Definition

The end-to-end discipline that ensures clinical trial data are collected, cleaned, traceable, and fit for analysis and submission.

Example

CDM designs the eCRF, defines edit checks, manages queries, and coordinates database lock deliverables.

Regulatory source

Industry practice aligned with GCP principles and quality management expectations.

Common mistakes

Treating CDM as only data entry or only query closure rather than a controlled lifecycle.

Inspector question

How do you demonstrate data integrity and traceability from data capture through database lock?

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