Good Clinical Practice Guide

Author : Cemal Cingi,Nuray Bayar Muluk
Publisher : Springer
Page : 237 pages
File Size : 48,9 Mb
Release : 2016-11-15
Category : Medical
ISBN : 9783319443447

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Quick Guide to Good Clinical Practice by Cemal Cingi,Nuray Bayar Muluk Pdf

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.

Author : Michael J. McGraw
Publisher : Pharmaceutical Press
Page : 273 pages
File Size : 40,7 Mb
Release : 2010
Category : Business & Economics
ISBN : 9780853697909

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Principles of Good Clinical Practice by Michael J. McGraw Pdf

Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.

Author : Anonim
Publisher : Stationery Office (U.K.)
Page : 0 pages
File Size : 40,8 Mb
Release : 2012-06
Category : Clinical medicine
ISBN : 0117081078

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Good Clinical Practice Guide by Anonim Pdf

Efforts to control atmospheric accumulations of greenhouse gases that threaten to heat up the planet are in their infancy. Although the IMF is not an environmental organization, environmental issues matter for the organization's mission when they have major implications for macroeconomic performance and fiscal policy. Climate change clearly passes both these tests. This volume provides practical guidelines for the design of fiscal policies (carbon taxes and emissions trading systems with allowance auctions) to reduce greenhouse gases. Not only are these instruments potentially the most effective at exploiting emission reduction opportunities in the near and longer term, but they can also generate for many countries a valuable new source of government revenue. The chapters, written by leading experts, explain the case for fiscal policies over other approaches; how these policies can be implemented; reasonable levels for emissions prices; policies for the forest sector; appropriate polic

Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Publisher : National Academies Press
Page : 217 pages
File Size : 46,5 Mb
Release : 2011-06-16
Category : Medical
ISBN : 9780309216463

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Clinical Practice Guidelines We Can Trust by Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines Pdf

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

Author : Vera Mihajlovic-Madzarevic
Publisher : John Wiley & Sons
Page : 186 pages
File Size : 49,7 Mb
Release : 2010-09-29
Category : Medical
ISBN : 9780470920886

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Clinical Trials Audit Preparation by Vera Mihajlovic-Madzarevic Pdf

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

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 42,5 Mb
Release : 2017-05-18
Category : Mathematics
ISBN : 9781315299778

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A Practical Guide to Managing Clinical Trials by JoAnn Pfeiffer,Cris Wells Pdf

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.

Author : Earl W. Hulihan,Mark P. Mathieu
Publisher : Unknown
Page : 764 pages
File Size : 49,7 Mb
Release : 2017
Category : Clinical trials
ISBN : 0996346236

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Good Clinical Practice by Earl W. Hulihan,Mark P. Mathieu Pdf

Author : OECD,World Health Organization
Publisher : OECD Publishing
Page : 128 pages
File Size : 54,8 Mb
Release : 2019-10-17
Category : Electronic
ISBN : 9789264805903

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Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies by OECD,World Health Organization Pdf

This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Author : P. Michael Dubinsky,Karen A. Henry
Publisher : John Wiley & Sons
Page : 554 pages
File Size : 50,7 Mb
Release : 2022-01-26
Category : Medical
ISBN : 9781118949597

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The Fundamentals of Clinical Research by P. Michael Dubinsky,Karen A. Henry Pdf

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

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 : Unknown
Page : 216 pages
File Size : 42,8 Mb
Release : 2012-09-17
Category : Electronic
ISBN : 0988193809

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Good Clinical Practice Guide by 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 Pdf

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.

Author : Gerhard Fortwengel
Publisher : Karger Medical and Scientific Publishers
Page : 113 pages
File Size : 48,7 Mb
Release : 2004
Category : Medical
ISBN : 9783805576550

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Guide for Clinical Trial Staff by Gerhard Fortwengel Pdf

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.

Author : MARK. ELSLEY
Publisher : Unknown
Page : 46 pages
File Size : 51,7 Mb
Release : 2017
Category : Electronic
ISBN : 191205521X

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A Guide to GCP for Clinical Data Management by MARK. ELSLEY Pdf

Author : Institute of Medicine,Committee to Advise the Public Health Service on Clinical Practice Guidelines
Publisher : National Academies Press
Page : 169 pages
File Size : 48,6 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309043465

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Clinical Practice Guidelines by Institute of Medicine,Committee to Advise the Public Health Service on Clinical Practice Guidelines Pdf

The Alberta clinical practice guidelines program is supporting appropriate, effective and quality medical care in Alberta through promotion, development and implementation of evidence-based clinical practice guidelines.

Author : Institute of Medicine,Committee on Clinical Practice Guidelines
Publisher : National Academies Press
Page : 441 pages
File Size : 42,5 Mb
Release : 1992-02-01
Category : Medical
ISBN : 9780309045896

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Guidelines for Clinical Practice by Institute of Medicine,Committee on Clinical Practice Guidelines Pdf

Guidelines for the clinical practice of medicine have been proposed as the solution to the whole range of current health care problems. This new book presents the first balanced and highly practical view of guidelinesâ€"their strengths, their limitations, and how they can be used most effectively to benefit health care. The volume offers: Recommendations and a proposed framework for strengthening development and use of guidelines. Numerous examples of guidelines. A ready-to-use instrument for assessing the soundness of guidelines. Six case studies exploring issues involved when practitioners use guidelines on a daily basis. With a real-world outlook, the volume reviews efforts by agencies and organizations to disseminate guidelines and examines how well guidelines are functioningâ€"exploring issues such as patient information, liability, costs, computerization, and the adaptation of national guidelines to local needs.

Author : Michael R. Hamrell
Publisher : Unknown
Page : 0 pages
File Size : 41,8 Mb
Release : 2013-05
Category : Clinical trials
ISBN : 0988314428

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Good Clinical Practice: A Question & Answer Reference Guide, May 2013 by Michael R. Hamrell Pdf

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