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Good Clinical Practice: Standard Operating Procedures for Clinical Researchers
 
 
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Good Clinical Practice: Standard Operating Procedures for Clinical Researchers [Paperback]

Josef Kolman (Editor), Paul Meng (Editor), Graeme Scott (Editor)
5.0 out of 5 stars  See all reviews (1 customer review)

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Book Description

May 15, 1998 0471969362 978-0471969365
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 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 practice
* An explanation of what standard operating procedures are and how they work
* A selection of actual standard operating procedures and checklists
This 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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Good Clinical Practice: Standard Operating Procedures for Clinical Researchers + SOP Workshop: Workshop in a Book on Standard Operating Procedures for Biotechnology, Health Science, and Other Industries + How to write standard operating procedures and work Instructions.: A handbook For Quality Managers and Quality Engineers.
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Editorial Reviews

From the Publisher

There is a need for researchers in the pharmaceutical industry to adopt a more formal approach to the procedures they apply to the various stages of their clinical trial work. This book covers all of the relevant areas in standard operating procedures within the drug discovery field. The text is organized in a logical sequential order complete with helpful checklists designed to develop a useful set of standard operating procedures.

From the Back Cover

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 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 practice
* An explanation of what standard operating procedures are and how they work
* A selection of actual standard operating procedures and checklists
This 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.

Product Details

  • Paperback: 177 pages
  • Publisher: Wiley (May 15, 1998)
  • Language: English
  • ISBN-10: 0471969362
  • ISBN-13: 978-0471969365
  • Product Dimensions: 9.6 x 7.7 x 0.5 inches
  • Shipping Weight: 9.6 ounces (View shipping rates and policies)
  • Average Customer Review: 5.0 out of 5 stars  See all reviews (1 customer review)
  • Amazon Best Sellers Rank: #1,005,702 in Books (See Top 100 in Books)

 

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24 of 25 people found the following review helpful:
5.0 out of 5 stars A Must Have For Clinical Researchers, June 27, 2000
This review is from: Good Clinical Practice: Standard Operating Procedures for Clinical Researchers (Paperback)
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!
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Inside This Book (learn more)
First Sentence:
These Standard Operating Procedures (SOPs) for Investigators have been written for the use of doctors and their staff performing clinical research in hospitals and general practice. Read the first page
Key Phrases - Capitalized Phrases (CAPs): (learn more)
Ethics Committee, Principal Investigator, Investigator's Brochure, Study File, Other Related Procedures, Date of Protocol, Abbreviated Title, Protocol Code, Sponsor Name, Good Clinical Practice, Signature Date, Standard Operating Procedures, Study Site Co-ordinator, Declaration of Helsinki, Medicinal Products, Enrol Procedure
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