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Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also 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 CDM is to ensure that conclusions drawn from ...
You can set the switch |help=on in the template to produce some quick pointers. When you are getting started, you might want to use {{Graphical timeline|help=on}} to generate a ready-made, empty template – or type {{subst:Graphical timeline/blank}} into a sandbox page, save the page, and edit the resulting code. Hopefully, the parameter names ...
For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
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 ...
A project plan, is a series of structured tasks, objectives, and schedule to a complete a desired outcome, according to a project managers designs and purpose.According to the Project Management Body of Knowledge (PMBOK), is: "...a formal, approved document used to guide both project execution and project control.
Article 58 requires that "the sponsor and investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial." This requirement defines a minimum retention period across the EU for all clinical trial master files, irrespective of whether the data subsequently supports a marketing ...