Database Freeze and Database Lock
Table 1
Table
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Table 1
Table
Table 1
| Area | Readiness question |
|---|---|
| Completeness | Are expected forms and critical variables complete or explained? |
| Queries | Are critical queries closed or documented? |
| Outcomes | Are primary and secondary outcomes reviewed? |
| Safety | Are adverse events and serious adverse events reconciled? |
| External data | Are laboratory and other external datasets reconciled? |
| Duplicates | Have duplicate participants or records been resolved? |
| Coding | Are categorical codes and derived variables finalized? |
| Audit trail | Have critical late changes and deletions been reviewed? |
| Documentation | Are data dictionary, metadata, and cleaning logs complete? |
| Approval | Have PI, data manager, and statistician approved lock? |