What is typically the focus of periodic site visits?

Periodic site visits primarily focus on reviewing informed consent adherence. During these visits, the study team assesses whether the informed consent process has been properly followed, ensuring that participants are fully informed about the study's purpose, risks, and benefits before enrolling. This is crucial for upholding ethical standards in clinical research, as informed consent is fundamental to protecting participants' rights and welfare.

By emphasizing adherence to informed consent, the study monitors compliance with regulatory requirements and the protocols established for the trial. This includes checking if participants have provided consent voluntarily and have been given sufficient information to make an informed decision regarding their participation.

While other factors, such as patient recruitment rates and the overall management of investigational agents, are important components of clinical trial oversight, the core aim of periodic site visits specifically prioritizes the review of informed consent to ensure the ethical integrity of the trial. Evaluating data analysis methods usually occurs at different stages of research, particularly during the analysis phase, rather than during routine site monitoring visits.