12/16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URLのウェブサイトをご
Clinical Trial Information System (CTIS) list values
Clinical Trial Information System (CTIS) structured data form - Request for information (RFI)
Clinical Trial Information System (CTIS) structured data form - Annual Safety Report (ASR)
Clinical Trial Information System (CTIS) structured data form - Notifications (updated)
Clinical Trial Information System (CTIS) structured data form - Multi trial substantial modification (updated)
Clinical Trials Information System: training and support (updated)
Instructor's guide: How to manage a CT - CTIS Training Programme - Module 05 (updated)
FAQs: How to manage a CT - CTIS Training Programme - Module 05 (updated)
Step-by-step guide: How to manage a CT - CTIS Training Programme - Module 05
Quick guide: How to manage a CT - CTIS Training Programme - Module 05
Clinical Trials Information System (CTIS): online modular training programme(updated)
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