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
Further information is available at:
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.
On behalf of the European Compliance Academy (ECA)