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Guideline for good clinical practice E6(R2)

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harmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product

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WHO/BS/2017.2311 Page 6 of 76 1 legal status of investigational products varies from country to country and should therefore be 2 discussed with the NRA.