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Table 1. Sample Edit Check Specification Table
CRF | Field Name (Number) | Check Name | Edit Check | Edit Check Message |
|---|---|---|---|---|
ENROLL | Subject ID (2) | DUP_REC | Duplicate subject ID number | This subject ID number has already been assigned for this site. Please confirm correct ID number. |
DEMOG | Subject ID (2) | NO_SUBJ_ID | Missing subject ID number | A subject ID number has not been entered for this record. |
DEMOG | Subject DoB (6) | INVLD_AGE | Subject age is out of range | The date of birth value entered may be invalid. Please confirm correct date of birth. |
Hierarchical View of Edit Checks
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Table 2. Comparison of Edit Check Types
Type of check | Front-end check | Back-end check |
|---|---|---|
Missing values | X | |
Missing CRF pages | X | X |
Range checks | X | |
Checks for duplicates | X | X |
Logical inconsistencies across single CRF | X | |
Inconsistencies across CRF pages or modules | X | |
Checks of external data | X | |
Protocol violations | X | X |
Electronic Data Capture (EDC) vs. Paper-based Edit Checks
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