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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 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 ...
Reye's syndrome, for example, is a potentially fatal complication of aspirin therapy in children that is very rare in adults. The 2002 Best Pharmaceuticals for Children Act, allowed the FDA to request National Institutes of Health-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints.
The analysed data are compiled into clinical study report and sent to the regulatory authorities for approval. Most of the drug manufacturing companies are using Web-based systems for capturing, managing and reporting clinical data. This not only helps them in faster and more efficient data capture, but also speeds up the process of drug ...
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 ...
Apache cTAKES: clinical Text Analysis and Knowledge Extraction System is an open-source Natural Language Processing (NLP) system that extracts clinical information from electronic health record unstructured text. It processes clinical notes, identifying types of clinical named entities — drugs, diseases/disorders, signs/symptoms, anatomical ...
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The Child Behavior Checklist (CBCL) is a widely used caregiver report form identifying problem behavior in children. [1] [2] It is widely used in both research and clinical practice with youths. It has been translated into more than 90 languages, [3] and normative data are available integrating information from multiple societies. Because a ...