Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including: Standard operating procedures for investigators Standard operating procedures for sponsors and CROs GCP - an indexed reference Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.
The final chapter of Frank Graham’s dynamic history of the New York Giants is entitled “With One Swipe of His Bat.” For sheer drama and a colossal slice of baseball legend, the core of that chapter cannot be topped—Bobby Thomson’s “shot heard ’round the world,” the three-run homer in the 1951 playoff series that determined that the Giants—not the Dodgers—would win the pennant. Graham, of course, starts at the beginning, 1883, the year the Giants were born. With characteristic panache, Graham tells us how it was: “This was New York in the elegant eighties and these were the Giants, fashioned in elegance, playing on the Polo Grounds. . . . It was the New York of the brownstone house and the gaslit streets, of the top hat and the hansom cab, of oysters and champagne and perfecto cigars, of [actress] Ada Rehan and Oscar Wilde and the young John L. Sullivan. It also was the New York of the Tenderloin and the Bowery.” One of fifteen team histories commissioned by G. P. Putnam’s Sons in the 1940s and 1950s, The New York Giants was first published in 1952. Some of the most colorful characters in the game pass through these pages as well as some of baseball’s brightest legends, many of whom appear in the book’s twenty-three photographs. Hall of Famers Christy Mathewson, Mel Ott, Frankie Frisch, Carl Hubbell, and Bill Terry star among the headliners in the illustrious history of the Giants. Other Hall of Famers include John McGraw, “Beauty” Dave Bancroft, “Iron Man” Joe McGinnity, Leo Durocher, Buck Ewing, Amos Rusie, John Montgomery Ward, and Ross Youngs. In his foreword, Ray Robinson gives his impression of Frank Graham: “I had been reading Graham’s warm ‘conversation pieces’ for some years, first in the New York Sun, then in the Journal-American, but I had no idea how kind and modest he was. The columnist Red Smith, Graham’s good friend, once referred to him as ‘a digger for truth, a reporter of facts . . . with an incredibly accurate ear and an implausibly retentive memory.’ To Smith, Graham was the finest sports columnist of his time.”
With family and friends in the forest of Gleigh, wee Mister Cumphobiecack chose to decree... Ostara would be a fantabulous fest to celebrate all of by which they'd been blessed. The equinox ushered in beauties of spring... and all of the joys this sweet season could bring. 'Twas also the time of the Leprechaun's Ball; which is secretly held hind a charmed waterfall. Never before has a Glumpet been asked... but this would soon change to a thing of the past!
Nowadays it is difficult to imagine an area of knowledge that can continue developing without the use of computers and informatics. It is not different with biology, that has seen an unpredictable growth in recent decades, with the rise of a new discipline, bioinformatics, bringing together molecular biology, biotechnology and information technology. More recently, the development of high throughput techniques, such as microarray, mass spectrometry and DNA sequencing, has increased the need of computational support to collect, store, retrieve, analyze, and correlate huge data sets of complex information. On the other hand, the growth of the computational power for processing and storage has also increased the necessity for deeper knowledge in the field. The development of bioinformatics has allowed now the emergence of systems biology, the study of the interactions between the components of a biological system, and how these interactions give rise to the function and behavior of a living being. This book presents some theoretical issues, reviews, and a variety of bioinformatics applications. For better understanding, the chapters were grouped in two parts. In Part I, the chapters are more oriented towards literature review and theoretical issues. Part II consists of application-oriented chapters that report case studies in which a specific biological problem is treated with bioinformatics tools.
Everyone is special in Baba Village. Mang Chee loves to run and kick his football. But sometimes he doesn't play well with others. Who will help when he loses his ball?
Critics acclaim Vol. 1 "I grew up playing sandlot baseball with Gordon in Clinton (MA) North End. I learned then to expect the unexpected from Gordon. He struck out often, but he was also always capable of hitting the long ball. His memoirs tell of that fearlessness " Leo F. McNamara, Professor of English, Emeritus, University of Michigan; Lecturer in English and Irish Studies, Queens University, Belfast and Trinity, Dublin "Graham got me all wrong in Volume 1 and I bet he'll tell more whoppers about me in Volume 2. My lawyers and I will have to buy the book to see. What a high school debate partner and college room-mate he turned out to be " Sydney H. Schanberg, 1976 Pulitzer Prize Winner for International Reporting, The New York Times, whose life experiences are portrayed in the award-winning film, "The Killing Fields" "Gordie did indeed catch me with my pants down in Volume 1. But he did at least give me credit for folding them up neatly to keep the crease " "Zip," Graham's team-mate on the undefeated Clinton Massachusetts' Galloping Gaels football team of 1950
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