A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim

"The publication of the second edition of this manual comes at animportant juncture in the history of clinical research. As advancesin information technology make it possible to link individuals andgroups in diverse locations in jointly seeking the answers topressing global health problems, it is critically important toremain vigilant about moral and ethical safeguards for everypatient enrolled in a trial. Those who study this manual will bewell aware of how to ensure patient safety along with fiscalresponsibility, 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 theworld's leading academic clinical research organizations; itsmission is to develop and share knowledge that improves the care ofpatients around the world through innovative clinical research.This concise handbook provides a practical "nuts and bolts"approach to the process of conducting clinical trials, identifyingmethods and techniques that can be replicated at other institutionsand medical practices.

Designed for investigators, research coordinators, CROpersonnel, students, and others who have a desire to learn aboutclinical trials, this manual begins with an overview of thehistorical framework of clinical research, and leads the readerthrough a discussion of safety concerns and resulting regulations.Topics include Good Clinical Practice, informed consent, managementof subject safety and data, as well as monitoring and reportingadverse events.

Updated to reflect recent regulatory and clinical developments,the manual reviews the conduct of clinical trials research in anincreasingly global context. This new edition has been furtherexpanded to include:

• In-depth information on conducting clinical trials of medicaldevices and biologics
• The role and responsibilities of Institutional Review Boards,and
• Recent developments regarding subject privacy concerns andregulations.

Ethical documents such as the Belmont Report and the Declarationof Helsinki are reviewed in relation to all aspects of clinicalresearch, with a discussion of how researchers should apply theprinciples outlined in these important documents. This graphicallyappealing and eminently readable manual also provides sample formsand worksheets to facilitate data management and regulatory recordretention; these can be modified and adapted for use atinvestigative sites.