The Clinical Trials Regulation (CTR) has added some complexities for non-EU sponsors, including with regard to the role of the legal representative. Sponsors who are not based in the EU must appoint a representative within the EU to act as a legal representative.
While this has always been a requirement, under the CTR the legal representative is responsible for “ensuring” the compliance of a non-EU sponsor.
As such, any legal rep will need time to properly evaluate this compliance. We have had existing and new clients urgently seeking help to start up their studies, but it’s important to allow time for the evaluation process.
It can be difficult to pinpoint the exact amount of time these processes would take, however, ideally, we would recommend between four and six months for a sponsor planning to start up a study to allow time for any issues with processing the work order and assessing the state of the QMS.
This allows time to get through the contract phase and to explain the role of the legal representative to clients. Following the contractual phase, the sponsor and IDEA will work together to complete the assessment of the sponsor’s compliance system. Once the compliance review is complete and we’re satisfied that the sponsor’s QMS complies with the scope set out in CTR, we will provide a declaration letter appointing us as legal representative. We may also assist clients to register for EudraVigilance.
Step-by-step evaluation process
Before we take on the legal rep role, we provide clients and prospective clients with a questionnaire for completion. We recommend they have a member of their quality team complete that, or, where that’s not possible, that it be completed by someone with an overall knowledge and understanding of the quality system, potentially with input from experts.
The questionnaire serves as a high-level overview of the quality management system (QMS), covering company information, quality procedures and processes, as well as standard operating procedures.
The questions are based on the requirements of the CTR and provide a light touch for sponsors to help them evaluate their own compliance. One US client recently said while there were initial concerns about the additional work in preparing the questionnaire, it served as a beneficial exercise for the quality team to have an ex-US set of eyes on their QMS – something they would otherwise not get without an audit.
Assessing the questionnaire
Once we receive the questionnaire, we assess it to ensure everything is consistent. We then discuss with the client any gaps, for example if procedures aren’t in place, or action areas. We also request finalised SOPs and then discuss what needs to be done to get the QMS to a point where we would be happy to take on the role of legal rep.
Taking the time to properly review the process is essential for the legal rep, who takes on that legal responsibility, but it is also an invaluable exercise for sponsors, since it can help to make the process more efficient and reduce the risk of issues with quality checks.
“The CTR necessitates allowing more time for the legal rep to properly evaluate compliance with the regulation.”