March 2022: CTIS Highlights

The eighth issue of CTIS Highlights was published on March 25, 2022. It mentions with this edition CTIS Highlights have become Clinical Trials Highlights. It provides the key updates on clinical trials governance, discusses the communications for Clinical Trials Regulation and CTIS go-live, and enlists the upcoming events. It also briefly explains the protection of personal data (PD) and commercially confidential information in CTIS and notifies about the updates to be made in EMA Account Management.

It discusses the Accelerating Clinical Trials (ACT) that was launched on January 13, 2022, that works closely with the Clinical Trials Advisory Group (CTAG), and the newly established Clinical Trials Coordination Group (CTCG) and aims to transform the initiation, design, and run of clinical trials. It also provides brief information on CTAG, CTCG, and ACT EU Steering Group.

EMA continues to communicate with various audiences on different platforms. It also provides regular updates through CTIS newsflash which highlights the CTIS usage, provides tips for users, and useful reference materials. It also informs about the CTIS demonstration held on January 20, 2022, for sponsors to showcase system functionalities. It mentions EMA’s plans for further demonstrations in the second half of 2022.

It briefly discusses the upcoming events –

  • CTIS sponsor end-user program: Runs monthly until June 2022, places available for April, May, and June courses
  • CTIS bitesize talks: Runs monthly and allows sponsors to learn about a dedicated CTIS functionality via demonstration followed by a Q&A session. The next bitesize talk will be held on April 28, 2022
  • CTIS walk-in clinics: Runs twice a month and provides an opportunity for users to ask questions about any aspect of CTIS functionality. The next events will be held on April 04, 2022, and April 28, 2022, respectively

It informs that access to CTIS Sandbox has been provided to sponsors after Survey 1.0. Sponsors who did not respond to Survey 1.0 can respond to Survey 2.0 which includes a self-assessment of the need and urgency of access to the CTIS training environment. Survey 2.0 will close on March 31, 2022. It is advised that sponsors who already participated in Survey 1.0 not participate in Survey 1.0 unless there is a change in their clinical trials submission plans.

The newsletter also informs that EMA is preparing guidance on the protection of PD and CCI and the draft for consultation will be shared in Quarter 2 (Q2) of 2022. It also briefs about the new role of external organization administrators in the EMA Account Management that can approve or reject requests to become an administrator for EMA-run
systems for the organization.