Expectation based on clinical trial GCLP Audit observation and recommendations Response by the mock trial team
Preliminary interview Responsibilities and roles of all members of the trial team should be clearly written and understood The research team understood their roles and responsibility Nil
A trial team should also consist of pharmacist to manage study drugs appropriately The pharmacist was not included in the mock clinical trial team. A pharmacist would be identified for inclusion to the team
Document reviews Study regulatory binders containing the approved version of the study protocol should be always be situated at study site Regulatory binder was available at the study sites Nil
Each page of the case report forms should be signed off by the principal investigator Only the last page of the case report forms was signed off by the principal investigator Case report forms were re-designed such each page of the forms contain a section for the principal investigator signature
Facility inspection Study rooms should have well secured cabinets to ensure safety of participant data and ensure confidentiality There was no secure cabinet in the counselling/enrolment room. A secured cabinet was provided in line with the recommendation
Data storage room should have adequate security measures Access into the data storage was not restricted to only relevant personnel Additional entry restriction was placed on the data room thus limiting access.
Prerequisite study and laboratory equipment and SOP should be available for use SOP for Laboratory equipment were available  Nil
Table 1: A Simulated Audit report using NAFDAC Clinical trial GCLP checklist.