The FDA adopted a Q&A from the International Conference on Harmonisation (IHC) to clarify the industry guidance, “E3 Structure and Content of Clinical Study Reports” (IHC E3), according to a recent article on outsourching-pharma.com. The purpose of the Q&A is to help contract research organizations (CROs) and sponsors draft clear and concise clinical study reports. The Q&A addresses various points of confusion in the 1995 IHC E3 guidance, including definitions of key terms and how to properly display adverse event data in clinical study reports. To read the full article, click here. Need help with a clinical study? Contact us at 317-899-9341.
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