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Laboratory Data Model (LAB) The Lab standard is used for the exchange of laboratory data between labs and CROs; Case Report Tabulation Data Definition Specification (CRT-DDS) Also referred to as "define.xml", a machine readable version of the regulatory submission "define.pdf". Clinical Data Acquisition Standards Harmonization (CDASH) [6]
To understand how a data definition specification works in an enterprise, we must look at the elements of a DDS. Writing data definitions, defining business terms (or rules) in the context of a particular environment, provides structure for an organization's data architecture. In developing these definitions, the words used must be traceable to ...
The LIMS then tracks chain of custody as well as sample location. Location tracking usually involves assigning the sample to a particular freezer location, often down to the granular level of shelf, rack, box, row, and column. Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may be required.
A laboratory specimen is sometimes a biological specimen of a medical patient's tissue, fluids, or other samples used for laboratory analysis to assist in differential diagnosis or staging of a disease process. These specimens are often the most reliable method of diagnosis, depending on the ailment.
An example of a Levey–Jennings chart with upper and lower limits of one and two times the standard deviation. A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well.
A certificate of analysis can be associated with cannabis and cannabis-derived products, attesting to their laboratory analysis for cannabinoids, adulterants, heavy metals, pesticides, mold, etc. This gives consumers "an easy way to review test results from responsible companies selling cannabis and cannabis-infused products". [12]
Traces can be stored indefinitely or written out to some external data storage device and reloaded. This allows, for example, comparison of an acquired trace from a system under test with a standard trace acquired from a known-good system. Many models can display the waveform prior to the trigger signal.
A good electronic laboratory notebook should be an "out of the box" solution that, as standard, has fully configurable forms to comply with the requirements of regulated analytical groups through to a sophisticated ELN for inclusion of structures, spectra, chromatograms, pictures, text, etc. where a preconfigured form is less appropriate.