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Storage of query and discrepancy information
Query and discrepancy information for an integrated study is stored in the Clintrial database. Query information from EDC data entered with the InForm software is stored both in the InForm database and in a set of query tables in the Clintrial database that have the same structure as the Resolve module tables. The following table shows the Resolve table names, and the equivalent query data table names.
Resolve table |
Query table |
|---|---|
VCT_ERRORITEM |
INF_ERRORITEM |
VCT_ERRORSTATUS |
INF_ERRORSTATUS |
The INF_ query tables only store query information resulting from EDC study data. Discrepancy information resulting from data entered with the Enter module is stored in the Resolve tables if the Resolve module is installed. Updates of the query tables are slightly different for EDC data and data entered with the Enter module:
- When the failure of a rule on EDC data generates a query, the CTS$REASON column of the INF_ERRORITEM and INF_ERRORSTATUS tables is updated with the message The rule is not satisfied. When a query is closed, the CTS$REASON column of the INF_ERRORSTATUS table changes to The rule is satisfied. The CTS$REASON column of the INF_ERRORITEM table is not updated for the closing action.
Note: The INF_ERRORSTATUS_AUDIT table is not updated until the query is answered. This is consistent with audit processing for other patient data in Clintrial software. Clintrial software stores data in its UPDATE tables until it has been changed. Then it reflects the change in the corresponding AUDIT table.
- In the Resolve module, the query tables are updated when data entered with the Enter module results in a discrepancy. The CTS$REASON column of the VCT_ERRORSTATUS table is updated with the message The rule is not satisfied. When a query is closed, the CTS$REASON column of the VCT_ERRORSTATUS table changes to The rule is satisfied. The CTS$REASON column of the VCT_ERRORITEM table is not updated for either action.
