Data reporting metadata

In the construction of the database, special attention was paid to the harmonisation of formats of data and metadata reporting, such as measurement units, in order to improve inter-comparability of the data among all EU Member States. The data collection formats recently proposed for harmonisation at the EU level (INERIS, 2007) are already incorporated in the database structure. Recommendations made by other international bodies such as lUPAC (e.g. Egli et al., 2003) were also taken into account. 

The agreed formats of data and metadata reporting, the minimum requirements for establishment of new databases of emerging substances, and the set of moni-tored/measured parameters needed for risk assessment (including requirements with respect to data precision and spatial and temporal resolution) will be disseminated across Europe as a guidance document. 

What metadata are required for data reporting to the EU Commission under the WED ... 

In general it is still difficult in the current monitoring programmes to access metadata such as the measurement methods employed, the detection limits of the methods and details of the quality assurance/quality control (QA/QC) procedures associated with the reported monitoring activities. What metadata are required for data reporting to the EU Commission under the WED ... 

WHAT METADATA ARE REQUIRED FOR DATA REPORTING TO THE EU COMMISSION UNDER THE WED ... 

The metadata inclnded in the EU data reporting template are reported in Table 9.1.1. Each field in the template is labelled according to the final use of the information collected ... 

In line with the above, a nnmber of QA/QC metadata were selected in the common template for data reporting at EU level nnder the WED, but not all of them are mandatory (i.e. they are not Category 1 data), as can be seen in Table 9.1.1. 

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. 

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. 

In this light it is imperative that the archival strategy and validation effort for a database consider metadata. If metadata is incompletely copied, records restored from archive will not be properly retrievable and/or reported. Ergo, it is imperative that the database functionality be challenged again with restored records after it has been fonnd acceptable with normal data. 

It is important to preserve or translate as much of the original form and format of the data as possible, and that includes metadata. A database can contain a tremendous amount of metadata, such as audit trail information, electronic signatures, relationships between database tables, definition of field characteristics, etc. It is necessary to consider this metadata as part of the data set failure to do so could inhibit searchability and reporting after migration, make modification of old records problematic, or possibly even result in loss of the integrity of the records. Validation tasks associated with data migration must be geared to demonstrate that neither of these circumstances prevails. 

Knowledge of whether dissolved or total metal was measured is the first crucial information. Moreover, in order to enable further investigation of the bio-available fraction from the measured concentration in the dissolved fraction, additional parameters have been included in the reporting template (see Table 9.1.2). They are classified as Category 2 metadata (i.e. non-mandatory information in the current prioritisation process). These parameters (metadata) are also mentioned in the EIONET-Water template, but actual data are not often reported and not readily available in most of the existing databases. 

The archiving standard PDF/A-3 and the unification of source standards for chromatographic data, together, generate a real future opportunity to ensure independence of manufacturers and systems for chromatographic data as report data, including all metadata, as well as their processing (reprocessability). With the realization of the above-mentioned options, the demands of some auditors are obsolete to keep older computers, software, and expertise in a validated environment, to possibly have access to older data. 

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