documentation, clinical trial
- Guideline or reference source
- ICHE6(r1) Guideline for good clinical practice
- Definition
- All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
- Broader Term
- documentation
- Narrower Term
- essential documents, clinical trial
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