trustworthy (electronic records)
Glossaries
| Term | Definition |
|---|---|
| trustworthy (electronic records) |
An attribute of records (data and documents) and signatures submitted to regulatory agencies referring to their suitability for making scientific findings of safety and efficacy that underlie public policy decisions pertaining to market authorization. Two key dimensions that determine the trustworthiness of eClinical trial data are data quality and data integrity. [after 21CFR Part 11]
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