ClinicalResearch
Education

IRB(InstitutionalReview Board)

Clinical TrialStart

Results
Seminar attendees and investigators
who completed the e-learning

Self-reported understanding byseminar attendees in 2015

Audit findings by regulating authority andleading cooperative groups

N:82
Medical staff; nurse, pharmacist, or others.

Conclusion
Since implementation of the educational system, negative audit findings have been reduced by 65%.
These results indicate that the education system is effective in ensuring high data quality.