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Metadata in an integrated study
In an integrated study, the Clintrial protocol is used primarily to store, merge and analyze clinical data. Verified data enters the Clintrial UDPATE tables with status set to 0 (passed validation) or -1 (failed validation) using the EDC and synchronization capabilities of the InForm software. Rules identified with items in the Clintrial software generate InForm queries after synchronization is completed. These queries are resolved using the InForm software.
Although you do not typically define blocks (visits), page templates (forms) or page sections (sections) in an integrated study, these elements may exist in the Clintrial protocol. This situation could arise if you synchronized an integrated study to an existing Clintrial protocol rather than creating or updating a new protocol.
All instances of a form within an InForm study store clinical data in one Clintrial panel. Columns in the database table are required to associate the clinical data with a specific patient, visit and form. These columns in the database table consist of either of the following:
- InForm RefNames (subject, visit, form, visit index, and form index). This is the case if study metadata in the InForm software is not based on a Clintrial protocol created with the Clintrial Design module.
- Clintrial context items and system items. This is the case if study metadata in the InForm software is based on a Clintrial protocol in which context and system items are defined and synchronized to an existing or new Clintrial protocol.
The InForm software may create metadata for items differently than would be the case with the Clintrial software. A checklist with override attribute set in the Clintrial software generates one item, while the InForm software generates two items by default.
For more information, see Corresponding Clintrial and InForm metadata objects.
Complex controls in the InForm software can contain nested controls. The controls translate to items in the Clintrial software but the relationship between items is not defined.
