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Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
The Society for Clinical Data Management (SCDM) [3] has created the Good Clinical Data Management Practices (GCDMP©) standard, [4] 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 ...
[3] [4] OMOP developed a Common Data Model (CDM), standardizing the way observational data is represented. [3] After OMOP ended, this standard started being maintained and updated by OHDSI. [1] As of February 2024, the most recent CDM is at version 6.0, while version 5.4 is the stable version used by most tools in the OMOP ecosystem. [5]
Eventually, all data submissions will be expected to conform to this format. As a result, clinical and nonclinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management.
Pages in category "Clinical data management" The following 34 pages are in this category, out of 34 total. This list may not reflect recent changes. ...
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