Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA)

ALCOA Checklist for Clinical Trial Monitors

Posted on digi By digi

Clinical Research Associates (CRAs) are the primary line of defense in ensuring that trial data is collected, documented, and verified in compliance with ALCOA principles—Attributable, Legible, Contemporaneous, Original, and Accurate. During site monitoring visits, it’s critical that CRAs are equipped not only with protocol and SOPs, but also with a structured tool to evaluate documentation quality.

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

How to Implement ALCOA Principles in Clinical Data Management Systems

Posted on digi By digi

In modern clinical research, most data is captured, stored, and processed electronically. This transition from paper to digital records has made Clinical Data Management Systems (CDMS) central to ensuring data quality and integrity. To meet global regulatory expectations—including those of the FDA, EMA, and ICH E6(R2)—all electronic systems must comply with ALCOA principles.

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