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Compliance In Focus


Newest Post

Posted by John Lehmann on Wed, Mar 04, 2015

FDA Issues Guidance for IRBs

On August 27th, the FDA issued its final guidance for institutional review boards (IRBs).  The goals of this guidance are to strengthen human subject protection during clinical trials and increase the efficiency of the IRB review process.

Topics: Guidance, Institutional Review Boards, ACRO, SCRS, FDA

Posted by Brandy Chittester on Wed, Mar 04, 2015

Consent by Phone - Revisited

Several months ago, we wrote the above blog about consent by phone. Recently, I discovered the following guidance from a FAQ document:

Topics: Consent by Phone, Guidance, FDA

Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.