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Clinical data management (CDM) is a critical process in clinical research, ... Data validation is the application of validation rules to the data. For electronic CRFs ...
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.
[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]
A data clarification form (DCF) [1] or data query form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or contract research organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data ...
Data validation is intended to provide certain well-defined guarantees for fitness and consistency of data in an application or automated system. Data validation rules can be defined and designed using various methodologies, and be deployed in various contexts. [1]
A common data model (CDM) can refer to any standardised data model which allows for data and information exchange between different applications and data sources.Common data models aim to standardise logical infrastructure so that related applications can "operate on and share the same data", [1] and can be seen as a way to "organize data from many sources that are in different formats into a ...
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Conceptual data model (CDM) Logical data model (LDM) Physical data model (PDM) Includes high-level data constructs Includes entities (tables), attributes (columns/fields) and relationships (keys) Includes tables, columns, keys, data types, validation rules, database triggers, stored procedures, domains, and access constraints