eClinical trial
Glossaries
| Term | Definition |
|---|---|
| eClinical trial |
Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between studies and trials. Both words refer to systematic efforts to obtain evidence relevant to regulatory authorities, but, depending on regulatory context and particularly in the case of postmarketing commitments, a study might not be the appropriate word for a clinical trial (prospective, controlled, randomized), but should be reserved instead for surveillance, structured gathering of information, epidemiological studies, or even animal studies [Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. See also clinical study, clinical trial.
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Synonyms:
eClinical investigation; eClinical study |
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