EMA/Clinical Trials Information System (CTIS) 関連情報(2021年7月6日付)

7/6付でEMAから「Clinical Trials Information System (CTIS) 関連情報」の通知が発出されています。

GCP関係者及び興味のある方は、下記URLsのウェブサイトをご参照ください。

●  7/6付Updated「Clinical Trials Information System (CTIS): training programme
https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation/clinical-trials-information-system-ctis-training-programme

●  7/6付「Quick guide: How to search, view and download a Clinical Trial and a Clinical Trial Application - CTIS Training Programme - Module 15
https://www.ema.europa.eu/en/documents/other/quick-guide-how-search-view-download-clinical-trial-clinical-trial-application-ctis-training_en-0.pdf

●  7/6付「FAQ: How to search, view and download a Clinical Trial and a Clinical Trial Application - CTIS Training Programme - Module 15
https://www.ema.europa.eu/en/documents/other/faq-how-search-view-download-clinical-trial-clinical-trial-application-ctis-training-programme_en.pdf

●  7/6付「Instructor's guide: How to search, view and download a Clinical Trial and a Clinical Trial Application - CTIS Training Programme - Module 15
https://www.ema.europa.eu/en/documents/other/instructors-guide-how-search-view-download-clinical-trial-clinical-trial-application-ctis-training_en-0.pdf

●  7/6付「Step-by-step guide: How to search, view and download a Clinical Trial and a Clinical Trial Application - CTIS Training Programme - Module 15
https://www.ema.europa.eu/en/documents/other/step-step-guide-how-search-view-download-clinical-trial-clinical-trial-application-ctis-training_en.pdf

●  7/6付「FAQs: Supervise a Clinical Trial and a Clinical Trial: Inspection records - CTIS Training Programme - Module 16
https://www.ema.europa.eu/en/documents/other/faqs-supervise-clinical-trial-clinical-trial-inspection-records-ctis-training-programme-module-16_en.pdf

●  7/6付「Step-by-step guide: Supervise a Clinical Trial and a Clinical Trial: Inspection records - CTIS Training Programme - Module 16
https://www.ema.europa.eu/en/documents/other/step-step-guide-supervise-clinical-trial-clinical-trial-inspection-records-ctis-training-programme_en.pdf

●  7/6付「Process puzzle exercise : Supervise a Clinical Trial and a Clinical Trial: Inspection records - CTIS Training Programme - Module 16
https://www.ema.europa.eu/documents/other/process-puzzle-exercise-supervise-clinical-trial-clinical-trial-inspection-records-ctis-training_en.pptx

●  7/6付「Instructor's guide: Supervise a Clinical Trial and a Clinical Trial: Inspection records - CTIS Training Programme - Module 16
https://www.ema.europa.eu/en/documents/other/instructors-guide-supervise-clinical-trial-clinical-trial-inspection-records-ctis-training-programme_en.pdf

●  7/6付Updated「Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS , Virtual meeting, from 29/07/2021 to 29/07/2021
https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-webinar-how-sponsor-organisations-can-prepare-ctis

●  7/6付「Agenda - Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS
https://www.ema.europa.eu/en/documents/agenda/agenda-clinical-trials-information-system-ctis-webinar-how-sponsor-organisations-can-prepare-ctis_en.pdf

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