FDA Publishes Guidance on Clinical Trials

At the beginning of August, the FDA released a guideline on monitoring of clinical trials. This document is the final version of a draft dated August 2011 in which a few comments have been integrated. The guideline includes for example more details about the performance of risk-based monitoring and monitoring technique. The document entitled "Guidance for Industry Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring" has a pretty wide scope and applies to both medicinal products and medical devices. With this guideline, the FDA aims to support the sponsors of clinical trials with medicinal products (chemical and biological APIs), and/ or with medical devices (Investigational Devices Exemption (IDE) studies) and/ or combination products. Patient safety is, of course, the main concern. The quality of data is also addressed. To ensure it, the sponsor has to focus - with his/ her monitoring activities - on the main aspects of the studies and the related reports. In a word, he/ she has to choose a risk-based approach. The 22-page guideline tries to describe these two main objectives.

The guideline can be found here.