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Deletion and undeletion processing

When EDC data is deleted in the InForm software and the action is synchronized to the Clintrial software, the CIS software processes deletions and other related transactions in the Clintrial tables as follows.

InForm action

Clintrial table updates

Delete a record.

  • Data—Delete the corresponding UPDATE and DATA table row, and add a record to the AUDIT table, containing a copy of the data before deletion.
  • Comments—Delete the corresponding row from the TAGS table.
  • Discrepancies—Auto-close discrepancies on the deleted records, and rerun validation on any panels that have discrepancies with error items that refer to the deleted records.

Add a comment to a deleted record.

Add a record to the TAGS_AUDIT table.

Add a query to an empty form.

Create a record in the UPDATE table for the panel to which the InForm item is mapped, if the InForm item is mapped to the Clintrial software. If the InForm path for the query is mapped to multiple Clintrial panel items, CIS creates a query record for only one of the mappings.

Add a query to a deleted record.

Discard the query.

Undelete an itemset row or repeating form instance.

  • Data—Create a row in the UPDATE table, using the CTRECID of the data from before the deletion, obtained from the AUDIT table. Populate the row with data from the AUDIT table.

    If a patient number changes in the InForm software, and then a deleted record associated with that patient is undeleted, the AUDIT table used to obtain the rest of the deleted data holds the old patient number. In this case, CIS obtains the new patient number from the enrollment panel.

    For protocols started before CIS 4.0 SP4—Until the 4.0 SP4 release, CIS did not delete records in the Clintrial software when processing an InForm delete transaction. Instead, CIS set items in the UPDATE table to NULL. These all-NULL records might still exist in the Clintrial database. CIS processes an undelete on these records as follows:

    • If the UPDATE table already includes a row for the itemset or repeating form record containing all NULL values, update the row with the itemset or repeating form values, using data from the AUDIT table.
    • If the DATA table already includes a row for the itemset or repeating form record containing all NULL values, delete the row in the DATA table and insert a row in the UPDATE table, using data from the AUDIT table.

      It is possible for CIS to transfer data from the InForm software to a record that contains all NULL values. If such a data transaction is then followed by an undelete, synchronization fails. In the very unlikely event that a failure occurs because of this circumstance, please contact Oracle support for assistance.

  • Comments—Recover any deleted comments from the TAGS_AUDIT table.
  • Discrepancies—CIS does not recover any deleted discrepancies. To recover a manual query, a user must re-enter the query. Validation must be run again to open discrepancies.

Caution: A delete or undelete action can affect multiple rows in multiple panels.

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