To successfully transition clinical trials to the EU Clinical Trials Information System (CTIS) from those previously approved under the EU Clinical Trials Directive, sponsors must undertake several essential preparatory measures. These preparatory steps can be extensive and often misunderstood, underscoring the necessity for thorough preparation.
Initial Preparations
Begin by ensuring that you have a statement verifying that all documents being submitted have undergone approval by both an ethics committee and competent authorities prior to their transition into CTIS. Additionally, a General Data Protection Regulation (GDPR) statement is required to affirm that all data has been gathered and processed in compliance with privacy laws.
A crucial new requirement mandates that the legal representative verifies the sponsor’s adherence to the regulations. This entails reviewing the sponsor’s quality management system to confirm the presence of sufficient resources and processes to meet regulatory compliance. This verification process must be completed prior to the sponsor’s registration in CTIS.
Furthermore, either you or your designated administrator must complete system training. The European Medicines Agency (EMA) provides a variety of online training modules for CTIS users, which should be carefully reviewed. Completing a Transitional Trials application form along with a detailed cover letter is also necessary.
Post-Transition Requirements
After the transition, sponsors will encounter several critical differences. Primarily, all notifications will now be routed through CTIS, replacing the previous methods of letters or emails used under the Clinical Trial Directive. Thus, it is imperative to familiarize yourself with CTIS or ensure robust communication channels with your Contract Research Organization (CRO).
Specific requirements regarding safety reporting and archiving must also be met. An annual safety report (ASR) must be submitted to a designated section of CTIS, detailing the ongoing safety profile of the Investigational Medicinal Product and any measures taken to mitigate potential risks.
Response times for Requests for Information (RFIs) concerning ASRs have also been tightened. While the standard response time is 14 days, the safety assessing Member State holds the authority to adjust this timeframe before issuing an RFI.
Strategic Submission Planning
Effective CTIS processes necessitate meticulous planning and resource allocation. Given the absence of parallel submissions, it is crucial to coordinate your data and document submissions carefully.
Consider the resources needed to maintain registrations and systems, the time required to renew or amend contracts with CROs, and the responsibilities that may be delegated to the CRO for the transition to and maintenance of CTIS. Importantly, despite any delegation to your CRO, the responsibility for the clinical study remains with you, the sponsor. Regulatory authorities require that you, as the sponsor, maintain a compliant Quality Management System (QMS).
Advantages of the Clinical Trials Regulation (CTR)
Although the transition to CTR and CTIS demands considerable time and resource investment, the benefits are significant. Notably, in the future, a single submission will suffice for all EU and European Economic Area (EEA) countries, streamlining the process. It is remarkable that 30 countries across Europe have reached a consensus on the CTR, demonstrating a unified approach.
In conclusion, strategic preparation and adherence to regulatory requirements are key to a successful transition to CTIS, ultimately facilitating more efficient clinical trial management across Europe.
