《更新》EMA／Clinical Trials Information System (CTIS) 関連情報（2024年6月18日付）

※初出掲載 （2024.06.18）
※追記更新 （2024.06.19）（2024.06.21）

6/18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。

今回は、以下のものです。
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参照ください。

• 「Faster access to clinical trial information in Europe」～CTISの改訂版です
  https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europe
• 「Clinical Trials Information System」
  https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system
• 「Development of the Clinical Trials Information System」
  https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system/development-clinical-trials-information-system
• 「Clinical Trials Information System: training and support」
  https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-training-support
• 「Clinical Trial Information System (CTIS) structured data form - Multi trial substantial modification」
  https://www.ema.europa.eu/en/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-multi-trial-substantial-modification_en.xlsx
• 「Clinical Trial Information System (CTIS) structured data form - Request for information (RFI)」
  https://www.ema.europa.eu/en/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-request-information-rfi_en.xlsx
• 「Clinical Trial Information System (CTIS) structured data form - Notifications and results」
  https://www.ema.europa.eu/en/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-notifications-results_en.xlsx
• 「Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification」
  https://www.ema.europa.eu/en/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-initial-application-additional-member-state-concerned-substantial-modification-non-substantial-modification_en.xlsx

【6/19付追記更新】
6/18付で上記に加え、多数のCTIS関係通知が発出されています。
関係者および興味のある方は、下記URLの通知等をご参照ください。

• 「Clinical Trials Information System (CTIS) common features - CTIS Training Programme - Module 02」
  https://www.ema.europa.eu/en/documents/other/clinical-trials-information-system-ctis-common-features-ctis-training-programme-module-02_en.pdf
• 「Roles and permissions matrix summary - Authority workspace - CTIS Training Programme - Module 07」
  https://www.ema.europa.eu/en/documents/other/roles-permissions-matrix-summary-authority-workspace-ctis-training-programme-module-07_en.pdf
• 「Step-by-step guide : Create, submit and withdraw a clinical trial application and nonsubstantial modifications - CTIS Training Programme - Module 10」
  https://www.ema.europa.eu/en/documents/other/step-step-guide-create-submit-withdraw-clinical-trial-application-nonsubstantial-modifications-ctis-training-programme-module-10_en.pdf
• 「FAQs: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10」～接続が？です
  https://www.ema.europa.eu/en/documents/other/faqs-how-create-submit-withdraw-clinical-trial-application-ctis-training-programme-module-10_en.pdf
• 「Checklist of required fields per application type - CTIS Training Programme - Module 10」
  https://www.ema.europa.eu/en/documents/other/checklist-required-fields-application-type-ctis-training-programme-module-10_en.pdf
• 「Step-by-step guide: How to respond to requests for information received during the evaluation of a Clinical Trial Application - CTIS Training Programme - Module 11」
  https://www.ema.europa.eu/en/documents/other/step-step-guide-how-respond-requests-information-received-during-evaluation-clinical-trial-application-ctis-training-programme-module-11_en.pdf

【6/21付追記更新】
6/20付のRAPSがEuro Roundup内に「EMA updates transparency rules, removing mechanism that delayed clinical data publication」と題して、上記のうちの「Faster access to clinical trial information in Europe」について記事に取り上げています。

関係者および興味のある方は、下記URLのニュース記事をご参照ください。
https://www.raps.org/News-and-Articles/News-Articles/2024/6/Euro-Roundup-Commission-publishes-HTA-guidance-on