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Table 4 Common GCP inspection findings

From: Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone

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

  1. SAE serious adverse event, PBSL Pharmacy Board of Sierra Leone, IWRS Interactive Web Response System, IMP investigational medical product, SOPs standard operating procedure, GCP Good Clinical Practice