WebbIs there a reasonable possibility the adverse event is related to study treatment? 「いいえ」の場合、この有害事象のもっとも可能性が高い原因は何ですか? (1つにだけ … Webb1 okt. 2024 · It is the sponsor’s responsibility to determine whether an event is unexpected, the FDA explained. “FDA interprets reasonable possibility to mean there is evidence to suggest a causal relationship between the drug and the adverse event,” the FDA noted in its guidance to investigators.
FDA drafts safety reporting guidance for drug and device ... - RAPS
Webb2 dec. 2012 · 相当因果関係のある現実 English translation: Damage to the other party which is equally correlated to and was actually caused by this. 08:09 Dec 2, 2012 … WebbA relevant assertion is a financial statement assertion that has a reasonable possibility of containing a misstatement or misstatements that would cause the financial statements to be materially misstated. The determination of whether an assertion is a relevant assertion is based on inherent risk, without regard to the effect of controls. A10. halestorm 2021 tour
Q17:治験における有害事象の因果関係判定や報告基準において、
Webb論理的可能性を英語で訳すと reasonable possibility - 約1552万語ある英和辞典・和英辞典。 発音・イディオムも分かる英語辞書。 論理的可能性: reasonable possibility WebbA17: ICH-E2Aでは、「合理的な可能性(Reasonable Possibility)」による因果関係判定と、「因果関係を否定 できないこと(Causal Relationship Cannot Be Ruled Out)」による因果関係判定という2つの考え方が述 べられており、どちらに重きを置くかが日米欧 … WebbIn determining whether it is probable, reasonably possible or remote that a liability will be incurred, we consider, among other things: (a) the nature of the litigation, claim, or assessment; (b) the progress of the matter; (c) the opinions or views of legal counsel and other advisors; (d) our experience in similar matters; (e) any decision by … bumble bees favorite plants