The End of Trial (EOT) Declaration constitutes an essential regulatory obligation that mandates clinical trial sponsors to formally inform both regulatory bodies and ethics committees upon the completion of their clinical trials. This requirement holds significance across all trials, encompassing a pivotal juncture in the trial’s progression. Positioned between the Early Termination station and the Statistical Data Analysis station, the EOT station represents a crucial checkpoint in the trial’s timeline.
It follows a series of parallel processes including Safety Reporting, Progress Reporting, Ongoing Management and monitoring, GCP and serious Breach Reporting, as well as potential activities such as MHRA Inspection, Audit, Substantial Amendments, Addition of New Sites & Investigators, Temporary Halt, and Early Termination. By adhering to the EOT Declaration, trial sponsors fulfill their legal obligation, an imperative that extends to trials of all natures. This station is integral to the broader category of trial close-out phases, signifying the culmination of comprehensive trial-related activities.
Signal Management Process
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