E6 ich e6 gcp 121 - Study guides, Class notes & Summaries
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CCRP SOCRA Study test in depth Examination and 100% correctly verified Solutions Latest version 2024/2025
- Exam (elaborations) • 59 pages • 2024
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CCRP SOCRA Study test in depth Examination and 100% correctly verified Solutions Latest version 2024/2025 
 
Clinical Safety constitutes what ICH efficacy guidelines? - correct answer E1-E2F 
 
Good Clinical Practice constitutes what ICH efficacy guidelines? - correct answer E6 
(ICH E6 GCP 1.21) 
 
What is the legal status of the International Committee on Harmonization? - correct answer While several countries have adopted ICH guidelines as laws, the US FDA adopted ICH only as guidance. The...
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