Site monitoring and management is a critical aspect of clinical trial management, as it involves the oversight of study sites to ensure that the trial is being conducted in compliance with the protocol, relevant laws and regulations, and Good Clinical Practice (GCP) guidelines.
Site monitoring is typically carried out by a team of
professionals known as clinical research associates (CRAs). CRAs are
responsible for visiting study sites to assess the conduct of the trial, review
study documentation, and ensure that the rights and welfare of study subjects
are protected. CRAs may also provide training and support to study staff, and
help to resolve any issues or challenges that may arise during the trial.
Site management involves coordinating the activities of the
study sites, including recruiting and enrolling study subjects, collecting and
managing study data, and ensuring that the trial is conducted in accordance
with the protocol and GCP guidelines. Site managers may also be responsible for
managing budgets and resources, and coordinating with the study sponsor,
regulatory authorities, and other stakeholders.
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Regulatory