On the 31st of January, 2022, the European Commission’s new clinical trial legislation will come into effect. With the hope of creating a better environment to conduct clinical trials within the EU, the European Clinical Trials Regulation (EU CTR 536/2014) creates a uniform standard that all future trials will need to adhere to when conducting trials for medicinal products for human use.
The EU CTR aims to create harmony between member states, facilitate easier cooperation between member states and sponsors within clinical trials, improve safety standards, improve transparency to the public and harmonize submission and assessment processes between member states.
Clinical Trials in Europe: Directive Vs. Regulation
Before 2004, the processes and requirements for clinical trials were the responsibility of the individual EU member state and therefore varied from country to country. The introduction of the Clinical Trials Directive in May 2004 meant that requirements and processes of clinical trials were a step closer to harmonization, as a European directive sets objectives that EU member states must reach and incorporate into their national laws.
However, things were still variable from country to country, with separate clinical trial applications needing to be submitted to each country. The EU CTR has taken things a step further, not just by changing from a directive to a directly binding regulation, but also by creating a single-entry point for all European clinical trials via the Clinical Trial Information System (CTIS). The EU CTR and this portal go live on the 31st of January, with clinical trials now being registered via the system, simplifying applications, and publicly making data available.
Read more about the impact of EU CTR and CTIS in this blog by Deloitte.
User Management in CTIS
CTIS introduces a single entry portal for all clinical trials across Europe. Organizations must submit all documentation into the system, creating the need for the system to be used correctly.
Both employees of commercial and non-commercial sponsors can be provided access to the information in CTIS in various roles, meaning that proper user management is essential, and each user should be provided the correct level of access for their role within the trial.
All activities within CTIS will be affected by the changes to user management within the portal. It is a large part of EU CTR compliance, and organizations must prepare appropriately, including how submissions are prepared, which roles are involved and who will be the person clicking the “Submit” button, and the end of the process. As part of the preparation, organizations should also decide which role and with that, which employee(s) will be responsible for responding to RFIs in the CTIS system, which can be issued by the authorities and ethics committees in the assessment process and during the trial.
In this article from Deloitte, the impact and changes to user management are discussed in depth.
Major Changes to Submissions
While EU CTR does facilitate a more straightforward assessment procedure through the introduction of CTIS, organizations need to be aware of some new considerations. Timelines are stricter, there are no parallel submissions, and responses to requests for information (RFI) have changed.
These things must be taken into consideration after the 31st of January to ensure a smooth transition to the new system. Delays in processing and modifying submissions ultimately mean delays in starting and conducting trials, so it is vital to know what has changed with the implementation of EU CTR. During the transition period, starting January 31st 2022, submissions can still be done in accordance with the ‘old’ Directive and national laws, though such a decision will impact the course of the trial when the end date is after Jan 31st2025. At this date, all trials that were managed under the Directive will have to be transitioned to the EU CTR.
Become EU CTR ready with GCP Central.
While the 31st of January is looming, it’s simple for you and your team to be EU CTR ready. GCP Central’s diverse range of training solutions means that your company can start the new year ready to start new trials, compliant, and up to date. Our trainings are role-based, making training effective for the learners and cost-efficient for your organisation.
Online, interactive modules that can be completed on the go put training into your team’s pocket, along with a convenient dashboard to track their progress makes staying compliant easier.
Your team can learn everything they need to know to understand the basics of EU CTR and be ready for the changes this year. It is time to get EU CTR ready, and GCP Central can help you get there.
Ready to start? Choose the course that suits you here, or get in touch for a quote for your team. You’ll also find us at the 6th Annual European Conference on Clinical Research (EUCROF) on February 7 & 8, both in person and virtually. Please drop by our stand, or book a meeting with Marieke Meulemans to discuss your training needs.
Let us help you and your team be EU CTR ready.
