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Whilst the DIA doesn't have a formal, public and open standards effort in place to develop a formal, published standard, the use of the Reference Model is helping industry to standardize on the content of the trial master file, on the nomenclature for trial master file artifacts and on the taxonomy used.
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Data analysis is generally challenging for DIA methods as the resulting fragment ion spectra are highly multiplexed. In DIA spectra therefore the direct relation between a precursor ion and its fragment ions is lost since the fragment ions in DIA spectra may potentially result from multiple precursor ions (any precursor ion present in the m/z range from which the DIA spectrum was derived).
The ODM schema is generally divided into three categories of data: Metadata, Admin data, and Clinical data. Metadata describes the structure of the eCRFs within the study, and how they relate to scheduled visits. Admin data contains references to users, locations, and any additional non-structural and non-clinical reference data.
CAD: computer-aided design, computer-aided drafting; cadmium [plating]: CAGE: Commercial and Government Entity [code]: A CAGE code is a unique identifier to label an entity (that is, a specific government agency or corporation at a specific site) that is a CDA, ODA, or MFR of the part defined by the drawing.
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