European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme, on December 14, 2021, by adding the new versions of the below documents:
- Step-by-step guide: Create, submit and withdraw a clinical trial application and nonsubstantial modifications – Module 10: It explains the different types of clinical trial applications (CTA), non-substantial modifications and steps required for creating, submitting and withdrawing it.
- Step-by-step guide: How to respond to requests for information received during the evaluation of a Clinical Trial Application – Module 11: It provides stepwise guidance for sponsor users to view and access right for information (RFI) raised by member states concerned (MSC) and to create, modify an existing CTA and submit a response.
- FAQs: Union Controls in CTIS – Module 21: It provides answers to general questions regarding Union Controls, its reports, plans/programmes, roles and permission.
- Step-by-step guide: Union Controls in CTIS – Module 21: It provides stepwise guidance to create and share plans/programmes for Union Controls and also to create, submit, view, download, update and withdraw Union Control reports.
- Quick guide: Introduction to CTIS for public users – Module 22: It provides an overview of the CTIS public website and stepwise guidance for public users to search, view, and download information of a clinical trial (CT). It also provides steps to view the Union Control reports.
- FAQs: Introduction to CTIS for public users – Module 22: It provides answers to questions regarding CTIS public website, its different search functionalities, view and download CTs and CTAs information, and Union Controls.
Also, an updated version of the Guide to CTIS training material catalogue was uploaded with the addition of ‘Module 24: Business Intelligence Reporting’ in the list of modules and general CTIS information.