source data, clinical
- Guideline or reference source
- ICHE6(r1) Guideline for good clinical practice
- Definition
- All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
- Broader Term
- source data
- Related Term
- source documents, clinical
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