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The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies - PharmaFacts
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The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies

Guidances - OECD Guidances

It is becoming increasingly common for non-clinical health and environmental safety studies to be conducted at more than one site. For example, companies may use facilities which specialise in different activities located at sites in various countries; or field trials on agrochemicals may have to be conducted on different crops or soil types located in different regions or countries. Toxicology studies may also have phases of the study conducted by different departments of the same organisation or different companies.

In the framework of the second OECD Consensus  Workshop on Good Laboratory Practice, held 21st – 23rd May 1991, in Vail, Colorado, experts discussed and reached consensus on the application of the GLP Principles to field studies. An OECD Consensus Document on “The Application of the GLP Principles to Field Studies” was subsequently published in 1992 and revised in 1999 [ENV/JM/MONO(99)23]. Among other aspects, this document introduced the concept of a “Principal Investigator” who could assume delegated responsibility for a phase of a field study being conducted at a test site that was remote from the Study Director. Although the concept of a Principal Investigator had originally been developed to assist in the conduct of field studies that included trials being conducted at several different locations, the concept is equally applicable to any other type of multi-site study.

The_Application_of_the_OECD_Principles_of_GLP_to_the_Organisation_and_Management_of_Multi-site_Studies.pdf