Data management, SOP deficiencies cited often after 2014 GCP inspections, EMA report finds
The findings come as inspectors of the EU member states performed 57 GCP inspections in 2014, which was down from the 83 conducted in 2013. The inspections were conducted relatively evenly across the globe, with 19 coming in European countries, 12 in the US, 11 in the Middle East/Asia/Pacific region and 15 elsewhere.
Of those, only about 5% in 2014 were for CROs (contract research organizations), while 63% were for clinical investigator sites and about 20% were for sponsors. The rest were tied to analytical laboratories and other clinical facilities.
Findings
Inspectors found a total of 673 deficiencies, comprising 30 critical (4%), 290 major (44%) and 353 minor (52%) for 2014. The majority of critical and major deficiencies were tied to a lack of “essential documents,” which includes documents on blood samples shipped to central labs, as well as sponsor monitoring and data management, and SOPs.
In terms of the data management issues, the report notes some examples including the use of an “inappropriate system for reporting protocol violations,” lab reports submitted late to a site, and other data management activities only undertaken after the clinical conduct of the trial was completed.
For investigator sites, EMA found deficiencies in the way adverse events were reported to a sponsor as required by a protocol, violations of inclusion criteria, and other discrepancies between source data and case report forms.
Inspections Under National Programs
In addition to the CHMP GCP inspections, 363 other inspections were conducted by national programs overseeing how clinical trials are run in EU member states.
Of those 363, 251 were for clinical investigators, 41 were for sponsors, 38 were tied to CROs, and the rest were for labs and other unspecified sites. About 15% of those inspections led to one or more critical findings, while just about half of the inspections resulted in no critical findings, but one or more major findings. The report did not go into detail about the findings.
Collaborating Inspectors
The majority of the inspections requested by the CHMP in 2014 were joint inspections involving inspectors from at least two EU member states.
In addition, the report notes that “observers from countries outside the EU have always been invited to observe the EU GCP inspections performed in those countries in the context of the centralised procedure. In 2014, out of the 38 inspections performed outside the EEA, at least 8 GCP inspections requested by the CHMP were observed by 3rd country regulatory authorities including Japan, South Korea and the USA. Three inspections were performed jointly with the USA.”
