How safe is a clinical study?
You are in good hands
How safe is it for me?
By the time we start up a study investigating a new medicine at SGS CPU, the application has been reviewed by a large number of people. The sponsor, our doctors, an independent ethics committee and national/international health authorities all independently need to give their approval. Only when all of these people and organisations are convinced that the clinical study investigating a new medicine can be conducted with the best safety precautions, it can be started. Your safety is also our absolute priority throughout the entire study from the start to the end.
Independent ethical and legal review
Every medicinal product study is carefully and independently reviewed before it starts by several authorities, including an independent ethics committee. This multidisciplinary group of healthcare experts weighs the scientific value of the study against the potential risks to participants.
The committee assesses, among other things, the study design, the quality of the protocol, the competence of the investigators, participant safety, and the completeness of the information provided to participants. Strict attention is paid to the voluntary nature of participation and to the protection of dignity, rights, and privacy, in accordance with Belgian and European legislation.
The review is conducted in line with internationally recognized guidelines, such as the Declaration of Helsinki and Good Clinical Practice (GCP). In Belgium, each study must also be approved by the Federal Agency for Medicines and Health Products (FAMHP) and comply with the European Clinical Trials Regulation.
Important: a positive opinion of an ethics committee or the FAMHP should never be the only encouragement for you to take part in a study. Any pioneer's decision to take part in any study is independent and voluntary.
Safety and follow-up within our research center
During and after the administration of the study medication, your health is always the top priority. You are monitored by an experienced team of physicians and nurses specialized in clinical drug research. Depending on the study, your health is followed through targeted assessments and tests, such as an ECG (electrocardiogram), measurements of vital signs, and blood and urine samples.
If abnormal values or symptoms occur, the physician will discuss this with you immediately and, if necessary, appropriate measures will be taken without delay.
The SGS CPU research center in Edegem is located on the campus of the Antwerp University Hospital (UZA), close to the emergency department. Should it exceptionally be required, emergency care can be provided rapidly on site. In addition, we have emergency procedures and medical equipment available to deliver immediate first-line care.
Beyond the medical team, each study remains under continuous oversight by the ethics committee, the competent authorities, and the sponsor. If new safety information becomes available, additional measures may be implemented, or the study may be amended or discontinued.
VIDEO - How is a lumbar puncture performed?
Would you like to know exactly what a lumbar puncture spinal tap is and how it works? We have created a short and clear explainer video in which you can see step by step what to expect.
Good to know not every study includes a lumbar puncture. When a spinal tap is part of a study we always mention this clearly on our study page and in the information sheet of the specific research. Watch the video and feel well prepared.
