.svg){kind=icon}
On 8/29/2011, the FDA issued a Draft Guidance recommending changes to monitoring practices in clinical trials. The earlier 1988 Guidance recently was withdrawn and building on the spirit of ICH E6 (1996), the FDA recognizes the desirability of increased monitoring flexibility in a world where technological tools have become available. The Guidance suggests that a risk-based approach tailored for the specific study can best achieve protection of human subjects, maintain data integrity, and comply with regulations.
The FDA is accepting electronic or written comments on the draft until November 28, 2011. To view the Guidance, click here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf
.svg "white RQM logo")
