Clinical data

UPDATE, DATA, and AUDIT clinical data tables

When a panel defining a set of clinical data items is installed, the Clintrial software creates one of each of these tables. The name of the table is in the format panelname_tabletype, for example, DMG_DATA.

• UPDATE—When a user first enters data, it is stored in the update table. The update table stores data that has not been merged.
• DATA—After data passes validation in the update table, you can merge, or move, the data to the data table.
• AUDIT—The audit table stores copies of clinical data records as they existed before modification or deletion. Data in the audit table cannot be changed. Clintrial protocol data can be audited after data entry or after validation. EDC data transferred from an integrated study is audited after data entry.

Clintrial discrepancy data

VCT tables

These tables, VCT_ERRORITEM_UPDATE and VCT_ERRORSTATUS_UPDATE, are copied from the CTVRESOLVEREF protocol into each protocol that you set up as a Resolve protocol. These tables track items that are associated with a discrepancy.

Error data

ERRORLOG table

This table stores information about errors that occur during screening, validation, merging, and global change or deletion.

Flag and note data

TAGS tables

This table stores information about flags and notes that are attached to clinical data.

EDC protocol management data

INF_ tables

When CIS synchronizes a protocol used for EDC data to Clintrial software, it creates a set of tables to hold information required for processing the EDC data. These tables hold:

• Query data—These tables track items that are associated with queries generated by Clintrial rules on EDC data. The tables have the same columns as the corresponding VCT tables in the Clintrial software, except that the INF_ERRORSTATUS tables have an extra column for QUERYGUID.
• Mapping specifications—These tables identify the correspondences between the InForm software and Clintrial software study objects.
• Non-clinical study data—These tables store InForm site and user information.
• Status—These tables store form and item state information.
• Other tables—Additional EDC data tables store information about study objects that require special handling, such as calculated items; synchronization errors; the audit trail for edited transactions; and outgoing transactions sending queries back to the InForm software.

  The names of these tables have the prefix INF_.