Advisor 465

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CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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separate regulations) for a product that combined a drug and a device. Investigator inspections resulted in relatively few findings overall, but an increasing focus on non-commercial sponsors is evident both from the number of inspections performed and the fact that the MHRA runs a dedicated GCP symposium day for non-commercial sponsors. CRO inspection findings Although only nine CROs (including vendors of electronic systems and niche providers of services used in clinical trials) in the UK were inspected by the MHRA in the 2017–2018 period, the metrics report includes data for 10 inspected CROs. The anomaly is the inclusion of one of the 16 non-UK inspections. This inspection was of a provider of eSystems for clinical trials, where the organisation opted to host the inspection outside the UK even though it was part of the UK risk-based domestic inspection programme. Although counted as a non- UK inspection, within the inspection report it is included in the CRO metrics. All 10 were systems

inspections and none were triggered inspections. Across the 10 inspections there were no critical findings; eight (80%) inspections had at least one major finding. Although again based on a relatively low number of inspections, these findings are favourable compared with the previous 12-month period, where there were two (25%) critical and seven (87.5%) major findings in eight CRO inspections. The total number of findings and the number of findings per inspection are shown in Table 1. Overall, inspection findings for CROs covered 22 of the 42 possible categories of inspection finding. The distribution of major inspection findings from CRO inspections is summarised in Table 2. The 28 major inspection findings fell into just 11 diferent categories. However, more than 60% were in just four categories: record keeping/ essential documents, data integrity control processes, computer systems validation and monitoring. The improvement in CRO inspection findings may indicate better sponsor–CRO trial oversight and supervision. Source:

Table 1 . CRO inspection findings (1 April 2017 to 31 March 2018).

Number of inspection findings

Mean number of findings/ inspection

Maximum number of inspection findings

Critical Major Other

0 28 58

0 2.8 5.8

0 6 9

Not applicable

Total

8.6

Table 2 . Categorisation of major CRO inspection findings (1 April 2017 to 31 March 2018).

Major findings as a percentage of all major inspection findings a