The implementation of the Clinical Trials Regulation (CTR) has introduced additional complexities for non-EU sponsors, particularly concerning the obligations of the legal representative. Non-EU sponsors are mandated to appoint an EU-based legal representative to ensure compliance with CTR standards.
While the requirement for a legal representative is not new, the CTR explicitly tasks them with the responsibility of “ensuring” the compliance of non-EU sponsors. Therefore, it is crucial that legal representatives are allotted adequate time to thoroughly evaluate compliance. Although we’ve observed urgency among both new and existing clients seeking to initiate their studies, it is imperative to reserve sufficient time for the evaluation process.
Determining the precise duration for these processes can be challenging; however, we advise sponsors planning to commence a study to allow approximately four to six months. This timeframe accommodates potential delays in processing work orders and assessing the state of the Quality Management System (QMS).
This period allows for the completion of the contractual phase and provides an opportunity to elucidate the legal representative’s role to clients. Post-contract, the sponsor and IDEA collaborate to evaluate the sponsor’s compliance system. Upon satisfactory completion of the compliance review, and confirmation that the sponsor’s QMS aligns with the CTR scope, we issue a declaration letter, appointing ourselves as the legal representative. We may also assist clients with EudraVigilance registration.
Step-by-Step Evaluation Process
Before assuming the role of a legal representative, we provide both current and potential clients with a detailed questionnaire. We recommend a member of the client’s quality team complete it or, if unavailable, an individual with a comprehensive understanding of the quality system, potentially supplemented by expert insights.
The questionnaire provides a high-level overview of the QMS, encompassing company information, quality procedures, processes, and standard operating procedures. Designed in accordance with CTR requirements, it offers sponsors a preliminary tool to evaluate their compliance. A recent example from a US client highlighted that, despite initial reservations about the additional workload, the questionnaire proved beneficial, offering an external perspective on their QMS—a rare opportunity without an audit.
Evaluating the Questionnaire
Upon receiving the questionnaire, we conduct a thorough assessment to verify consistency and identify any gaps, such as missing procedures or necessary action areas. We request finalized Standard Operating Procedures (SOPs) and discuss what adjustments are needed to elevate the QMS to a level where we can confidently undertake the legal representative role.
Dedicating time to this meticulous review is not only essential for the legal representative, who bears legal responsibility but also serves as a valuable exercise for sponsors. It can streamline the process and minimize risks associated with quality checks.
“The CTR necessitates allowing more time for the legal representative to properly evaluate compliance with the regulation.”
