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Author: Josef Kolman, Paul Meng, Graeme Scott
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Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC – Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC – Dr. Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures that are designed to be used as ‘working tools’ within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include* A brief description of the history and development of clinical research and good clinical practice* An explanation of what standard operating procedures are and how they work* A selection of actual standard operating procedures and checklistsThis well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.
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