Health Canada: Nearly One-in-ten Trials Inspected Noncompliant
Posted 29 March 2012 | By
Health Canada released an updated document Wednesday (28 March) detailing the results of all clinical trial inspections conducted by the agency between 1 April 2004 and 31 March 2011, showing 8% of all clinical trials inspected by Health Canada to be noncompliant with Canadian regulations.
The update is the third since the launch of the program, and is intended to "increase awareness of Canadian regulatory requirements within the clinical research community, while maintaining the confidentiality and privacy of those involved in the inspections," said Health Canada in a statement.
The document covers 329 inspections conducted over the seven year period. The majority of all inspections took place at sites controlled by qualified investigators (QIs), while a further 27 trials were conducted by sponsors and 14 were conducted by contract research organizations (CROs). A further 31 ethics boards were investigated during the 2004-2008 period.
Of the inspections conducted, 92% were found to be compliant, while the remaining 8% were found to be noncompliant. 3,148 observations of noncompliance were noted by investigators. 54% of noncompliant observations were found to be minor, 39% major and 6% unclassified notes.
Health Canada - Summary Report of Inspections of Clinical Trials Conducted from April 2004 to March 2011