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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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This practical, highly focused book is intended to be an authoritative planning and management reference for anyone associated with capital projects or facility operations involving biocontainment facilities for research on potentially dangerous biological pathogens and toxins. The emphasis is on research facilities that are designed to operate at biosafety containment Levels 3 or 4, which in the U.S. is designated BSL-3 or BSL-4 as defined by the CDC and NIH. Level 3 and 4 biocontainment is referred to in this book as high-containment. The book is directed especially to people of all disciplines who are new to high-containment; to managers or program leaders undertaking new initiatives to expand, build new, or modernize high-containment facilities; to administrators who need a clear picture of the level of institutional commitment that high-containment facilities entail; and to veterans in the field who have yet to codify their thinking on the elements of their successes or possibly even failures.
This is not a book about design details, specific floor plans, or detailed procedural protocols. Nor is it about science facilities in general. Rather, it is about the management of capital projects and operational programs that have specific high-containment program elements.
This book distills and codifies the experience, insights, and lessons learned of seasoned practitioners (facility planners, project directors, owners, end users, science program managers, and facility operators) who are immersed in the field of high-containment facility planning, construction, operation, and program management. They have experienced at first-hand the remarkable advancement that has occurred in the ten-year period 2002-2012 in the thinking and practice of delivering and operating safe environments for research involving dangerous biological pathogens and toxins. They share their management experiences, insights, and lessons learned in the form of 55 management principles for developing and operating successful high-containment facilities, important background information, personal testimonies and counsel, and guidelines and templates for planning and operations.
The management principles put forth in this book come in two types: Normative Principles (things to do or not to do), and Descriptive Principles (if you do or don't do this, expect the following outcome). It is intended that these principles will spur productive discussion among future project and management team members to shape successful project and management outcomes.
Appendices list all 55 of the book's management principles and a glossary of terminology pertaining to high-containment facilities.
The ten-year period – 2002 to 2012 – represents the most active, aggressive, and well-funded decade of high-containment facility growth in history. In this decade, major biocontainment laboratory facilities have been built or have undergone major upgrades in North America, Europe, Asia, Australia, and Africa, and hundreds of research universities and hospitals, government research agencies, private sector biopharmaceutical firms, diagnostic companies, and research institutes have completed or are currently modernizing or putting in place new facility capacity for high-containment research programs. Many of these facilities have now accumulated significant start-up, commissioning, and operational experience, which this book seeks to codify and chronicle for the benefit of future high-containment research programs.
All book royalties received by Tradeline are being donated to biocontainment facility operations training programs in Africa to offset the costs of visiting subject area experts who conduct special training courses in high-containment facilities management, maintenance, and operations.

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Best How to Grow Your Investigative Site: A Guide to Operating and Expanding a Successful Clinical Research Center

How to Grow Your Investigative Site: A Guide to Operating and Expanding a Successful Clinical Research Center by CenterWatch




How to Grow Your Investigative Site is an ideal resource for experienced clinical investigators interested in expanding their clinical trials operations in order to establish a more successful and effective research enterprise. Written by Barry Miskin, MD with Ann Neuer, this book is filled with practical tools, worksheets and contracts, tips and instructions.

Developed in accordance with the essentials and standards of the ACCME, this guidebook provides up to 4.0 hours in category 1 credit. An exam is provided online.

Book features:
- Identifying and retaining clinical research coordinators and study support staff
- Managing investigative site financials
- Negotiating budgets and contracts
- Expanding operations and infrastructure
- Filling your pipeline with more research grantsRead more How to Grow Your Investigative Site: A Guide to Operating and Expanding a Successful Clinical Research Center

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Clinical Research Coordinator Handbook, Fourth Edition