A clinical trial protocol is the master plan that keeps a study ethical, compliant, and operationally stable. It defines objectives, endpoints, eligibility criteria, safety processes, and documentation standards. Without a strong protocol, trials fail through inconsistency, deviations, and weak data credibility. This article breaks down clinical trial protocols by: • Explaining core protocol sections and why each one matters • Showing how protocols protect patient safety and data integrity • Cla
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In a 40-year career, this researcher had never seen anything like it: 14 protocol changes during a Phase 3 trial — nine after the trial began, and five more at the end. Constantly shifting the criteria raises serious concerns about data integrity and transparency. More startling, the vaccine’s clinical trial protocol was created in December 2019 — weeks before COVID-19 was declared a global health emergency, and months before it was labeled a pandemic — prompting questions about how early inside
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