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Showing posts with the label EPOCH Assignment for Pre-Consent Data

Understanding EPOCH Assignment in Clinical Trials: The Pre-Consent Data Challenge

In the world of clinical trials, data management and standardization play crucial roles in ensuring the quality and integrity of research outcomes. One particularly nuanced aspect of this process is the proper assignment of EPOCH values in SDTM (Study Data Tabulation Model) datasets, especially when dealing with pre-consent data. What is an EPOCH? An EPOCH in clinical trials represents a distinct period within the study's planned design. It helps organize and contextualize various events, interventions, and findings that occur during the study. Common EPOCHs include SCREENING, TREATMENT, FOLLOW-UP, and others as defined by the study protocol. Essential EPOCH Characteristics: It is a standardized way to identify different phases of a study Each EPOCH represents a planned element of the study design EPOCHs help establish temporal relationships between different study e...