European Medicines Agency published the fifth Clinical Trials Information System (CTIS) newsflash over the What’s New Section on March 08, 2022:
This newsletter reports the key metrics for the period February 21, 2022, to February 27, 2022, including the total number of logins to CTIS, number of draft applications in CTIS, and number of submitted applications in CTIS. The spotlight of this newsletter updates that three submitted clinical trials have passed validation by relevant regulatory authorities. It explains in brief about validation during the evaluation of the clinical trial application.
It informs users to indicate if the clinical trial that is being submitted to CTIS is a transition trial from Clinical Trials Directive to Clinical Trials Regulation. It also provides steps to indicate a transition study while creating an initial clinical trial application. It informs that users can link the EudraCT number to the trial with the help of a new field in the ‘Form’ section which is enabled by clicking ‘Transition trial’. If users do not select the checkbox at the time of the creation of the initial application, they need to cancel the clinical trial application and create a new one.
It further updates about the two upcoming industry webinars:
- Introduction to Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities
- Requesting access to and using EMA’s substance product, organisation and referential (SPOR) application programming interface (API)
These webinars will be held on March 10, 2022 and March 18, 2022, respectively. Video recordings for these will be provided after each webinar.
CTIS also updates about the regular and ad-hoc maintenance periods on which the system will be intermittently unavailable for users:
- Each Tuesday: 18:00 – 21:00 (Amsterdam time)
- Each Thursday: 18:00 – 21:00 (Amsterdam time)
- Each first Saturday of the month, starting in March, from 10:00 – 14:00 (Amsterdam time)
EMA advises users to review Module 06 – Evaluate a clinical trial application: Selection of RMS and validation of a clinical trial application and Module 23- Transition trials for get more information on validation of clinical trials in CTIS and transitioning trials.
For more information, please click here.