Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4 - Revision history

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	~~== Document Information ==~~
	{{:Document:ICH ICH E8 Guideline R1 (2021)}}		{{:Document:ICH ICH E8 Guideline R1 (2021)}}

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	== ~~Text~~ ==		== Content ==
	6.1.4 Access to Interim Data		6.1.4 Access to Interim Data
	Inappropriate access to data during the conduct of the study may compromise study integrity (Sections 5.5 and 5.6 and ICH E9). In studies with planned interim analyses, special attention should be given to which individuals have access to the data and results. Even in studies without planned interim analyses, special attention should be paid to any ongoing monitoring of unblinded data to avoid inappropriate access.		Inappropriate access to data during the conduct of the study may compromise study integrity (Sections 5.5 and 5.6 and ICH E9). In studies with planned interim analyses, special attention should be given to which individuals have access to the data and results. Even in studies without planned interim analyses, special attention should be paid to any ongoing monitoring of unblinded data to avoid inappropriate access.