Search results for: good-clinical-practice-guide

Good Clinical Practice Guide

Author : Medicines And Healthcare Products Regulatory Agency
File Size : 42.67 MB
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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

Quick Guide to Good Clinical Practice

Author : Cemal Cingi
File Size : 65.66 MB
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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.

Good Clinical Practice A Question Answer Reference Guide

Author : Mark P. Mathieu
File Size : 84.71 MB
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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!

Documentation of Clinical Trial Monitoring

Author : Edyta Niebrzegowska
File Size : 76.74 MB
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This concise e-book provides clinicians as well as administrative personnel involved in clinical research with an understanding of documentation related to clinical trial monitoring activities at each stage of the study from planning and set up, through conduct and close-out.

Practical Guide to Clinical Data Management

Author : Susanne Prokscha
File Size : 59.4 MB
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Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications. With the tools this book provides, you'll learn how to: Ensure that your DMB system is in compliance with federal regulations Build a strategic data management and databsing plan Track and record CRFs Deal with problem data, adverse event data, and legacy data Manage and store lab data Identify and manage discrepancies Ensure quality control over reports Choose a CDM system that is right for your company Create and implement a system validation plan and process Set up and enforce data collection standards Develop test plans and change control systems This book is your guide to finding the most successful and practical options for effective clinical data management.

Guide for Clinical Trial Staff

Author : Gerhard Fortwengel
File Size : 45.11 MB
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The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.

Using Clinical Practice Guidelines to Evaluate Quality of Care

Author :
File Size : 40.70 MB
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Guide to Good Clinical Practice

Author : Mary Bernadette Ott
File Size : 52.44 MB
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A Comprehensive and Practical Guide to Clinical Trials

Author : Delva Shamley
File Size : 89.89 MB
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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

Good Clinical Practice

Author : Munish Mehra
File Size : 41.44 MB
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A Practical Guide to Managing Clinical Trials

Author : JoAnn Pfeiffer
File Size : 61.39 MB
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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

Good Clinical Laboratory and Manufacturing Practices

Author : Phillip A. Carson
File Size : 38.66 MB
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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.

Clinical Trials Audit Preparation

Author : Vera Mihajlovic-Madzarevic
File Size : 31.68 MB
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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

GCP A Guide to Archiving

Author : Chris Jones
File Size : 59.29 MB
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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).

Good Clinical Practice in Assisted Reproduction

Author : Paul Serhal
File Size : 63.52 MB
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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.

Regulated Bioanalytical Laboratories

Author : Michael Zhou
File Size : 63.44 MB
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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.

Atreya s guide to Ayurveda Practice

Author : Vaidya Vasant Patil
File Size : 89.56 MB
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Ayurveda, the science of life, holistic medicine offers a complete solution with medicines, diet and lifestyle. The radical shift occurred in defining health encourages the medical fraternity of modern times to look deeply into empirically evolved ayurvedic techniques for the maintenance of positive health. The recent WHO report says that 70% of the world population is using herbal medicines for their primary health care. In last decade the use of herbal medicines increased tremendously. Safe and effective prescribing is a basis of proper patient care. Many pocket books or practical prescriber available for allopathic medicine in market but very few for Ayurveda. In order to fulfill this we have undertaken this task. In order to diagnose the disease on the basis of Ayurvedic principles, the physician should have to work very hard to know the subtle changes occurring inside the body due to the imbalance of Dosha. To become perfect in Ayurvedic diagnosis, the physician needs to understand Dosha Vikalpa (Dravyataha-Gunataha-Karmataha Vriddhi of Dosha), Dhatu Vaishamya (the quantum of vitiation, the status of Dhatu & Srotas), Agni Sthiti and nature of Ama. It is essential to get the practical training from the Guru (Teacher) in order to become perfect in Ayurvedic diagnosis, as evidenced from the Vagbhata’s citation “The proficiency comes by continuous practice just like the the genuineness of diamond etc. can’t be known by mere reading of books”. The fundamental principles for treating any disease are Bio-purification, Palliative medicine and avoiding the causative factors. Considering this, the author tried to incorporate these triad principles of treatment. For every diseases, there is explanation regarding causes, symptoms, diagnosis, prognosis, line of treatment, Panchakarma treatment, Palliative treatment, formulations, Prescriptions, Pathyaapathya. I hope the Vaidyas will become efficient by practicing the remedies, regime and diet described in this book.

Phase I Cancer Clinical Trials

Author : Elizabeth A. Eisenhauer
File Size : 43.55 MB
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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

Clinical Practice Guidelines in Mental Health

Author : Paula Whitty
File Size : 22.27 MB
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This is a description of the important lessons to be learnt from first-hand experience of those who develop, evaluate and use the growing portfolio of guidelines in mental health. The book considers the potential benefits and harms of clinical practice guidelines and methods of development and implemetation.

Clinical Trials in Neurology

Author : Roberto Guiloff
File Size : 66.17 MB
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Clinical Trials in Neurology comprehensively tackles the methodology and design of clinical trials in neurological disease. A general section deals with the ethical aspects, drug development and regulatory requirements, basic trial designs and the statistics used. A diseases section tackles specific aspects of disorders, focusing on the relevant ethical issues, outcome variables and experience with large multicentre trials.