A Clinical Trials Manual From The Duke Clinical Research Institute (ePub)

"The publication of the second edition of this manual comes at an
important juncture in the history of clinical research. As advances
in information technology make it possible to link individuals and
groups in diverse locations in jointly seeking the answers to
pressing global health problems, it is critically important to
remain vigilant about moral and ethical safeguards for every
patient enrolled in a trial. Those who study this manual will be
well aware of how to ensure patient safety along with fiscal
responsibility, trial efficiency, and research integrity."

--Robert Harrington, Professor of Medicine, Director,
Duke Clinical Research Institute, Durham, North Carolina, USA

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:

* In-depth information on conducting clinical trials of medical
devices and biologics

* The role and responsibilities of Institutional Review Boards,
and

* Recent developments regarding subject privacy concerns and
regulations.

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.