Addendum to Guideline for Good Clinical Practice (GCP) Now in Effect

Published on 27/06/2017

The Guideline for good clinical practice E6(R2) Step 5 was adopted by the European Medicines Agency (EMA) on 14 June 2017. It includes an addendum, which was introduced mainly to cope with new electronic technologies now largely used in clinical trials, with data integrity rules and risk-based management of the trials.

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