Communication - Quality Assurance, The Principal Investigator and Management
The Study Director should also communicate effectively with Quality Assurance personnel as required during the conduct of the study, ensuring independent inspections are being carried out and any Good Laboratory Practice compliance risks to the study noted are addressed.
Where a study is multi-site, effective communication is vital, especially between the Study Director and Principal Investigators.
Principal Investigators operate remotely from the Study Director, and may act autonomously within their phase of the study. However, the overall aims of the study may be compromised if local decisions are made without the oversight and authorisation of the Study Director.
Click here to see the Good Laboratory Practice requirements on multi-site studies...
Regular contact between the Study Director and Principal Investigator is often the key to a successful multi-site studies.
OECD Principles of Good Laboratory Practice state that:
In a multi-site study, test facility management is responsible for ensuring that clear lines of communication exist between the Study Director, Principal Investigator, the Quality Assurance Programmes and study personnel