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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 which 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 practiceAn explanation of what standard operating procedures are and how they workA 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.
This book is the most informative resource for any one in clinical research. I recommend it for Investigators, clinical nurse coordinators, administrators and anyone else who deals with sponsor drug companies, IRB's and Human Subjects. I found this book to be full of every detail I needed to become a responsible and ethical clinical research nurse. It has helped me coordinate my staffs activities and resources by providing guidelines that are understandable and easily followed. With this book your research team is on the path to success!