A clinical study protocol in clinical research outlines the entire study design, objectives, and methodologies. It typically contains study details that are pertinent to follow when conducting a clinical trial. If any deviations from the protocol occur, a protocol deviation form must be filed and submitted to the appropriate authorities. It’s important to focus on […]
Clinical sites are where studies are conducted, often in hospitals, private clinics, or specialized research facilities. These sites are responsible for recruiting participants, collecting data, and ensuring the trial is executed per protocol and regulatory standards. 1. Study Feasibility and Site Selection Before a site is selected, it has to go through a few steps. […]
To break into clinical research, it’s essential to grasp the fundamentals, including the educational qualifications needed, the roles of clinical sites, CROs (Contract Research Organizations), and sponsors, as well as the involvement of pharmaceutical, biotech, and medtech companies in the field. Additionally, understanding the various roles within clinical research and their responsibilities is crucial. To […]