September 2021: CTIS Training Updates

European Medicines Agency updated the page name of Clinical Trials Information System: training programme to Clinical trials information system (CTIS): online modular training programme, on September 03, 2021. The below documents were also updated in CTIS Training Module 03 (User access management) and new versions of documents were added in Module 19 (CTIS for SMEs and academia):

  1. FAQs (v1.2): User access management – Module 03: It includes questions related to the processes of self-registration, login to CTIS, basic roles and permissions in CTIS, and user profile management with answers and diagrams.
  2. Quick guide (v1.2): User access management – Module 03: It guides on the process of self-registration, steps to log in to CTIS, understand the roles and permission and in brief about user profile management.
  3. Step-by-step guide 1 (v1.0): User access management and user administration- Module 19: It provides step by step guide for registration on CTIS, viewing roles and managing user profiles. It also explains briefly about CT-centric and Organisation-centric approaches, respectively.
  4. Step-by-step guide 2 (v1.0): CTIS workload functionalities for the sponsor workspace – Module 19: It provides step-by-step guidance on how to use the workload functionalities- notices and alert tab, request for information (RFI) list tab and timetable tab along with screenshots for every step.
  5. Step-by-step guide 3 (v1.0): Search, view and download a CT and a CTA in the sponsor workspace – Module 19: It provides steps for searching, viewing, and downloading CT and/or CTA along with detailed screenshots.
  6. Step-by-step guide 4 (v1.0): Create, submit and withdraw a clinical trial application and nonsubstantial modifications – CTIS Training Programme – Module 19: It provides steps to create and submit different types of CTs (mono-national and multi-national) with screenshots for better understanding.
  7. Step-by-step guide 5 (v1.0): Create and submit an RFI response, including changes to an existing application – CTIS Training Programme – Module 19 It provides steps to view and access RFIs raised by the Member States Concerned (MSCs) during the validation and assessment phases of the evaluation of a CTA, as well as on how to create and submit the responses, and how to modify an existing CTA as part of the response.
  8. Step-by-step guide 6 (v1.0): How to manage a clinical trial – CTIS Training Programme – Module 19 It provides steps for creating different types of notification, responds to RFIs in context with ad hoc assessment, request for corrective measures and steps to submit trial results and lay summary of results.
  9. Step-by-step guide 7 (v1.0): Submit an Annual Safety Report (ASR) and how to respond to related RFIs – Module 19 It provides steps to create and submit ASR submission form, access and respond to RFIs in the context of ASR assessment.