Source Documents and Source Data Verification
Table 1
Table
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Table 1
Table
Table 1
| Database field | Possible source document | Verification concern |
|---|---|---|
| Consent status | Signed consent form or consent log | Confirm consent before study procedures |
| Enrollment date | Enrollment CRF or clinic note | Confirm participant entered study on correct date |
| Temperature | Vital signs chart or direct eCRF entry | Confirm unit and measurement time |
| Hemoglobin result | Laboratory report or laboratory system export | Confirm value, unit, date, and participant ID |
| Treatment dispensed | Pharmacy log or medication administration record | Confirm drug name, dose, and date |
| Adverse event | Clinical note, AE form, participant report | Confirm event description, seriousness, and outcome |
| Follow-up status | Follow-up phone log or clinic attendance record | Confirm outcome and date of assessment |