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Modifying rules to ignore EDC data

If you replicate Clintrial rules in the InForm study, both sets of rules are eligible to execute on the EDC data. Unless you modify the Clintrial rules to ignore EDC data, the following scenario occurs:

  1. A failing EDC rule immediately produces a query in the InForm software.
  2. A Clintrial rule failing on the same EDC data also produces a discrepancy that transfers to the InForm software during the synchronization that transfers the original clinical data.
  3. Users must resolve both queries in the InForm study.

Generally, making a data change clears the InForm query and the PDC rule discrepancy. However, depending on the timing of synchronizations, a user could have the experience of correcting an EDC data item and clearing the InForm query only to have the Clintrial rule generate a discrepancy on the same item.

To avoid this scenario, you can include an exception clause at the beginning of each Clintrial rule for which an equivalent EDC rule exists in the InForm database. Use the following syntax.

(IS_EDC_RECORD (CT_GLOBAL.CTS$PROTOCOL,
CT_GLOBAL.CTS$PANEL, CT_GLOBAL.CTS$CT_RECID)) OR
(original_rule_script)

For example, consider the following rule.

(this.HT between 50 and 84)

To disable the rule if the data source is EDC, make a call to the IS_EDC_RECORD function.

(ctproc.ct_edc_event.is_edc_record(ct_global.cts$protocol,ct_global.cts$panel, ct_global.cts$ct_recid )) OR (this.HT between 50 and 84)

The is_edc_record function returns true if the record source is EDC, and the Clintrial rule does not fire.

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