| Item type |
文献 / Documents(1) |
| 公開日 |
2018-05-18 |
| アクセス権 |
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|
アクセス権 |
open access |
| 資源タイプ |
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|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 出版社版DOI |
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|
識別子タイプ |
DOI |
|
|
関連識別子 |
https://doi.org/10.2152/jmi.58.81 |
|
|
言語 |
ja |
|
|
関連名称 |
10.2152/jmi.58.81 |
| 出版タイプ |
|
|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| タイトル |
|
|
タイトル |
View and present status of personnel involved in clinical trials : a survey of participants from the First Symposium of the Shikoku Collaborative Group for Promotion of Clinical Trials |
|
言語 |
en |
| 著者 |
楊河, 宏章
苛原, 稔
ホウチ, ヒトシ
カケヒ, ヨシユキ
モリトヨ, タカシ
ノモト, マサヒロ
ミヤムラ, ミツヒコ
シュウイン, タロウ
the Shikoku Collaborative Group for Promotion of Clinical Trials
| en |
the Shikoku Collaborative Group for Promotion of Clinical Trials
|
Search repository
|
| 抄録 |
|
|
内容記述タイプ |
Abstract |
|
内容記述 |
Clinical trials leading to drug approval (registration trials) play a central role in the drug development process. Since the introduction of the Good Clinical Practice (GCP) standard in 1997, the Japanese infrastructure for registration trials has improved. The contribution of support staff, including clinical research coordinators (CRCs), to clinical trials is now widely recognized in Japan. Quality issues and career development for these support staff are being increasingly emphasized. The Shikoku Collaborative Group for Promotion of Clinical Trials was organized in 2008 to address these issues through communication with the personnel involved in clinical trials in regional areas of Japan. To understand the views and present status of personnel involved in clinical trials, we used questionnaires to survey the participants of the First Symposium of the Shikoku Collaborative Group for Promotion of Clinical Trials held in August 2009. Group discussions and special lectures occurred at the symposium. The questionnaire began with questions about basic patient characteristics, followed by practical questions. Of 110 participants, there were 68 respondents (62%), including clinical trial support staff (clinical research coordinators [n=36, 53%], administrative officers [n=9, 13%]), and medical staff [n=23, 34%]). Among the support staff, 36 (80%) had more than 5 years of experience. The most common questionnaire answer selected for participation in the symposium was “willing to contact staff from other medical institutions or organizations” for support staff and “to obtain further knowledge concerning clinical trials” for medical staff. The overall view of the discussion (“Was the discussion satisfactory?”) was favorable for 36 (53%) respondents. This survey revealed that the group discussion in the present symposium appears to be valuable for participants, using overall satisfaction as a surrogate. Based on the information obtained in the present study, further development of the clinical trial infrastructure, including training opportunities and career development for support staff, is required. Due to the limitations of this study, further analysis is warranted to determine the optimal strategy for training support staff. |
|
言語 |
en |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
clinical trial |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
clinical research coordinator |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
training |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
regional area |
| 書誌情報 |
en : The Journal of Medical Investigation
巻 58,
号 1-2,
p. 81-85,
発行日 2011-02
|
| 収録物ID |
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|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
13496867 |
| 収録物ID |
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|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
13431420 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA11166929 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA12022913 |
| 出版者 |
|
|
出版者 |
Faculty of Medicine Tokushima University |
|
言語 |
en |
| EID |
|
|
識別子 |
233552 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
jmi_58_1-2_81.pdf (70.1 KB)
