How long does it take to prepare the full documentation required for a CTIS submission?
Preparing a complete documentation package for submission of a clinical trial in the CTIS system is a multi-stage process that in practice takes from several weeks to even several months. Although the assessment timelines are clearly defined under EU Regulation 536/2014, the actual time needed to prepare a complete application largely depends on the complexity of the study, the readiness of source documents, and the experience of the project team.
In a typical scenario, for a study of moderate complexity, preparation of the full documentation takes on average between 12 weeks and up to 6 months. This includes not only compiling all required files, but also ensuring their consistency, adapting them to CTIS requirements, and preparing them for assessment by the competent authorities and ethics committees operating within the system coordinated by the European Medicines Agency (EMA).
The most time-consuming stages usually involve finalizing the protocol, preparing the IB or IMPD, safety documentation, informed consent forms, and national documentation (Part II), which must reflect local requirements. An additional challenge is that CTIS requires a high level of consistency across all sections—discrepancies that might previously have gone unnoticed often now result in validation questions at an early stage.
Preparation time increases significantly in the case of studies involving a new Investigational Medicinal Product (IMP), pediatric trials, multinational studies, or projects requiring extensive alignment between the sponsor, CRO, and study sites. In such cases, the preparatory phase may take 3–9 months, particularly if documents are developed sequentially rather than in parallel.
From a project management perspective, it is crucial to understand that the greatest delays do not stem from CTIS itself, but from insufficient preparation of documentation prior to submission. Gaps, inconsistencies, or unclear wording lead to validation questions and extend the time to approval. Each additional round of responses results in a tangible delay of First Patient In (FPI) and increased operational costs.
For this reason, more and more sponsors treat the documentation preparation phase as a strategic stage of the project rather than a formal obligation. A well-planned process, clear allocation of responsibilities, and an experienced team familiar with CTIS can significantly shorten preparation time, reduce the risk of questions, and ensure a smooth transition to the assessment phase. This ultimately translates into a faster study start, greater timeline predictability, and a real competitive advantage.
If you are aiming for an efficient and predictable regulatory process, we invite you to contact us. Based on our experience in managing clinical trials, we can help plan the process in a way that minimizes the risk of delays at the application assessment stage.
