Where and how to register clinical trials, medical device studies, and observational studies?
Registration of studies in public information systems has become a standard in conducting research projects and an important element of scientific transparency. This applies not only to traditional clinical trials of medicinal products, but also to medical device studies and observational research, including Real World Evidence projects. In practice, sponsors often wonder which systems should be used for registration and whether this process can be delegated to a CRO partner.
The choice of the appropriate registry depends primarily on the type of study and the status of the investigated product. In the case of clinical trials of medicinal products conducted in the European Union, a key role is played by the Clinical Trials Information System (CTIS), operating under Regulation (EU) No 536/2014. This system enables the submission of regulatory applications and the public disclosure of study information. At the same time, many projects—especially those of an international nature—are also registered in the global database ClinicalTrials.gov, which is one of the most important clinical trial registries worldwide and is often required by scientific journals prior to publication of results.
For studies involving medical devices, the EUDAMED system is applicable, developed in accordance with the MDR and IVDR regulations. It includes the registration of sponsors, devices, clinical investigations of medical devices, and IVD performance studies. The aim of the system is to increase market transparency and enable effective oversight of the safety of medical technologies across the European Union.
The registration of observational studies is also gaining increasing importance, including non-interventional studies (NIS), post-authorization safety studies (PASS), and Real World Evidence projects. In Europe, the recommended registry for such studies is the EU PAS Register (ENCePP), operated under the auspices of the European Medicines Agency (EMA). Although registration in ENCePP is not always mandatory, it enhances the credibility of the project, supports transparency in pharmacoepidemiological research, and is often expected by regulators and scientific publishers. Observational studies may also be registered in ClinicalTrials.gov, particularly when the project is international or when publication of results is planned.
It is worth emphasizing that study registration does not end with a one-time data entry. The sponsor is also responsible for updating the study status, reporting protocol amendments, notifying study completion, and—in certain cases—publishing results within required timelines. Inconsistencies between study documentation and registry entries are among the common issues identified during audits and regulatory assessments.
For this reason, more and more sponsors seek CRO support already at the stage of planning the registration strategy. An experienced partner can assist in identifying regulatory obligations, selecting the appropriate registration system, preparing study descriptions consistent with the protocol, and managing ongoing updates required by individual platforms. This approach helps reduce formal risks and ensures consistency of information published across different databases.
If you are planning a study and want to ensure that its registration is carried out correctly and in line with current regulatory requirements, it is worth consulting the Biostat team. A well-designed registration strategy is not only a formal obligation but also a key element in building the credibility of the entire research project.
