Good laboratory practice study plan

All testing to support notification must be performed by methods specified in Annex V to Directive 79/831/EEC and in accordance with the principles of good laboratory practice (GLP). GLP is concerned with the organizational processes and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. 

At this stage in planning, the essential study design information listed below should be determined and a written study plan (i.e., protocol) including these key study details prepared. A formal, pre-approved study plan is required for field soil dissipation studies conducted under Good Laboratory Practice (GLP). A written study plan for non-GLP studies is highly recommended since the document serves as valuable guidance for study personnel. 

Note that good laboratory practice (glp) should not be confused with Good Laboratory Practice (GLP). The latter is the name given to a set of principles governing the organizational process and the condition under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported, and was put forward initially by the Organization for Economic Co-operation and Development (OECD) (see Chapters 2 and 9). 

Food and Drug Administration, Office of Planning and Evaluation. OPE Study 42 Results of the Nonclinical Laboratory Good Laboratory Practices Pilot Compliance Program. Sept. 1977. 

Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. 

Principal Investigator means an individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study. The Study Director s responsibility for the overall conduct of the study cannot be delegated to the Principal Investigator(s) this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable Principles of Good Laboratory Practice are followed. 

All infants in clinical trials should be characterized with regard to factors which might affect the planned outcomes. Blind randomization with respect to the allocation of test and reference formulas is important, and all studies should comply with Good Clinical and Good Laboratory Practices. 

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