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Good Clinical Practice: Standard Operating Procedures for Clinical Researchers Description

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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Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic: * FDA Overview and Orientation * Introduction to GCP * Part I: General * Part II: Institutional Review Boards (IRBs) and Informed Consent * Part III: Drugs and Biologics * Part IV: Medical Devices * Part V: Manufacturing Requirements for Investigational Products * Part VI: Electronic Data Reference Tools * Part VII: Combined Glossary and Index for all Quality Guidance Documents

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%$$$ Revews Peer Review and Manuscript Management in Scientific Journals: Guidelines for Good Practice

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This comprehensive yet concise book provides a thorough and complete guide to every aspect of managing the peer review process for scientific journals. Until now, little information has been readily available on how this important facet of the journal publishing process should be conducted properly. Peer Review and Manuscript Management in Scientific Journals fills this gap and provides clear guidance on all aspects of peer review, from manuscript submission to final decision.

Peer Review and Manuscript Management in Scientific Journals is an essential reference for science journal editors, editorial office staff and publishers. It is an invaluable handbook for the set-up of new Editorial Offices, as well as a useful reference for well-established journals which may need guidance on a particular situation, or may want to review their current practices. Although intended primarily for journals in science, much of its content will be relevant to other scholarly areas.

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Completely revised and updated, the second edition of a classic reference, Handbook of SOPs for Good Clinical Practice provides templates of SOPs ready for adaptation to your requirements and immediate use. This allows you to create new SOPs or benchmark your existing SOPs against an internationally accepted set of SOPs. The book includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that you can easily customize the text to reflect your organization's processes.

The author uses language ranging from the specific to the very general, depending on the activity described and the number of the existing regulations governing the activity. This provides you with a starting point for the development of your organization's SOPs, saving you the time and money that would normally be spent researching and documenting each of the procedures described. Modifying the SOPs supplied by this book will be a much more efficient task than developing new ones from scratch.

Containing templates for SOPs and forms applicable to sponsors, study sites, and Institutional Review Boards (IRBs), Handbook of SOPs for Good Clinical Practice, Second Edition gives you the tools needed to develop effective SOPs for your organization.

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Qualitative researchers have an array of choices in how to write up their research. Yet, many write in distanced, third-person voices and give short shrift to the voices of informants, as if neither they nor their informants were part of the research. In doing so, they may believe that their writing style is scientific. Unfortunately, such styles of writing not only silence their informants and themselves, but many times they also contradict the philosophies of science on which many forms of qualitative research are based. If our philosophies of science are science, then how we write up our research, when it is consistent with our science, must logically be scientific. Grab, or writing that is both interesting and memorable, go hand-in-hand with good science.

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