Metadata

Figure 5-2. The database(s) (DB) with organized data and metadata are part of the Database SysteiTi (DBS), which is managed by the Database Management System (DBMS).

The characteristic of a relational database model is the organization of data in different tables that have relationships with each other. A table is a two-dimensional consti uction of rows and columns. All the entries in one column have an equivalent meaning (c.g., name, molecular weight, etc. and represent a particular attribute of the objects (records) of the table (file) (Figure 5-9). The sequence of rows and columns in the tabic is irrelevant. Different tables (e.g., different objects with different attributes) in the same database can be related through at least one common attribute. Thus, it is possible to relate objects within tables indirectly by using a key. The range of values of an attribute is called the domain, which is defined by constraints. Schemas define and store the metadata of the database and the tables. 

All the methods of obtaining information via the Internet presented above carry one risk - dead links. Although a search term may be found by a search engine in its own website-metadata database, the original link to the website could be broken and the information is lost. In this book a conscious effort has been made to limit the URLs and to reduce the web address to the index page of the seiwer, to avoid this sometimes annoying problem. 

Direct instrument control (or the lack of it) was an important issue for the earlier version of CDS. The scheme of connecting the detector channels through A/Ds to CDS worked well in analytical laboratories across the pharmaceutical industry. The scheme provided enough flexibility so that the CDS could collect data from a variety of instruments, including GC, HPLC, IC, SFC, and CE. It was equally important that the CDS could be connected to instruments that were manufactured by different vendors. It was not uncommon to find a variety of instruments from different vendors in a global pharmaceutical research company. The disadvantage of this scheme was that the instrument metadata could not be linked to the result file of each sample analyzed. It could not be guaranteed that the proper instrument parameters were used in sample analysis. Another need came from the increased use of... 

Web in the life of the medicinal chemist. One may see the development of alerting services for the primary medicinal chemistry journals. The Web-based information search process could be replaced by a much more structured one based on metadata, derived by automated processing of the original full-text article. To discover new and potentially interesting articles, the user subscribes to the RSS feeds of relevant publishers and can simply search the latest items that appear automatically for keywords of interest. The article download is still necessary, but it may be possible for the client software to automatically invoke bibliographic tools to store the found references. Another application of the Chemical Semantic Web may be as alerting services for new additions to chemical databases where users get alerts for the new additions of structures or reactions. 

Computer applications allow for defining and managing several important nonclinical data types that are managed by the system itself. Such data are referred to as metadata or control data. These are information such as domain-specific descriptions, application conditions, parameters, and methods in a repository. Control data fields can be part of the data collection forms or in system-defined tables. Some of these control fields include electronic signatures, form status, transmission date, transmission number, field completed, and memo fields (large text format). The database contains tables for reference ranges, visit schedule, form schedule, labels, and drug codes. 

Can the agency query the data (not simply to visually inspect) Demonstrate retention of metadata. 

Case Report Tabulation Data Definition Specification (Define.xml). Define.xml is the upcoming replacement for the data definition file (define.pdf) sent to the FDA with electronic submissions. Define.xml is based on the CDISC ODM model and is intended to provide a machine-readable version of define.pdf. Because define.xml is machine readable, the metadata about the submission data sets can be easily read by computer applications. This allows the FDA to work more easily with the data submitted to it. 

Obs StudyOID MetaData VersionOID Subject Key StudyEvent OID StudyEvent RepeatKey... 

O PROC CDISC requires a number of parameters that specify the clinical trial metadata not typically found in your SAS data sets. These parameters can be specified within PROC CDISC or in separate data sets that can be passed to the procedure. This example chooses the latter method. 

Internal ODM markup required metadata [Pg.270]

The resulting ODM XML file produced by the XML LIBNAME engine is very similar to the one produced by PROC CDISC. However, PROC CDISC allows you to specify and pass more of the metadata information along to the XML file. If you need to create customized XML files for a sponsor that do not match the ODM specification, you can use the SAS XML Mapper and the XML LIBNAME engine to write your own custom XML files. 

FGDC 1998. FGDC-STD-001-1998. Content standard for digital geospatial metadata (revised June 1998). Federal Geographic Data Committee. Washington, D.C. 

Spirito, W.A. Adcock, S.W. 2009. The Canadian Database of Geochemical Surveys Metadata for 600 geochemical surveys across Canada. Geological Survey of Canada Open File 5934, 1 CD-ROM. 

The current distribution of geochemical data available through the national repository (OZCHEM database) is shown in Figure 1. The map shows that there are vast areas of the country (>60%) that lack any geochemical information. Also, where geochemical data are available, they are often not comparable as a result of incompatible sampling media, inconsistent sample preparation and analysis methods, incomplete quality assessment metadata and/or different analyte suites being reported. 

Scale (10n km"2) Number of elements Sample media Analytical techniques Data quality Metadata quality Availability QAQC... 

Figure 7 shows the relationship between a raw data channel and its associated metadata. If we were to choose the item highlighted Instrument Method , the embedded relational database would retrieve the exact version of the instrument method that was used to acquire the raw data. All this occurs in a fraction of a second. Imagine how long it would take using a conventional flat-file system (see Figure 8). 

FIGURE 7 Related information (metadata) is accessed using a CDS with an embedded database. 

Capsules, extended-release 10, 20, and 30 mg c-ii) Metadata CD (Celltech), Ritalin LA (Novartis)... 

Narcolepsy (except Concerta, Metadata CD, and Ritalin L/Aj Treatment of narcolepsy. 

ER capsules (Ritalin LA, Metadata CD) Administer once daily in the morning before... 

Metadata CD The early peak concentrations (median) were reached approximately 1.5 hours after dose intake, and the second peak concentrations (median) were reached approximately 4.5 hours after dose intake. 

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