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International Council for Harmonisation E6(R2) addendum: Challenges of implementation
1Consultant - Clinical Research and Development, Mumbai, Maharashtra, India.
Abstract:
The International Council for Harmonisation (ICH) E6 - good clinical practice (GCP) (R2) addendum - was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches - quality management system, risk-based monitoring with emphasis on human subject protection, and data integrity. The article discusses challenges in adoption and implementation of the changes in ICH GCP guideline for clinical trial stakeholders.
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