December 2021: CTIS Highlights

The sixth issue of CTIS Highlights was published on December 13, 2021. It provides certain preparatory steps to be taken by the sponsor before using CTIS, discusses the upcoming events and training material to be updated in early 2022.

It reminds all future CTIS users without an EMA account to register for an EMA account as soon as possible. It also reminds the sponsor organizations opting for the organization-centric approach to register in EMA’s organization management system (OMS) along with their first high-level administrator, the sponsor administrator, via EMA account management before using CTIS, if not registered yet. The clinical trial sites that routinely participate in clinical trials are advised to register in OMS to facilitate submission of clinical trial application (CTA).

It briefly discusses EMA’s plan to host ‘CTIS Talks’, an upcoming event explaining CTIS key functionality areas. In this event, participants will get an opportunity to ask questions to CTIS experts. More details about the event will be provided shortly.

The newsletter also notifies that along with the 20 CTIS training modules that are currently available, revisions of the existing modules and new modules including introduction to CTIS for public users, management of union controls by European Commission, and transition of clinical trials from directive to regulation will be published in the upcoming year of 2022.

It mentions that the respondents of the survey provided in the previously issued newsletter regarding self-assessment and interest in accessing the training environment will be contacted directly in December 2021. It also discusses, in brief, the sponsor end-user training that will start next year and the recently updated version of the CTIS Sponsor Handbook.