GCDMP
Good Clinical Data Management Practice
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The discipline and published industry guideline covering the collection, cleaning, validation, and management of clinical trial data — database design, data entry and query resolution, discrepancy management, coding, and database lock — so that clinical trial data supporting a marketing application is complete, accurate, and consistent.
GCDMP addresses the data-management activities that sit alongside clinical monitoring: designing the clinical database and edit checks, entering and querying data from case report forms or EDC systems, resolving discrepancies between the source and the database, coding adverse events and medications to standard dictionaries, and formally locking the database once data is confirmed clean.
Unlike GCP, which is codified in ICH E6, GCDMP is published as an industry best-practice guideline by the Society for Clinical Data Management, covering specific chapters such as data management planning, data validation, database closure, and metrics — it is treated as the data-management-specific complement to the broader GCP framework rather than a separate regulation.
Strong GCDMP practice is what makes ALCOA+ principles operational for clinical data specifically: query trails, audit trails on database edits, and documented database-lock procedures are the mechanisms by which clinical data integrity claims are actually demonstrated.
- —Focuses specifically on clinical database design, cleaning, and lock — not site conduct
- —Published by the Society for Clinical Data Management as an industry guideline
- —Complements ICH E6 GCP rather than replacing or duplicating it
- —Operationalizes data-integrity principles for clinical trial databases
Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices
Frequently asked questions
What does GCDMP stand for?
GCDMP stands for Good Clinical Data Management Practice.
What is GCDMP?
The discipline and published industry guideline covering the collection, cleaning, validation, and management of clinical trial data — database design, data entry and query resolution, discrepancy management, coding, and database lock — so that clinical trial data supporting a marketing application is complete, accurate, and consistent.
Which regulations cover GCDMP?
Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices