Welcome back to the ongoing series where we delve deeper into the Trial Master File (TMF) in clinical trials. In our previous discussion, we took a closer look at the crucial documents required prior to the commencement of a clinical trial. Today, we venture into the heart of the trial process—the clinical conduct phase. This phase is pivotal, involving direct engagement with participants and the acquisition of essential data. It’s a period marked by dynamic changes, demanding meticulous documentation to ensure adherence to standards of Good Clinical Practice (GCP) and regulatory compliance.
Essential Documents During the Clinical Conduct
As the clinical phase unfolds, additional documentation becomes imperative to ensure ongoing compliance, data precision, and participant well-being. Let’s explore these key documents and their indispensable roles during this phase: