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Author :
Publisher :
ISBN 13 :
Total Pages : 459 pages
Book Rating : 4.:/5 (927 download)
Download or read book Standard Operating Procedures (SAP) to Ensure Good Clinical Practice at Clinical Research Sites written by and published by . This book was released on 2007 with total page 459 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Josef Kolman
Publisher : John Wiley & Sons
ISBN 13 :
Total Pages : 214 pages
Book Rating : 4.3/5 (91 download)
Download or read book Good Clinical Practice written by Josef Kolman and published by John Wiley & Sons. This book was released on 1998 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (37 download)
Download or read book Standard Operating Procedures (SOPs) to Ensure Good Clinical Practice at Clinical Research Sites written by and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Center for Clinical Research Practice
Publisher :
ISBN 13 : 9780966359374
Total Pages : 184 pages
Book Rating : 4.3/5 (593 download)
Download or read book Standard Operating Procedures for Good Clinical Practice at the Investigative Site written by Center for Clinical Research Practice and published by . This book was released on 2001-05-01 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Thomson Center for Clinical Research Practice
Publisher :
ISBN 13 : 9781931107556
Total Pages : 345 pages
Book Rating : 4.1/5 (75 download)
Download or read book Standard Operating Procedures for Good Clinical Practice at the Investigative Site written by Thomson Center for Clinical Research Practice and published by . This book was released on 2003-05-01 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: SOPs for GCP at the Investigative Site is designed to be customized to meet the needs of you site. Each SOP can either be left as is, or altered to reflect the uniqueness of your research site. The printed template is provided in a 3-ring binder with a CD in MS Word
Author : Arna P. Shefrin
Publisher :
ISBN 13 : 9780966359312
Total Pages : 162 pages
Book Rating : 4.3/5 (593 download)
Download or read book Standard Operating Procedures for Good Clinical Practice at the Investigative Site written by Arna P. Shefrin and published by . This book was released on 1998-11-01 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Susanne Prokscha
Publisher : CRC Press
ISBN 13 : 1482239361
Total Pages : 224 pages
Book Rating : 4.4/5 (822 download)
Download or read book Writing and Managing SOPs for GCP written by Susanne Prokscha and published by CRC Press. This book was released on 2015-07-29 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focus
Author : P. Michael Dubinsky
Publisher : John Wiley & Sons
ISBN 13 : 1118949595
Total Pages : 554 pages
Book Rating : 4.1/5 (189 download)
Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
Author : Anna J. DeMarinis
Publisher :
ISBN 13 : 9781931107198
Total Pages : 290 pages
Book Rating : 4.1/5 (71 download)
Download or read book Standard Operating Procedures for Good Clinical Practice by Sponsors written by Anna J. DeMarinis and published by . This book was released on 2001 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Michael J. McGraw
Publisher : Pharmaceutical Press
ISBN 13 : 0853697906
Total Pages : 273 pages
Book Rating : 4.8/5 (536 download)
Download or read book Principles of Good Clinical Practice written by Michael J. McGraw and published by Pharmaceutical Press. This book was released on 2010 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Author : Celine Clive
Publisher : CRC Press
ISBN 13 : 9780849321818
Total Pages : 288 pages
Book Rating : 4.3/5 (218 download)
Download or read book Handbook of SOPs for Good Clinical Practice, Second Edition written by Celine Clive and published by CRC Press. This book was released on 2004-02-17 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Thomson American Health Consultants
Publisher :
ISBN 13 : 9781933040325
Total Pages : pages
Book Rating : 4.0/5 (43 download)
Download or read book Standard Operating Procedures for Good Clinical Practice as the Investigative Site written by Thomson American Health Consultants and published by . This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Thomson American Health Consultants
Publisher :
ISBN 13 : 9781933040059
Total Pages : pages
Book Rating : 4.0/5 (4 download)
Download or read book Standard Operating Procedures for Good Clinical Practice by Sponsors of Global Clinical written by Thomson American Health Consultants and published by . This book was released on 2004-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Thomson American Health Consultants
Publisher :
ISBN 13 : 9781933040240
Total Pages : pages
Book Rating : 4.0/5 (42 download)
Download or read book Standard Operating Procedures for Good Clinical Practice by Sponsors written by Thomson American Health Consultants and published by . This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Laurence Gerlis
Publisher :
ISBN 13 :
Total Pages : 79 pages
Book Rating : 4.:/5 (195 download)
Download or read book Scrip Sample Standard Operating Procedures for Good Clinical Practice written by Laurence Gerlis and published by . This book was released on 1988 with total page 79 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Gerhard Fortwengel
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805576552
Total Pages : 113 pages
Book Rating : 4.8/5 (55 download)
Download or read book Guide for Clinical Trial Staff written by Gerhard Fortwengel and published by Karger Medical and Scientific Publishers. This book was released on 2004 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.
Author : Thomson American Health Consultants
Publisher :
ISBN 13 : 9781933040448
Total Pages : pages
Book Rating : 4.0/5 (44 download)
Download or read book Standard Operating Procedures for Good Clinical Practice at the Investigative Site written by Thomson American Health Consultants and published by . This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
