Kate Davis – Författare

"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 biologicsThe role and responsibilities of Institutional Review Boards, andRecent 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.

""The German word for experience - Erlebnis - the experience of the life, to live through something - underpins this book: making visible scholarly opportunities for richer and deeper contextualizations and examinations of the lived-world experiences of people in everyday contexts as they be, do and become." (Ross Todd, Preface). Information experience is a burgeoning area of research and still unfolding as an explicit research and practice theme. This book is therefore very timely as it distils the reflections of researchers and practitioners from various disciplines, with interests ranging across information, knowledge, user experience, design and education. They cast a fresh analytical eye on information experience, whilst approaching the idea from diverse perspectives. Information Experience brings together current thinking about the idea of information experience to help form discourse around it and establish a conceptual foundation for taking the idea forward. It therefore "provides a number of theoretical lenses for examining people's information worlds in more holistic and dynamic ways." (Todd, Preface)."

"The Girl Who Forgets How to Walk captures the precariousness and fragility of life" LUKE KENNARD We never speak of it, but here we know the landcan’t be trustedKate Davis writes magical realist poems born of the hills, marshes and coastal edgelands of south Cumbria. In this remarkable first collection, tarns, limekilns and abandoned pits become portals into a dark, interior world. A woman levitates above a building site; earth slips and fault-lines open up beneath the town; the sea hides ‘a gob of virus’. The moving title sequence tells the story of a young girl with polio who struggles to find her feet — and her voice — in an unforgiving landscape where ‘the ground cannot be trusted’. Alive to geology, memory and myth, The Girl Who Forgets How to Walk is a brave, uncompromising and unmissable debut.