November 2021: CTIS Webinar Update

EMA updated the Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) event page by adding a list of documents, on November 25, 2021.

The following documents are PowerPoint presentations that are to be presented in the Webinar that will be held on November 29, 2021:

  1. Clinical Trial Regulation 536/2014: Objectives, key changes, and transitional arrangements: It describes in detail the difference between the existing and upcoming legislative. It also explains the processes involved in clinical trial results (CTR) submission and authorization, the process of transition from the pre-clinical trial per Directive 2001/20/EC (CTD) to CTR, CTD to CTR, and submission of application of transition.
  2. European Organisation for Research and Treatment of Cancer (EORTC): Stakeholders’ experience with the Clinical Trial Regulation No. 536/2014 implementation: It explains the main points of impact highlighting the timelines for initial, substantial modification, a summary of CT results and results for layperson submissions, and updates in the study documentation (new harmonized CV template, protocol, informed consent form, lay summary for protocol and results). It also presents, in brief, the key compliance considerations, enlists different types of stakeholders, transparency rules, and user management approaches.
  3. Medical Faculty and Heidelberg University Hospital: Stakeholders’ experience with the Clinical Trial Regulation No. 536/2014 implementation: It provides the key points to remember for the user management, accessibility to CTIS, transition period, timelines, and processes.
  4. Transgene: Stakeholders’ experience with the Clinical Trial Regulation No. 536/2014 implementation: It provides a three-step approach for CTR implementation preparation i.e., identify, inform and prepare, and implement. It also confers some of the experienced comments and challenges faced in CTR adoption along with advices for CTR implementation and preparation.
  5.  Access and user management, roles, and permissions: It provides information on self-registration, default CTIS roles, different approaches of user management, pros and cons of organization-centric and clinical trial-centric approaches, roles and permissions required, and user management hierarchy.
  6. CTIS explained with user personas and organisation models: It describes the core personas of CTIS and organization modelling with its key principles.
  7. High-level overview of CTIS, joint controllership arrangement (JCA), and publication rules: It describes the high-level functionalities explaining the authority and sponsor workspaces, the open and secure accesses, and roles of sponsor and member states. It also explains the publication rules in CTIS, deferral eligibility for category 1 trials, data that will be published, and things that will not be made public regardless of its category.
  8. The process for submitting clinical trials information in the European Union-European Economic Area (EU-EEA): It provides timelines and due dates in CTIS, information on the required database before initial submission, submission of CTA, evaluation timeline, intended corrective measure timeline, substantial and non-substantial modifications, update for initial submission, application for re-submission, and trial and recruitment periods.
  9. Safety reporting in CTIS: It provides an overview of reporting safety data in CTIS and briefs the legal framework of Regulation (EU) 536/2014.
  10. Overview of guidance and training available for sponsors: It provides the CTIS catalog of all the training materials along with its current status. It also explains in short regarding the CTIS Sandbox.

A tab for live broadcast has already been uploaded by EMA on the event page. Video recording of the webinar will be made available after the event.

For more information, please click here.