Areas inspected | GCP inspection findings |
---|---|
Operational resources | • Delegation log incomplete or not available |
• Training records for some staff are unavailable | |
• Normal reference ranges were not updated | |
• Computer validation protocol and report were not available | |
• Trial initiation monitoring report not available | |
Trial master file | • Incomplete participant screening and enrolment log |
• Case report forms not filled completely | |
• Curriculum vitae for key staff not available | |
• Incomplete informed consent forms | |
• Contract agreements were not available | |
Conduct of the trial | • Issues with participant eligibility logs |
• Problems with participant identification logs | |
• Emergency trolley not secured and under lock and key | |
Management of trial of sponsor/CRO | • Issues with protocol deviation management |
• Quarterly progress report not available | |
• Monitoring plan not available | |
• No corrective action plan and corrective action report as a result of a monitor’s visit | |
Safety reporting | • SAEs not reported |
• Development Safety Update Reports not submitted | |
• SAEs are not processed according to the SOPs and the PBSL guideline | |
Investigational product/pharmacy | • IWRS validation report not available |
• Inadequate IP accountability | |
• Logbooks not available | |
• Pharmacy is not adequately designed and equipped. | |
Clinical data management | • Issues with data entry and verification |
Source data verification | • Problems with source data verification |
Laboratory | • Laboratory normal ranges/references not updated |
• Laboratory analytic plan not signed and endorsed | |
• Equipment qualification reports were not available | |
• Logbooks not available | |
Quality management system | • Obsolete SOPs in use |
• Quality assurance/audit report not available | |
• Some SOPs were not available | |
• SOPs and documents in a foreign language |