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Clinical Studies Using in Vivo Diagnostic Radiopharmaceuticals under the Clinical Research Law
https://repo.qst.go.jp/records/49318
https://repo.qst.go.jp/records/49318544316cb-4866-42a6-9c39-3fa2d8b474ce
| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2018-09-18 | |||||
| タイトル | ||||||
| タイトル | Clinical Studies Using in Vivo Diagnostic Radiopharmaceuticals under the Clinical Research Law | |||||
| 言語 | ||||||
| 言語 | eng | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
| 資源タイプ | journal article | |||||
| アクセス権 | ||||||
| アクセス権 | metadata only access | |||||
| アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
| 著者 |
Washino, Komei
× Washino, Komei× Ito, Natsue× Yoshinaga, Keiichiro× Washino, Komei× Ito, Natsue× Yoshinaga, Keiichiro |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | The Japanese Ministry of Health, Labour and Welfare (JMHLW) introduced the Clinical Research Law1 in April 2018. Clinical studies to evaluate pharmacokinetics or the efficacy or safety of in vivo diagnostic radiopharmaceuticals have to be conducted under either the Clinical Research Law or the Japanese Good Clinical Practice (GCP) guidelines. The Clinical Research Law provides stricter regulation than does the current Ethical Guideline for clinical studies, and it allows the regulatory authority to issue orders to suspend or change clinical studies. Given that a clinical study may require the same amount of time, human resources and funding resources no matter which regulatory scheme is followed, clinical investigators need to bear in mind the objectives and funding support for the planned study when choosing which legislation to adhere to. This article reviews various factors that may help determine which of the recently introduced pieces of legislation is applicable in the planning of a particular clinical study. We also aim to establish approaches to identify the appropriate law and to enable non-clinical studies to move forward to the clinical study phase. 1This review article was written before official release of the English translation of the Clinical Research Law in June 28 2018. Although the law is officially entitled the Clinical Trials Act in English, this review uses the terminology “the Clinical Research Law”. |
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| 書誌情報 |
Annals of Nuclear Cardiology 巻 4, 号 1, p. 88-93, 発行日 2018-08 |
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| 出版者 | ||||||
| 出版者 | Shunkosha Co.,Ltd | |||||
| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 2189-3926 | |||||
| DOI | ||||||
| 識別子タイプ | DOI | |||||
| 関連識別子 | 10.17996/anc.18-00083 | |||||
| 関連サイト | ||||||
| 識別子タイプ | URI | |||||
| 関連識別子 | https://www.jstage.jst.go.jp/article/anc/4/1/4_18-00083/_article/-char/en | |||||
