Quality of research
At UMC Utrecht we strive for the highest possible quality when it comes to research, and make sure that all our research complies with laws and regulations.
New rules for medical devices
Since 26 May 2021, medical devices such as patches, artificial hips, pacemakers in Europe are subject to new regulations (MDR). This new legislation brings greater clarity and transparency for our patients, and helps them to make better choices between devices, and makes treatment even safer for them. To comply with this new legislation and support our researchers in this respect, we produced a special tool in 2021 that researchers can use to assess whether their study falls within the MDR. We have also provided comprehensive work instructions for clinical research with medical devices.
Clinical Trials Regulation
On 31 January 2021 the EU Clinical Trials Regulation (CTR) came into force. This legislation governs clinical research in Europe and aims to simplify and accelerate clinical trials with medical products so that these can be made available to patients faster. In practice, the CTR means that there is a new process for starting clinical trials. To prepare our research for this, in 2021 we developed for example a detailed procedure for filling in the accompanying form for the ‘Declaration of suitability of clinical trial facility sites’, and clearly set out all the requisites and contact details of the supporting departments, including the lab, X-ray department and core function. This has also led to better internal procedures in these departments.
Quality manual for research on human subjects
To improve the traceability and application of the UMC Utrecht-wide research policy and procedures, we started at the end of 2019 to establish a quality manual for research on human subjects, in accordance with the research cycle (scheduling, setting up, executing and finishing off a trial). We finalized this manual at the end of 2021. The manual also shows our research organization with descriptions of the roles and responsibilities involved, and how quality is monitored both internally and externally. In 2022 we continued to develop the manual for research on animal subjects and pre-clinical studies.