Good Clinical Practice Guide

Author: Medicines And Healthcare Products Regulatory Agency

Publisher: Stationery Office/Tso

ISBN: 9780117081079

Category: Medical

Page: 542

View: 1434

The Good Clinical Practice Guide is a brand new publication covering the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK. Detailed and authoritative, this guide will provide practical advice about implementing the principles of Good Clinical Practice within the context of the clinical trial regulatory framework in the European Union. Written and produced by the MHRA, this is the only guide on Good Clinical Practice available within Europe which has been produced by a regulatory agency. This title is aimed at any individual and/or organisation involved in conducting clinical trials with medicines in the UK, including both commercial and non-commercial sponsors and hosts of clinical trials, as well as contract research organisations, clinical research consultants and other niche providers. The guide references European legislation and guidance as well as international standards, so will also be relevant to organisations conducting trials across Europe and beyond
Posted in Medical

Clinical Trials Audit Preparation

A Guide for Good Clinical Practice (GCP) Inspections

Author: Vera Mihajlovic-Madzarevic

Publisher: John Wiley & Sons

ISBN: 9780470920886

Category: Medical

Page: 246

View: 1072

A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Posted in Medical

Good Clinical Practice Guide

Author: Gary L. Chadwick,David G. Forster,Cynthia M. Gates,Jamie Gault,JoAnn Giannone,Diane Paul,Deborah Rosenbaum,Carmen Wantowski,Jaime Arango,Karen Arts,Paul Braunschweiger,Karen Hansen

Publisher: N.A

ISBN: 9780988193802


Page: 216

View: 6952

The Good Clinical Practice (GCP) Guide is a logical extension of the CITI Program's web-based Good Clinical Practice (GCP) training, and is based on the CITI Program's recognized content. It is intended to serve as a quick reference guide for GCP using Drugs and Biologics as well as Devices.
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Good Clinical Practice: A Question & Answer Reference Guide

May 2011

Author: Mark P. Mathieu

Publisher: Parexel International Corporation

ISBN: 9781882615957

Category: Medical

Page: 751

View: 9482

What's new for 2011: * 60+ pages of all-new Q&As, including questions addressing emerging topics such as the use of social media in clinical trials, and the implications of IRB reviews of social media content used for patient recruitment. * A new chapter featuring exclusive interviews with Leslie Ball, M.D., director of CDER's Division of Scientific Investigations (DSI), and Joanne Less, M.D., director of FDA's Good Clinical Practice Program on the priorities and direction of the FDA's GCP enforcement programs. * Completely new and updated section featuring all the latest data and trends on the FDA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. * 200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments While continuing with a U.S./FDA focus, this innovative reference guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union, India, Latin America and Russia! Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards.With the completely updated and expanded 2011 guide, read how the FDA will now be focusing more intently on sponsors' "quality systems" when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues.In one pocket handbook, you'll have authoritative answers to hundreds of common and emerging questions, in 20+ GCP-related areas, right at your fingertips * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections, Investigational Drug Accountability, Administration, and Labeling * Now includes a new section on GCP in Latin America! * Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!
Posted in Medical

Good Clinical Practice in Assisted Reproduction

Author: Paul Serhal,Caroline Overton

Publisher: Cambridge University Press

ISBN: 9780521000918

Category: Health & Fitness

Page: 348

View: 8210

Provides an introduction to good clinical practice in the investigation and treatment of infertility, using the very latest assisted reproductive technologies. There are chapters on clinical assessment of the male and the female, followed by detailed chapters on the clinical procedures that can be put in place to help overcome infertility. There are chapters on IVF, GIFT and ZIFT and clinical aspects of PGD, and on how to set up a successful IVF Unit. With its clinical focus, this will undoubtedly become an essential introduction to this field.
Posted in Health & Fitness

GCP - A Guide to Archiving

Author: Chris Jones


ISBN: 0955765943

Category: Medical archives

Page: 54

View: 7675

This document provides guidance to all organisations (Sponsors and Investigators) that are required to retain and archive records in order to demonstrate compliance with Good Clinical Practice (GCP), and for all organisations that provide contract archive services for both electronic and physical records. Although aimed at GCP regulated organisations, the guidance and advice contained within this document might be of assistance to organisations that retain materials from other types of regulatory work, for example Good Manufacturing Practice (GMP).
Posted in Medical archives

Management of Data in Clinical Trials

Author: Eleanor McFadden

Publisher: John Wiley & Sons

ISBN: 9780470181270

Category: Mathematics

Page: 288

View: 1146

A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of "off-the-shelf" solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.
Posted in Mathematics

Quick Guide to Good Clinical Practice

How to Meet International Quality Standard in Clinical Research

Author: Cemal Cingi,Nuray Bayar Muluk

Publisher: Springer

ISBN: 3319443445

Category: Medical

Page: 237

View: 7107

This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.
Posted in Medical

Good Clinical Practice eRegs & Guides - For Your Reference Book 3

Author: eRegs & Guides

Publisher: eRegs And Guides


Category: Business & Economics

Page: N.A

View: 4045

Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: ICH Q8 Pharmaceutical Development ICH Q9 Quality Risk Management ICH Q10 Pharmaceutical Quality System
Posted in Business & Economics

