Stricter Investigator Disqualification Standards Go Into Effect This Month

May 10, 2012
An FDA final rule with stronger restrictions on the work of disqualified trial investigators takes effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback. Under the tighter policy, clinical investigators deemed ineligible to test one type of investigational product — whether it is a device, human or animal drug — would also be ineligible to participate in studies supporting applications for any FDA-regulated products.
Devices & Diagnostics Letter