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Description
Study directors appointed by testing facility managers for non-clinical laboratory studies can use this template to comply with the final report requirement of Good Laboratory Practice (GLP) regulations. Based on both FDA regulation and OECD principles, this template can be used to do the following:
- Note changes in and deviations from the study plan or protocol,
- Summarize, present, evaluate, and discuss the results of the study,
- Describe circumstances that may have affected the quality or integrity of the data,
- Identify the locations where the study plan or protocol, samples of test and reference items, specimens, raw data, and the final report are to be stored, and
- Add the GLP Compliance Statement and the Quality Assurance Statement.
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