Der tägliche Stoiker

366 nachdenkliche Betrachtungen über Weisheit, Beharrlichkeit und Lebensstil

Author: Ryan Holiday,Stephen Hanselman

Publisher: FinanzBuch Verlag

ISBN: 3960920717

Category: Self-Help

Page: 432

View: 3599

Wie findet man das wahre Glück? Wie lässt sich Erfolg wirklich bemessen? Und wie geht man mit den Herausforderungen des Alltags wie Wut, Trauer und der Frage nach dem Sinn des Ganzen um? Was große Geister wie George Washington, Friedrich der Große, Weltklassesportler oder Top-Performer längst für sich entdeckt haben, liegt mit "Der tägliche Stoiker" erstmals gesammelt vor. New York Times-Bestsellerautor Ryan Holiday und Stephen Hanselman haben das Wissen der Stoiker in 366 zeitlose Lektionen verpackt und zeigen, dass die Philosophie des Stoizismus nicht nur zeitlos, sondern gerade für unsere hektische und unsichere Zeit ein Segen ist. Weisheit, Mut, Gerechtigkeitssinn und Selbstbeherrschung sowie Gelassenheit lassen sich erlernen und helfen uns, in der zunehmenden Komplexität unserer Welt zu bestehen. Die uralten Weisheiten der Stoiker, gesammelt und kommentiert, unterstützen bei diesen alltäglichen Herausforderungen.
Posted in Self-Help

Winter in Madrid


Author: C. J. Sansom

Publisher: Heyne Verlag

ISBN: 3641226503

Category: Fiction

Page: 736

View: 9959

1940: Nach dem Bürgerkrieg liegt Madrid in Ruinen. In diesen unsicheren Zeiten erhält der britische Kriegsveteran Harry Brett einen schwierigen Auftrag: Er soll in Madrid Kontakt mit seinem Jugendfreund Sandy aufnehmen, der angeblich den Diktator Franco unterstützt. Harry findet in Madrid nicht nur eine Welt des Kampfes um Menschlichkeit vor, sondern gerät in den Bann einer großen, tragischen Liebe ...
Posted in Fiction

A Comprehensive and Practical Guide to Clinical Trials

Author: Delva Shamley,Brenda Wright

Publisher: Academic Press

ISBN: 0128047305

Category: Medical

Page: 210

View: 8442

A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank
Posted in Medical

Practical Guide to Clinical Data Management

Author: Susanne Prokscha

Publisher: CRC Press

ISBN: 9781420007886

Category: Medical

Page: 256

View: 7821

The management of clinical data, from its collection to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today. Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition include - A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures Practices for both electronic data capture (EDC)-based and paper-based studies A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task. Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.
Posted in Medical

Good Clinical Practice: A Question & Answer Reference Guide, May 2013

Author: Michael Hamrell

Publisher: N.A

ISBN: 9780988314429

Category: Medical

Page: N.A

View: 9853

Featuring An All-New Index of Topics! This industry-leading GCP training and reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials. And, in response to popular demand, the 2013 edition features an all-new index, making topic research easier than ever before. The completely updated and expanded 2013 guide includes: Input from an Expert Advisory Panel including distinguished international GCP experts who have assured that the book contains the most current and up-to-date information on global GCP requirements. Over 100 new Q&As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials, and new changes and information to be provided in informed consent documents. Revisions and updates to the section on HIPAA and privacy on this tenth anniversary of the implementation of the law. Updated information on electronic records and use of EMR in clinical research. Completely updated sections featuring all the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. 200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments. Revised and updated sections on GCP compliance and clinical trial requirements in numerous regions of the world outside the US. Updates to information on Latin America, India, Russia, Ukraine, and China, and the addition of GCP information for Canada. Read how the FDA is focusing more intently on sponsors' quality systems when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. About Barnett's GC
Posted in Medical

Clinical Pain Management , A Practical Guide

Medicine, Medicine

Author: CTI Reviews

Publisher: Cram101 Textbook Reviews

ISBN: 1467222364

Category: Education

Page: 83

View: 4029

Facts101 is your complete guide to Clinical Pain Management , A Practical Guide. In this book, you will learn topics such as as those in your book plus much more. With key features such as key terms, people and places, Facts101 gives you all the information you need to prepare for your next exam. Our practice tests are specific to the textbook and we have designed tools to make the most of your limited study time.
Posted in Education

Phase I Cancer Clinical Trials

A Practical Guide

Author: Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse

Publisher: Oxford University Press

ISBN: 0199359032

Category: Medical

Page: 352

View: 4649

Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials
Posted in Medical

Regulated Bioanalytical Laboratories

Technical and Regulatory Aspects from Global Perspectives

Author: Michael Zhou

Publisher: John Wiley & Sons

ISBN: 9780470922804

Category: Science

Page: 528

View: 8031

This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.
Posted in Science

Good Clinical, Laboratory and Manufacturing Practices

Techniques for the QA Professional

Author: Phillip A. Carson,Nigel J. Dent,Royal Society of Chemistry (Great Britain)

Publisher: Royal Society of Chemistry

ISBN: 0854048340

Category: Science

Page: 622

View: 1267

Spanning chemical, cosmetic and manufacturing industries, this book is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists.
Posted in Science

The Fast Diet - Das Original

5 Tage essen, 2 Tage fasten -

Author: Dr. Michael Mosley,Mimi Spencer

Publisher: Goldmann Verlag

ISBN: 3641131049

Category: Cooking

Page: 224

View: 1212

Der Megatrend der 5:2-Diäten sorgt in England bereits ordentlich für Wirbel. "The Fast Diet" ist das Buch, das den Hype auslöste - das Original. Das Konzept ist bestechend einfach: Man legt zwei Fastentage in der Woche ein, an denen die Kalorienzufuhr heruntergefahren wird. An den restlichen fünf Tagen isst man ganz normal. Die Ergebnisse sind erstaunlich: Die Kilos purzeln, durch die gesunde Lebensweise wird das Risiko von Diabetes, Herzerkrankungen und Krebs verringert. Eine Diät, wie sie sich jeder wünscht, der abnehmen möchte: simpel, fundiert, effektiv und gesund!
Posted in Cooking