The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices.
Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events.
Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include:
Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.
"synopsis" may belong to another edition of this title.
Kate Davis is Business Development Specialist for DCRI Communications Group, Durham, NC, US.
"A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim, 2nd Edition" is a good introduction to clinical research, primarily from the site perspective. The book gives readers a solid foundation of principles and knowledge." (Journal of Clinical Research Best Practices, 8 August 2011)
"About this title" may belong to another edition of this title.
Shipping:
US$ 2.64
Within U.S.A.
Book Description Condition: New. Seller Inventory # 5848379-n
Book Description Paperback. Condition: New. 2nd Edition. Ships in a BOX from Central Missouri! Ships same or next business day. UPS shipping for most packages, (Priority Mail for AK/HI/APO/PO Boxes). Seller Inventory # 001194208N
Book Description paperback. Condition: New. Language: ENG. Seller Inventory # 9781405195157
Book Description Condition: new. Seller Inventory # FrontCover1405195150
Book Description Condition: New. PRINT ON DEMAND Book; New; Fast Shipping from the UK. No. book. Seller Inventory # ria9781405195157_lsuk
Book Description Condition: new. Seller Inventory # 23dd8920f97cc512663ef9af48ee276c
Book Description Condition: New. Seller Inventory # 5848379-n
Book Description Paperback. Condition: new. New. Fast Shipping and good customer service. Seller Inventory # Holz_New_1405195150
Book Description Paperback / softback. Condition: New. New copy - Usually dispatched within 4 working days. This second edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled. Seller Inventory # B9781405195157
Book Description Paperback. Condition: new. New. Seller Inventory # Wizard1405195150