Written by: Stephanie Jansen-Kosterink

 

As you can read on our website, Roessingh Research and Development (RRD) conducts scientific research into innovative healthcare technology with a focus on the end-user. Part of our research falls under the heading of medical-scientific research. This type of research is subject to national and international laws and regulations, such as the Medical Research Involving Human Subjects Act (WMO) and the Medical Devices Regulation (MDR).  

At RRD, all researchers are in possession of a WMO-GCP registration. In 2015, I was one of the first at RRD to follow an external multi-day training to participate in the WMO-GCP exam. The training was very interesting. Much was known, especially the submission of a research protocol to a medical ethics review committee (MERC), but much was also unknown. What was new to me was the information about conducting medical research, such as the requirements of standard operating procedures (SOPs) for all parts of your research. The exam was very difficult. It had been years since I had taken an exam and the focus was mostly on the details. But luckily, the result was positive and I received my WMO-GCP registration. That was not the end of it. This registration is valid for 3 years, which means that every 3 years a re-registration is needed. The WMO-GCP re-registration deals with the WMO, Good Clinical Practice (GCP) guidelines, ISO14155 standard for research with medical devices and specific matters in the field of research involving human subjects, including the latest changes.

My registration was still valid until January 2023 and re-registration was required again. Wednesday 7 December, I was invited to Heeze and during the train journey to the south of the Netherlands I completed the WMO-GCP re-registration e-learning of the Tapas Group. I arrived at the certification questions when the train finally arrived at Eindhoven CS. Fortunately, all questions were correct and my registration was a fact!

Much of the research we conduct at RRD is scientific, but not always medical. Nevertheless, we choose to approach all our research in the first instance as medical-scientific. When we are sure that the research does not fall under the WMO, we always verify this with the METC East Netherlands. Even if it does not fall under the WMO, we continue to follow the GCP guidelines.

Are preparing research yourself, such as testing an intervention or a medical device? We will be happy to help you to draw up the research protocol and supervise the medical ethics review!

FOTO ERIC BRINKHORST

Stephanie Jansen-Kosterink

E-mail: s.jansen@rrd.nl

Tel: 088 087 5717