November 2021: CTIS Webinar Update

EMA updated the Clinical Trials Information System (CTIS): Virtual information day event page by adding a list of documents, on November 11, 2021. The following documents (PowerPoint presentations) were presented by the speaker on the day of the event:

  1. CTIS The future user perspective: Welcome– It includes a brief introduction to CTIS, information on its workspace and public portal, its go-live timeline, purpose, and steps required for its preparation.
  2. CTR & CTIS: Key aspects for users to consider when preparing for CTIS– It includes milestones for clinical trial regulation 536/2014 (CTR), the process of CTR assessment, CTIS roles and actions, and CTIS high-level structure. It also includes information on a harmonised dossier, transparency in the CTR, and requirements for CTR submission.
  3. How to prepare for CTIS: a user perspective– It explains the process of registration, user management, an overview of CTIS user personas, notices, alerts, and requests for information (RFIs).
  4. How to access CTIS training materials and support– It provides links to all the CTIS training modules, sponsor handbook for clinical trial sponsors, reference material, and recording of previous events. It also presents the three phases of CTIS Sandbox.
  5. CTIS The future user perspective: Closing– It includes a diagrammatic representation for preparation of CTIS and the countdown for CTIS go-live.

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