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Failures of medical care more common at CROs, report finds

By Nick Taylor , 02-Apr-2012

Inspectors are more likely to find medical care failings at CROs than sponsors, a Health Canada report found.

The report analysed the findings of 329 clinical trial inspections done by Health Canada from 2004 to 2011. Most of the inspections took place at qualified investigator (QI) sites but the report still gives some insights into CROs (contract research organisations) and sponsors.

Observations regarding medical care and decisions made under the supervision of a QI were more common at CROs”, Health Canada wrote in its third summary of findings from GCP (good clinical practice) inspections.

In contrast Health Canada was more likely to make observations about the study protocol at the sites of QIs, which accounted for more than four-fifths of inspections, and sponsors. Overall, 10 per cent of the more than 3,000 observations made over the seven years related to protocol deviations.

Close to two-fifths of the observations were classed as major. CROs had a larger proportion of major observations, close to half, but none of the 35 critical failings. Sites with critical observations account for some of the eight per cent inspectors classed as non-compliant and took action against.

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