Reference:ICH ICH E2A Guideline 1994 III A. 2. - Revision history

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	2. Other Observations

	There are situations in addition to single case reports of "serious" adverse events or reactions that may necessitate rapid communication to regulatory authorities; appropriate medical and scientific judgement should be applied for each situation. In general, information that might materially influence the benefit-risk assessment of a medicinal product or that would be sufficient to consider changes in medicinal product administration or in the overall conduct of a clinical investigation represents such situations. Examples include:		There are situations in addition to single case reports of "serious" adverse events or reactions that may necessitate rapid communication to regulatory authorities; appropriate medical and scientific judgement should be applied for each situation. In general, information that might materially influence the benefit-risk assessment of a medicinal product or that would be sufficient to consider changes in medicinal product administration or in the overall conduct of a clinical investigation represents such situations. Examples include:
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	b. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease.		b. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease.
	c. A major safety finding from a newly completed animal study (such as carcinogenicity).		c. A major safety finding from a newly completed animal study (such as carcinogenicity).
			}}

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	}}		}}

	~~== Document Information ==~~
	{{:Document:ICH ICH E2A Guideline 1994}}		{{:Document:ICH ICH E2A Guideline 1994}}

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	== ~~Text~~ ==		== Content ==
	2. Other Observations		2. Other Observations