October 2022: Clinical Trials Highlights

The eleventh issue of the Clinical Trials Highlights was published on October 21, 2022. Below are the key updates:

  • Over 100 clinical trials have now been authorized by the Clinical Trials Information System (CTIS)
  • Updated guidanceĀ on the protection of personal data and commercially confidential information (CCI) in CTIS will be provided in future issues considering the feedback received during the workshop and the 5-month public consultation period that concluded on 8 September 2022.
  • The CTIS Forum including CTIS users and experts from Member States, EU sponsors (Academia, Industry), Clinical Research Organisations (CROs), patients, and from healthcare professionals will meet quarterly to discuss the CTIS functionalities, system use, and development, as well as user support and knowledge acquisition.
  • EMA is currently reviewing all the responses received during Survey 3.0 for CTIS Sandbox and will provide eligible participants with access to CTIS Training Environment by the end of October 2022. The web address to CTIS Training Environment has also changed and users have been provided with the new web address through the e-mail account.
  • After October 18, 2022, administrators will have to indicate both the user ID and the email address of the user to assign roles to users in their organizations in CTIS.

To know more about the upcoming CTIS events like CTIS walk-in clinics, organization management service (OMS) troubleshooting sessions, CTIS Webinar – 9 months on and going forward, bitesize talks and sponsor end-user training programs that will be held in November and December 2022, please click here.