The Clinical Trials Regulation (EU) 536/2014 was implemented to harmonise the process of conducting and monitoring clinical trials across the European Union (EU) whilst simultaneously improving transparency. The December 2020 CTIS highlights newsletter covers the key features and future developments in the CTIS.
The proposed benefits of the CTIS revolve around it being the single EU entry point for clinical trial applications and safety reports, as well as providing a source of searchable clinical trial information for healthcare professionals, patients and the general public. As such the CTIS strives to improve the clinical trial process through:
- Digitalisation and improved efficiency
- Increased Transparency
- Enhanced patient safety
- Support to innovation and research
This newsletter highlights the features available to the Member State and Sponsor users of the CTIS. Feature availability is based on role classification, which is split into high-level administrators, medium-level administrators and business roles. In addition, Sponsors and Member States will be able to intact with each other using the CTIS. A dedicated “Sponsor Workspace” will provide a menu by which sponsors will be able to perform activities such as submitting an initial application and making any amendments. The “Authority Workspace” will enable Member States to review applications, request additional information and supervise approved ongoing trials. The European Medicines Agency (EMA) conducted a webinar on 21 September 2020 which covered these features in detail. A recording of the webinar can be found here.
The EMA highlights that an essential factor in the successful implementation of the CTIS is thorough training for all those who will use it. The newsletter details how online self-paced training resources will be available in 2021 for all user groups to ensure equal access for all. In addition to this, tailored training programmes will be used to disseminate information. The programmes are split into three “streams”:
- Training in the functionalities of the system for all CTIS roles available to sponsors. This training is intended for commercial Sponsors and Contract Research Organisations (CROs) that will submit several clinical trial applications.
- For small and medium-sized enterprises (SME) and non-commercial sponsors (such as academic sponsors), this stream will contain tailored and focussed training to suit their needs.
- For the end-users from all sponsor groups, this stream provides training in role-specific features (administrator, preparer, and submitter).
Despite the legislation being adopted in 2014, it does not come into force until the CTIS is fully developed and functional as determined by an independent audit. The newsletter concludes with updates on the audit and proposed future developments. The independent audit of the EU Portal and Database (EUPD) began in September 2020, with updates planned based on the findings of the audit. Further features will be introduced before and after the current proposed go-live date of December 2021.
To access the full newsletter, click here.