論文

査読有り
2019年

Preparation of standard operating procedures reflected the latest information for investigator-initiated clinical trials

Japanese Pharmacology and Therapeutics
  • Hiroshi Hayashi
  • Koji Iwasaki
  • Izumi Kumagai
  • Saki Yokoshiki
  • Kayoko Kikuchi
  • Shinobu Shimizu
  • Mayumi Teramachi
  • Yuki Kagayama
  • Kotone Matsuyama
  • Hiroi Kasai
  • Makiko Uchiyama
  • Manabu Yamamoto
  • 全て表示

47
開始ページ
S134
終了ページ
S147
記述言語
掲載種別
研究論文(学術雑誌)

© 2019 Life Science Publishing Co. Ltd. All rights reserved. Objectives Standard Operating Procedure (SOP) is needed to conduct investigator-initiated clinical trials. SOP templates for drug and medical device have been released on website, however, preparation processes for SOP depends on the institutions conducting a clinical trial. Moreover, no templates for regenerative medicine products are released. Here we created of SOP templates for regenerative medicine products, and also revised SOPs for drugs and medical devices. Methods First, we searched the notifications and guidelines relating investigator-initiated clinical trials. Then SOP templates for drug and medical device were updated to reflect the latest notifications and guidelines as of the end of March 2019. Then, based on them, SOP templates of regenerative medicine products were made. Results The drug and medical device SOP templates were updated according to the 18 notifications and 7 guidelines from December 2012 to March 2019, and a regenerative medicine product SOP templates were newly created according to the latest notifications and guidelines as of the end of March 2019. Conclusions The SOP templates for drugs, medical devices and regenerative medicine products were created and released on the JMACCT website. They can be browsed and used by clinical trial personnel. These SOP templates can also be used as an education and training.material. We hope that the proper use of these templates will help reduce or prevent deviations from GCP and regulations, and help achieve the quality control goals.

リンク情報
Scopus
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85078096792&origin=inward
Scopus Citedby
https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85078096792&origin=inward
ID情報
  • ISSN : 0386-3603
  • SCOPUS ID : 85078096792

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