Role of study personnel

The Study Director is the pivotal person in any GLP study. The sponsor initiates the study and assigns a Study Director to act as the primary control point for all aspects of the study. The Processing Principle Investigator (PPI) acts as an agent of the Study Director and handles the processing phase of the study. The PPI reports directly to the Study Director, and quality assurance (QA) documents resulting from the processing phase are sent to the Study Director for approval. The Study Director has final say in all questions of compliance with GLP and interpretations of the protocol. The 

PPI acts as a resource to the Study Director with specific expertise in the area of food processing and acts as an extension of the Study Director in supervising of the processing phase of the study. 

The Field Principal Investigator (FPI) provides the same services to the Study Director as the PPI except that the FPFs services are provided in the area of growing crops and application of pesticides. The FPI and the PPI must interact so that information on application timing and its impact on harvest date and subsequent delivery of the RAC to the processing facility is communicated in a timely fashion. Delivery method, RAC condition, and timing are all important aspects of the processing phase that are actually controlled by the FPI. 

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