The Clinical Trial Regulation (CTR) replaced the Clinical Trial Directive (CTD) on 31 January 2022. By 31 January 2025, all EU clinical trials must comply with the Clinical Trial Regulation (CTR). This regulation harmonises the submission, assessment, and supervision of EU clinical trials facilitated through the Clinical Trials Information System (CTIS). CTIS is the single-point entry system for exchanging all trial-related information, documentation, and communication between member states and clinical trial sponsors.
The EU Clinical Trials Regulation (CTR) entered into force on 31 January 2022 and became mandatory for all new applications from 31 January 2023.
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Contact UsTake a look at how we have helped some of our clients with the Clinical Trials Regulation.
The client had an ongoing study that required a transition submission (from EU CTD to EU CTR). Two non-IMPs were in the study under CTD, and according to the CTR requirement, both drugs were required to be registered as auxiliary IMPs (AxMPs) in the transition application. Additional CMC, reference safety documents, and labels were required for the CTR submission.
DLRC provided guidance about the CTR requirements regarding AxMPs and coordinated and led discussions with the client subject matter experts (including medical, safety, and drug supply experts) to obtain all necessary documents for submission.
The transition application was approved by all Member States Concerned (MSC) and by the Reporting Member State (RMS) without any questions regarding AxMPs.
A client needed CTR expertise to assess current procedures and processes. They required expert guidance to develop a CTR implementation roadmap.
DLRC assessed the client’s SOPs and current processes and completed a gap analysis for CTR compliance. DLRC ran workshops with the client to enhance their understanding of the CTR and drive implementation strategy and planning recommendations.
The client’s SVPs of Clinical Operations and Regulatory Affairs endorsed the implementation roadmap. With their vastly increased knowledge and understanding of the CTR, the client team was confident that they could fully implement the necessary changes to operate effectively and compliantly under the CTR.
A client sought CTR subject matter expertise from DLRC to augment their existing CTR implementation team and support with training and operational process development.
DLRC experts were integrated into the client’s existing CTR implementation team. We provided advice and recommendations for operating effectively under the CTR. DLRC acted as the client team’s primary contact point for CTR-related queries, supporting them in further developing their understanding.
The increased knowledge and understanding gained from DLRC’s support enabled the client team to manage their CTR compliance independently. We assessed the options for operating effectively under the CTR and made the necessary adjustments to their current operating model. One of the adjustments made was to involve their US-based team as part of a transparency integration across their organisation.
A client intended to conduct a clinical trial in the EU; however, they were not set up on any of the EU systems required to enable the submission of a CTA via CTIS.
DLRC guided the client on the EU systems. They required registration and CTIS access, and the DLRC team helped them obtain the relevant information and registration/access as required at each step. Once the client had access, the DLRC team also guided the management and allocation of the relevant roles within CTIS.
Whilst often overlooked, correct system registration and access are critical to CTA submission in the EU. With DLRC’s support, the client completed the CTA submission according to their planned timeline without delays.
The client had submitted their initial CTA in the EU for their clinical trial. During the review, the client realised that additional informed consent forms (ICFs) needed to be submitted and approved before the trial could start, which had not been included in the initial CTA dossier.
DLRC negotiated with the Member States concerned on behalf of the client to allow for the additional ICFs to be included within the initial procedure, thereby avoiding the need for submission of a substantial modification after the initial approval of the CTA to include these documents.
As the need for submission of a substantial modification was avoided, the client was able to start the clinical trial in the EU as per their planned timelines with no delays incurred.
