Definition

The systematic process of reviewing adverse event cases for completeness, accuracy, and compliance before regulatory submission or database finalization.

Example

Before an expedited ICSR is submitted, a QC reviewer verifies the MedDRA coding is accurate, the narrative matches source documents, and all mandatory fields are populated correctly.

Regulatory source

EU GVP Module I, ICH E2D

Common mistakes

Treating QC as a simple checklist without clinical context. Effective QC requires understanding the case to identify logical inconsistencies.

Inspector question

Describe your QC process. What percentage of cases undergo QC, and what are your rejection/return rates?

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