Once in the quarter the US Food & Drug Administration (FDA) issues a comprehensive list with all clinical investigators inspected and finally classified since 1977. In addition to name, address and contact details the list also comprises information on the classification, but also on deficiencies found. The list also contains addresses outside of the US. For the planning of studies with relevance for the US market the list provides an indispensable overview.

Further information is available at:
http://www.fda.gov/cder/regulatory/investigators/default.htm

Also, other interesting listings in this context are:

Adequate Assurances List for Clinical Investigators - This list contains the names of clinical investigators who have provided FDA with adequate assurances of their future compliance with requirements applicable to the use of investigational drugs and biologics.

Restricted List for Clinical Investigators - This list contains the names of all clinical investigators who have agreed to certain restrictions with respect to their conduct of clinical investigations.

Disqualified/Totally Restricted List for Clinical Investigators - This list contains the names of clinical investigators who have been disqualified or "totally restricted." FDA may disqualify a clinical investigator if he/she has repeatedly or deliberately failed to comply with all applicable regulatory requirements or the clinical investigator has submitted false information to the FDA or the sponsor.

Prepared by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)