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NIDCR Clinical Site Monitoring Guidelines by Josef Breuer is a document available to read on EtoBox.

What is NIDCR Clinical Site Monitoring Guidelines about?

This document provides guidelines for clinical site monitoring of research studies based on complexity. It defines three levels of complexity - minimal, medium, and high - and outlines the focus areas, monitoring plans, and visit schedules for each. Minimal complexity studies have the least intensive monitoring, while high complexity studies, such as phase I-III drug trials, have the most intensive monitoring, including 100% review of key documents and fields. The purpose is to ensure compliance with protoc

Author

Josef Breuer

Language

EN