Table 1. Steps in data verification and the responsible parties.
Steps in the data verification process | (Intended) result | Implementation/responsibility |
---|---|---|
1. Coordination and support | A coordinated verification process | DICA data verification department |
2. Patient and variable selection | Verification items and criteria | Data verification committee |
3. Inviting and selecting hospitals | Random sample of hospitals to audit | DICA data verification department |
4. Training of data managers | Competent data managers | DICA and scientific committee |
5. Providing patient lists and access to (E)PR | List with all patients possibly fulfilling inclusion criteria | Hospitals |
6. Providing hospital audit data on a secured laptop | A web-based survey prefilled with registered data by the hospital | MRDM |
7. Actual data verification | Results on variable level: ‘not-discrepant’ or ‘discrepant’ | Independent data managers |
8. Analysis and processing of results | Discrepancy report | DICA data verification department |
9. Interpretation and response to discrepancies | Updated discrepancy report | Hospitals |
10. Final conclusion | Final report and conclusions | Data verification committee |
(E)PR, (electronic) patient records; MRDM, medical research data management.