Safety in brief
Safety in clinical research has a fundamental role: keeping the safety of patients in mind at all times. Safety professionals keep a bird’s-eye view on the risk–benefit ratio of a clinical research project, while never losing sight of the patient who is directly involved. The figure of the patient represents the many who are currently taking part, as well as all others who in future may benefit. Safety management starts well before patients are involved, by anticipating likely scenarios and implementing risk mitigating measures, and then following the process through to its conclusion. During trial conduct, the patient risk–benefit is continuously assessed and if necessary, should things deviate from the expected path, the safety team carries out safety measures immediately.
Safety staff inform investigators and authorities about the occurrence of adverse events and its mitigating measures if need be, as well as patients so they can give informed consent to continued participation in the clinical research project.
More detailed information about this topic can be found in the fact sheet below.