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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.
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 ...
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.
PROMIS has worked to unify the field of patient-reported outcome (PRO) measurement through the promotion of a common, systematic measurement system broadly applicable across clinical research. PROMIS measures are intended to assess the most common or salient dimensions of patient–relevant outcomes for the widest possible range of chronic ...
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]
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.
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 ...
Health care analytics is the health care analysis activities that can be undertaken as a result of data collected from four areas within healthcare: (1) claims and cost data, (2) pharmaceutical and research and development (R&D) data, (3) clinical data (such as collected from electronic medical records (EHRs)), and (4) patient behaviors and preferences data (e.g. patient satisfaction or retail ...
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