Field QA audits and study involvement

The Study Director/Principal Investigator should ideally discuss all multi-site studies with QA personnel prior to study initiation (or prior to the issue of the protocol amendment if work is not detailed in the protocol). When acting as Study Director, a copy of the current GLP certificates should be requested from sub-contracted facilities and should be retained in QA. 

Test Facility QA personnel and test site QA personnel should sign and date QA statements detailing any monitoring that they carried out. 

Inspections should be carried out as study-specific inspections for critical phases of the study or as a batch of process inspections relating to critical tasks which are performed regularly and although may not be inspected for a specific study are inspected on a regular basis (e.g., once per month). The coordination of inspections is perhaps more difficult to predict than actually conducting the critical event. The use of local QA staff close to the sites where the field work is being conducted helps to reduce the travel time to the field sites and also the down time if the critical event cannot be made at the specified time. The use of computer planning tools to schedule fieldwork is very helpful, not only to the field staff but also to QA. 

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