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著作: [楊河 宏章]/[苛原 稔]/Houchi Hitoshi/Kakehi Yoshiyuki/Moritoyo Takashi/Nomoto Masahiro/Miyamura Mitsuhiko/Shuin Taro/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./[The Journal of Medical Investigation : JMI]

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EID
233552
EOID
907239
Map
0
LastModified
2018年5月23日(水) 17:08:05
Operator
[ADMIN]
Avail
TRUE
Censor
0
Owner
楊河 宏章
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種別 必須 学術論文(審査論文)
言語 必須 英語
招待 推奨
審査 推奨
カテゴリ 推奨
共著種別 推奨
学究種別 推奨
組織 推奨
著者 必須
  1. 楊河 宏章([徳島大学.病院.中央診療施設等.総合臨床研究センター])
    役割 任意
    貢献度 任意
    学籍番号 推奨
  2. 苛原 稔([徳島大学.大学院医歯薬学研究部.医学域.医科学部門.外科系.産科婦人科学])
    役割 任意
    貢献度 任意
    学籍番号 推奨
  3. (英) Houchi Hitoshi
    データベース中に適合する可能性のある以下の情報を発見しました
    [個人] 芳地 一
    この情報が上記に掲げた個人の業績等に分類されるためには参照登録が必要です.上記に掲げた個人本人に該当する場合には参照登録に変更してください.
    役割 任意
    貢献度 任意
    学籍番号 推奨
  4. (英) Kakehi Yoshiyuki
    役割 任意
    貢献度 任意
    学籍番号 推奨
  5. (英) Moritoyo Takashi
    役割 任意
    貢献度 任意
    学籍番号 推奨
  6. (英) Nomoto Masahiro
    役割 任意
    貢献度 任意
    学籍番号 推奨
  7. (英) Miyamura Mitsuhiko
    役割 任意
    貢献度 任意
    学籍番号 推奨
  8. (英) Shuin Taro
    役割 任意
    貢献度 任意
    学籍番号 推奨
題名 必須

(英) 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.

副題 任意
要約 任意

(英) 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.

キーワード 推奨
  1. (英) Clinical Protocols
  2. (英) Clinical Trials as Topic
  3. (英) Cooperative Behavior
  4. (英) Drug Approval
  5. (英) Drug Discovery
  6. (英) Health Personnel
  7. (英) Humans
  8. 日本(Japan)
  9. (英) Questionnaires
発行所 推奨
誌名 必須 The Journal of Medical Investigation : JMI([徳島大学.医学部])
(pISSN: 1343-1420, eISSN: 1349-6867)
ISSN 任意 1349-6867
ISSN: 1343-1420 (pISSN: 1343-1420, eISSN: 1349-6867)
Title: The journal of medical investigation : JMI
Title(ISO): J. Med. Invest.
Supplier: 徳島大学
Publisher: Tokushima Daigaku Igakubu
 (NLM Catalog  (Webcat Plus  (医中誌Web  (J-STAGE  (CrossRef (Scopus information is found. [need login])
必須 58
必須 1-2
必須 81 85
都市 任意
年月日 必須 2011年 2月 初日
URL 任意
DOI 任意 10.2152/jmi.58.81    (→Scopusで検索)
PMID 任意 21372491    (→Scopusで検索)
NAID 任意
WOS 任意
Scopus 任意
機関リポジトリ 111305
評価値 任意
被引用数 任意
指導教員 推奨
備考 任意
  1. (英) Article.Affiliation: Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.

  2. (英) Article.PublicationTypeList.PublicationType: Journal Article