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A Clinical Data Repository (CDR) or Clinical Data Warehouse (CDW) is a real time database that consolidates data from a variety of clinical sources to present a unified view of a single patient. It is optimized to allow clinicians to retrieve data for a single patient rather than to identify a population of patients with common characteristics ...
The Janus data model is a relational database model, and is based on SDTM as a standard, in terms of many of its basic concepts such as the loading and storing of findings, events, interventions and inclusion data. However, Janus itself is a data warehouse independent of any single clinical trials submission standard.
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
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. Systems for ...
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]
Oracle Clinical or OC is a database management system designed by Oracle to provide data management, data entry and data validation functionalities to support Clinical Trial operations. [1] The Major Functions Supported by Oracle Clinical are: Clinical Study Database Design; Definition of Clinical Study Metadata to be collected
From January 2008 to December 2012, if you bought shares in companies when Gary W. Loveman joined the board, and sold them when he left, you would have a 3.6 percent return on your investment, compared to a -2.8 percent return from the S&P 500.
Interoperability between disparate clinical information systems requires common data standards or mapping of every transaction. However common data standards alone will not provide interoperability, and the other requirements are identified in "How Standards will Support Interoperability" from the Faculty of Clinical Informatics [2] and "Interoperability is more than technology: The role of ...