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| clinical data management ： ウィキペディア英語版 |
clinical data management
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.〔http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/〕 Clinical Data Management assures collection, integration and availability of data at appropriate quality and cost. Clinical Data Management supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CRDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics.
==Role of the clinical data manager in a clinical trial==
job profile acceptable in CDM: Clinical researcher, Clinical research associate, Clinical research coordinator...etc
The clinical data management plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry. The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, the data manager ensures that data is collected, validated, complete and consistent. The clinical data manager liaises with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical data manager transfers data for statistical analysis
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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