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Options for EDC data validation
You can validate paper-based data only with Clintrial rules and derivations. You can validate EDC data with:
- Central Designer data-entry rules—After Central Designer data-entry rules are deployed to an InForm study, they fire and update items like InForm rules and calculations. You should consider using Central Designer data-entry rules for EDC data validation if:
- You desire immediate feedback on data entry.
- You prefer the flexibility and ease of use of the Central Designer Rule Wizard, rule model, and rule expression language.
- Clintrial rules and derivations—When you attach a Clintrial rule to a panel holding an EDC data item, validation runs automatically when the data is synchronized from the InForm software to the Clintrial software. If the rule fails, the discrepancy generated by the Clintrial software synchronizes back to the InForm software as a Clintrial-originating query. Therefore, receipt of the query in the InForm software is not immediate but depends on the timing of synchronization. You should consider using Clintrial rules for EDC validation if:
- Immediate feedback on data entry is not a priority.
- You already have a suite of Clintrial rules developed for a paper-based study that you are extending to include EDC sites.
- You have a library of standard rules based on Clintrial trials.
- You prefer writing rules with PL/SQL.
- Both InForm or Central Designer rules and calculations, and Clintrial rules and derivations.
