Good clinical data management practice

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Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes. The U.S. Food and Drug Administration{{cite web |title=Guidance for Industry Computerized Systems Used in Clinical Investigations |url=https://www.fda.gov/media/70970/download |website=fda.gov |access-date=4 July 2024 |archive-date=16 May 2024 |archive-url=https://web.archive.org/web/20240516204621/https://www.fda.gov/media/70970/download |url-status=live }}{{cite web |title=Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application |url=https://www.fda.gov/media/75414/download |website=fda.gov |access-date=4 July 2024 |archive-date=18 March 2024 |archive-url=https://web.archive.org/web/20240318235838/https://www.fda.gov/media/75414/download |url-status=live }} and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use have provided specific regulations and guidelines surrounding this component of the drug and device development process. The effective, efficient and regulatory-compliant management of clinical trial data is an essential component of drug and device development.

The Society for Clinical Data Management (SCDM){{Cite web|url=https://scdm.org/|title=Home|date=May 22, 2024|website=Society for Clinical Data Management (SCDM)|access-date=October 12, 2020|archive-date=October 17, 2020|archive-url=https://web.archive.org/web/20201017232023/https://scdm.org/|url-status=live}} has created the Good Clinical Data Management Practices (GCDMP©) standard,{{Cite web|url=https://scdm.org/gcdmp/|title=GCDMP©|access-date=2020-10-12|archive-date=2020-10-12|archive-url=https://web.archive.org/web/20201012194735/https://scdm.org/gcdmp/|url-status=live}} a comprehensive document that provides guidance on accepted practices of clinical data management (CDM) that are not totally covered by current guidelines and regulations. This document is updated by Subject Matter Experts on a continuous basis.