Tag: GCP data capture

Contemporaneous Data Entry: Best Practices and Common Pitfalls

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Contemporaneous Data Entry: Best Practices and Common Pitfalls Best Practices for Contemporaneous Data Entry in Clinical Trials What Is “Contemporaneous” Data in the ALCOA Framework? The “C” in ALCOA stands for Contemporaneous, meaning that data should be recorded at the time the activity is performed. In the context of clinical trials, contemporaneous documentation is critical…

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Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA), Data Integrity and ALCOA+ Principles

Minimizing Data Entry Errors through Smart eCRFs

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Minimizing Data Entry Errors through Smart eCRFs How Smart eCRFs Can Help Reduce Data Entry Errors in Clinical Trials Introduction: The Cost of Poor Data Entry in Clinical Trials Data entry errors can cause protocol deviations, increase monitoring costs, delay database lock, and even jeopardize regulatory submissions. In today’s digital trial landscape, smart electronic Case…

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eCRF Design, Electronic Data Capture (EDC) and eCRFs