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Planning Customer-Defined Database mappings
A Customer-Defined Database (CDD) is a database that gives sponsor personnel access to the data being collected in a trial while the trial is ongoing and when it is completed. Sponsors can review the data as needed to spot results that might require protocol adjustments or warrant early statistical analysis.
The structure of a CDD reflects the types of data analysis a sponsor wants to perform. As such, it does not match the structure of the InForm application trial database. To deliver trial data in the sponsor-specified database structure, the InForm application enables you to create a set of CDD mapping definitions that specify:
- Where each mapped data point comes from in the source trial.
- Where each mapped data point goes in the CDD.
- How the data is organized in the CDD.
- Optional, supplemental text about the design of the components in the CDD definition.
- Optional label text that is transferred to the CDD along with the data values.
When you think about how to define CDD mappings, start with the database specifications developed by the sponsor. Consider how you want to be able to retrieve the data from the CDD, including:
- Do you want to map multiple data points to the same CDD table column?
- Do you want to repeat a particular data point in each row of the table?
- Do you want to combine data from different visits, forms, or sections in the same CDD table?
- How do you want date and time data to be accessed—in a single string, in two strings with date and time segments separated, or in six strings with each component separated?
- Do you want individual checkboxes or radio buttons to be in separate columns, or do you want a single column to hold the data for the checkbox or radio group?
