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The updated ICH E 6 ( R 2 ) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The
The updated ICH ER requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a riskbased approach including which of the following?
Complete onsite documentation audits every months.
Use of the PDA cycle Plan Do Act during the annual continuing review.
Mandatory use of ICH E template Case Report Forms for all drug studies to be submitted to regulatory authorities.
Identification of study risks to determine which may safely be omitted from continual monitoring.
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