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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.
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
Download as PDF; Printable version; In other projects Wikidata item; ... Pages in category "Clinical data management" The following 34 pages are in this category, out ...
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.
Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number.
ODM is a vendor-neutral, platform-independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. [8] ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012. [9]
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.