The regulatory landscape from the site's chair: ICH, FDA, IRB/IEC, and sponsor requirements converging on your desk
Examines how multiple regulatory frameworks generate overlapping and sometimes conflicting obligations at the site level, and how the RC reconciles them
Three versions of the same form
A sponsor sends a monitoring visit letter requesting an updated delegation log. The log must reflect the format in the sponsor's study-specific procedure: a proprietary template with 14 columns, electronic signatures, and a revision history footer. Straightforward enough. But the site's IRB requires its own delegation log format for continuing review submissions -- eight columns, wet-ink signatures, and a certification statement at the bottom that the sponsor's template does not include. And then the site's institutional policy, driven by the compliance office's interpretation of 21 CFR 312.62, mandates a third format: one that captures FTE percentages and links each delegated task to the staff member's documented training.