Data Validation
The data validation plan (list of electronic and manual consistency checks) will be developed by IDDI and reviewed by Sponsor. The electronic edit-checks will be progammed using SAS, tested and validated on dummy data. For complex checks that cannot be programmed, manual DCFs (Data Clarification Forms) will be generated.
The answers to the queries will be sent back to IDDI and integrated into the database, all data changes being traced in the database through an audit trail.
Query tracking reports will be made available on TrialControl, IDDI's secure web portal, allowing Sponsor to follow-up the number and status of queries.
With regard to EDC, most edit-checks will be built in the system. For complex checks that cannot be programmed in the EDC system, they will either be manual checks or checks programmed with SAS on extracted data.
Electronic edit-checks will be triggered during data entry, in real-time, and will result in warning messages or queries which will appear directly on the eCRF entry forms. The site personnel will be able to answer the queries immediately or later. SAS and manual checks will be run on a batch mode, at a frequency to be agreed (e.g. weekly) and manual queries will be introduced in the eCRF accordingly. Monitors have also the possibility to generate manual queries in the EDC system.
Queries can be accessed either directly in the CRF of each subject or via a global query list.
Once answered by the investigator, the queries need to be closed by the author of the queries (manual queries issued by the monitor will be closed by the monitor, manual queries issued by the data manager and electronic queries will be closed by the data manager).