May 2022: Clinical Trials Highlights

The ninth issue of Clinical Trials Highlights was published on May 25, 2022. It discusses the priorities and key aspects of accelerating clinical trials (ACT EU). It informs that a Q&A on complex clinical trials covering topics related to planning and conducting clinical trials and, designing and conducting master protocols will be provided soon.

It explains key performance indicators (KPIs) that are used to measure the number of clinical trial applications submitted in the Clinical Trials Directive (CTD) and Clinical Trials Regulation (CTR) since January 31, 2022. KPIs include metrics of authorized clinical trials that are mono-national and multi-national, commercial and non-commercial, and trials as per trial phase and therapeutic area. It informs that starting from May 2022 these KPIs will be provided every month.

It also explains to sponsors how to respond to requests for information (RFIs) with screenshots. A draft guidance document on the protection of PPD and CCI has been made available by the EMA and is open for consultations until September 08, 2022. It reminds users that the due dates in CTIS expire at Central European Time (CET) midnight. It also informs that in May 2022, updated documents in Module 03 – User Access Management has been published over the CTIS: online modular training programme.

It briefly discusses the upcoming events –

  • June 20 to June 23, 2022: Sixth edition of the sponsor end-user training program that guides users to submit clinical trial applications and manage the life cycle of clinical trials in CTIS
  • May 31, 2022, and June 23, 2022: CTIS bitesize talks allow sponsors to learn a dedicated CTIS functionality via demonstration followed by a Q&A session.

Along with the above events, the CTIS information event will be held to discuss the lessons learned in the first six months from the launch of CTIS, and CTIS walk-in clinics that are conducted twice a month for users to receive advice from CTIS experts. EMA informs that starting from June 2022, it will conduct monthly sessions for addressing questions by sponsors and clinical trial sites as part of a follow-up on the OMS Industry training webinar. It also provides a link for the latest version of possible workarounds, known issues, website outages, and system releases of the CTIS.