Clinical Research and GCP Update

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MHRA inspection metrics (2018)

Contract Research Organisations = 11 • 2 at same CRO • 4 (40%) had critical findings • 9 (90%) had major or critical findings

Commercial sponsors = 8 • 6 systems, 2 triggered • 4 (50%) had critical findings • 100% had major or critical finding

Investigator sites = 19 but data based on 21 (2 non-UK inspections)

• 1 (5%) had a critical finding • 13 (62%) has major finding(s) • The emphasis was on how the investigator site had been overseen by the sponsor/CRO

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Areas with most major findings!

Sponsor

CRO

• Record keeping/Essential Documents • Pharmacovigilance • QA, SOPs • Serious breach reporting • Monitoring • Oversight of trials • Data management • Data integrity • Competent authority • Insurance • Computer systems validation • Archiving

• Data integrity • Record keeping/Essential Documents • Monitoring • Quality systems/QA/SOPs • Computer systems validation • Pharmacovigilance • Serious breach reporting

• Data management • Competent authority • Contracts & agreements

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