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Essentially, the MetaDataVersion section in the ODM contains all necessary information for a CRO about which data will have to be delivered to the sponsor, and in what format. Therefore, we constructed a tool which translates the data in the MetaDataVersion section into a set of SQL statements for database table generation.
This enables CROs and Data Management Companies to generate all necessary tables for a study within a few seconds, starting from a (partial) ODM file delivered by the sponsorFor example, the following <ItemGroupDef> element defines which items will be part of the group.
For convenience, an ItemGroup may be related to a table in a relational database: this will make writing to
and reading from (with subsequent transformation to XML which comes in the ClinicalData section) much more
easy.
Further in the MetaDataVersion, it is defined what kind of data types the Items in the ItemGroup correspond to, and how they should be formatted.
Our tool takes the data from the MetaDataVersion section, analyzes them, and transforms them to a set of SQL statements which can easily be used for generating the appropriate tables.
For example, if the datatype given in the ODM is defined as "text", with a maximum length of 20 (like the DOSEUNIT ITEM), and with an attribute 'Mandatory="yes"', this is translated into an SQL statement
Still to do:
This product is already available to our customers which have a consultancy agreement. Usually, it takes only 2-3 days of consultancy to have this product installed (and tailored to your own needs) at your site.
