Sources of Data Quality Problems
Table 1
Table
6 / 7
Table 1
Table
Table 1
| Source | Example problem | Prevention strategy |
|---|---|---|
| Protocol ambiguity | Outcome definition unclear | Resolve during protocol review and document definitions |
| CRF design | Missing units for laboratory values | Include units in labels and validation rules |
| Database setup | Branching logic hides required fields incorrectly | Test scenarios before production |
| Site workflow | Delayed entry after visits | Define entry timelines and monitor lag |
| Source documents | Clinical notes incomplete | Train staff and clarify source documentation expectations |
| External data | Lab file uses different IDs | Data transfer agreement and reconciliation |
| Human error | Digits transposed during entry | Validation ranges and source verification |
| Access control | Shared accounts obscure audit trail | Individual accounts and user training |