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The primary use case for the CCD is to provide a snapshot in time containing the germane clinical, demographic, and administrative data for a specific patient. [ 8 ] Diagnostic Imaging Report - A Diagnostic Imaging Report (DIR) is a document that contains a consulting specialist's interpretation of image data.
The HL7 Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding, structure and semantics of clinical documents for exchange.In November 2000, HL7 published Release 1.0.
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]
On July 21, 2004, SDTM was selected as the standard specification for submitting tabulation data to the FDA for clinical trials and on July 5, 2011 for nonclinical studies. Eventually, all data submissions will be expected to conform to this format.
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
Richland, WA, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) is pleased to report that the first five patients demonstrated the safety of RadioGel Precision Radionuclide Therapy TM by satisfying the criteria in the Clinical Study Plan, including confirmation via PET imaging that the Y-90 remained at the point of injection and no adverse events reported by any of the initial five ...
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 ...
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 ...