Comparative Analysis for Non-IND Sites Advarra Consulting provides in-depth analysis of German, European, and US regulations, allowing a cancer research study to move forward. The Challenge In 2018, German regulatory authorities suddenly announced that German sites should participate in clinical trials as non-IND sites. The rationale for this change is that when an investigator signs the FDA’s required Statement of Investigator (Form FDA 1572), he or she commits to full compliance with applicable US laws, without exception. However, discrepancies exist between US, German, and European legal requirements. The German authorities noted that local requirements must take precedence despite the commitments on the 1572. An exception was provided: A German site may proceed as an IND site i

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