What is meant by “risk assessment” in GCP?

In the context of Good Clinical Practice (GCP), "risk assessment" refers to the process of evaluating potential risks and benefits associated with conducting a clinical trial. This assessment is crucial as it helps ensure the safety and well-being of trial participants while also considering the scientific validity of the study. The identification and evaluation of risks involve looking at various factors, including the likelihood and severity of adverse events, as well as the potential benefits that may result from the trial for participants or the wider community.

Although evaluating participant benefits is an essential part of ethical research, it doesn't encompass the comprehensive nature of risk assessment, which includes a balance between both risks and benefits. Likewise, identifying treatment options is a part of clinical planning but not the precise focus of risk assessment in the context of GCP. Assessing only financial risks to the sponsor ignores the critical aspect of participant safety and ethical considerations in trial conduct, which is an integral part of the GCP framework. Thus, considering both potential benefits and risks leads to informed decision-making regarding the trial's design and execution, making the assessment of risks and benefits the correct definition of risk assessment in GCP.