Good Clinical Practice

Author : Cemal Cingi,Nuray Bayar Muluk
Publisher : Springer
Page : 237 pages
File Size : 42,6 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 : 41,6 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 : Vera Mihajlovic-Madzarevic
Publisher : John Wiley & Sons
Page : 186 pages
File Size : 44,7 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 : Earl W. Hulihan,Mark P. Mathieu
Publisher : Unknown
Page : 764 pages
File Size : 53,6 Mb
Release : 2017
Category : Clinical trials
ISBN : 0996346236

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

Author : Anonim
Publisher : Stationery Office (U.K.)
Page : 0 pages
File Size : 49,8 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 : Josef Kolman,Paul Meng,Graeme Scott
Publisher : John Wiley & Sons
Page : 214 pages
File Size : 44,8 Mb
Release : 1998
Category : Medical
ISBN : UOM:39015040166947

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Good Clinical Practice by Josef Kolman,Paul Meng,Graeme Scott Pdf

Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * An explanation of what standard operating procedures are and how they work * A selection of actual standard operating procedures and checklists This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.

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 : 44,6 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 : P. Michael Dubinsky,Karen A. Henry
Publisher : John Wiley & Sons
Page : 554 pages
File Size : 55,9 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 : World Health Organization
Publisher : Unknown
Page : 125 pages
File Size : 55,9 Mb
Release : 2005
Category : Clinical medicine
ISBN : 924159392X

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Handbook for Good Clinical Research Practice (GCP) by World Health Organization Pdf

Author : Celine Clive
Publisher : CRC Press
Page : 288 pages
File Size : 47,7 Mb
Release : 2004-02-17
Category : Medical
ISBN : 0849321816

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Handbook of SOPs for Good Clinical Practice, Second Edition by Celine Clive Pdf

Completely revised and updated, the second edition of a classic reference, Handbook of SOPs for Good Clinical Practice provides templates of SOPs ready for adaptation to your requirements and immediate use. This allows you to create new SOPs or benchmark your existing SOPs against an internationally accepted set of SOPs. The book includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that you can easily customize the text to reflect your organization's processes. The author uses language ranging from the specific to the very general, depending on the activity described and the number of the existing regulations governing the activity. This provides you with a starting point for the development of your organization's SOPs, saving you the time and money that would normally be spent researching and documenting each of the procedures described. Modifying the SOPs supplied by this book will be a much more efficient task than developing new ones from scratch. Containing templates for SOPs and forms applicable to sponsors, study sites, and Institutional Review Boards (IRBs), Handbook of SOPs for Good Clinical Practice, Second Edition gives you the tools needed to develop effective SOPs for your organization.

Author : Mindy J. Allport-Settle
Publisher : Pharmalogika
Page : 750 pages
File Size : 50,6 Mb
Release : 2010-10-03
Category : Clinical trials
ISBN : 0982147686

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Good Clinical Practice by Mindy J. Allport-Settle Pdf

Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic: * FDA Overview and Orientation * Introduction to GCP * Part I: General * Part II: Institutional Review Boards (IRBs) and Informed Consent * Part III: Drugs and Biologics * Part IV: Medical Devices * Part V: Manufacturing Requirements for Investigational Products * Part VI: Electronic Data Reference Tools * Part VII: Combined Glossary and Index for all Quality Guidance Documents

Author : MARK. ELSLEY
Publisher : Unknown
Page : 46 pages
File Size : 53,8 Mb
Release : 2017
Category : Electronic
ISBN : 191205521X

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

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 : 41,5 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 : Philip Carson,Nigel Dent
Publisher : Royal Society of Chemistry
Page : 656 pages
File Size : 48,5 Mb
Release : 2007-10-31
Category : Science
ISBN : 9781847557728

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Good Clinical, Laboratory and Manufacturing Practices by Philip Carson,Nigel Dent Pdf

Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.

Author : Institute of Medicine,Committee to Advise the Public Health Service on Clinical Practice Guidelines
Publisher : National Academies Press
Page : 169 pages
File Size : 55,7 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.