Medically Significant Definition

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What is a Serious Adverse Event? | FDA

https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event

Report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or … See more

Clinically significant definition and meaning - Collins …

https://www.collinsdictionary.com/us/dictionary/english/clinically-significant

Definition of 'significant' significant (sɪgnɪfɪkənt ) Explore 'significant' in the dictionary adjective [usually ADJECTIVE noun] A significant amount or effect is large …

Significant | definition of significant by Medical dictionary

https://medical-dictionary.thefreedictionary.com/significant

sig·nif·i·cant. In statistics, denoting the reliability of a finding or, conversely, the probability of the finding being the result of chance (generally less than 5%). [L. …

Significant Definition & Meaning - Merriam-Webster

https://www.merriam-webster.com/dictionary/significant

1 : having meaning especially : suggestive a significant glance 2 a : having or likely to have influence or effect : important a significant piece of legislation also : of a noticeably or …

Guideline on good pharmacovigilance practices (GVP)

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-annex-i-definitions-rev-4_en.pdf

- Update of the definition of Signal management process as defined in GVP Module IX Rev 1, moving the previous definition into an explanatory note and addition of an explanatory …

What is medically significant in pharmacovigilance? - Quora

https://www.quora.com/What-is-medically-significant-in-pharmacovigilance

Medically significant events are those events that are not falling in any of the categories defined as serious however they are medically significant because of its outcomes. …

Clinical significance | definition of clinical significance by …

https://medical-dictionary.thefreedictionary.com/clinical+significance

clinical significance. A change in a patient’s/subject's clinical status that is regarded as important, whether or not it is due to an intervention in the context of a clinical …

Clinical Significance Examples & Purpose | What is …

https://study.com/academy/lesson/clinical-significance-definition-example.html

A treatment that is clinically significant is one whose effects are apparent enough that the associated inconveniences, costs, and harms are worth it, showing that …

ICH GCP - 1. GLOSSARY

https://ichgcp.net/1-glossary

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical …