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).
Data Cleaning
IDDI guarantees an integrated process and workflow, through the finest management of data queries generated with the use of its CDM system.
A comprehensive quality control system ensures the delivery of a clean database with a maximum degree of consistency, completeness and accuracy.
The DM team's educational background and experience, and the data management tools used at IDDI lead to fewer queries, and less time spent per patient.