ICH E19 Safety Data Collection Guidelines

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E19 Safety Data Collection

E19 EWG Optimisation of Safety Data Collection

This topic was endorsed by the ICH Assembly in November 2016.

This new Guideline is proposed to provide Harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented. Recognising that protection of patient welfare during drug development is critically important, unnecessary data collection may be burdensome to patients, and serve as a disincentive to participation in clinical research.

By tailoring safety data collection in some circumstances, the burden to patients would be reduced, a larger number of informative clinical studies could be carried out with greater efficiency, studies could be conducted with greater global participation, and the public health would be better served.

The proposed Guideline would be consistent with risk-based approaches and quality-by-design principles.

Date of Step 2b: 4 April 2019

Status: Step 3 

Guidelines (Click the links below for complete guidelines)



Endorsed Documents (Click the links below for complete guidelines)





*These Guidelines Belongs to ICH website.


ICH E19 Safety Data Collection Guidelines:

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