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
Author: Medicines And Healthcare Products Regulatory Agency
Publisher: Stationery Office/Tso
This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape. Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights. Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes: informed consent; investigator and sponsor responsibilities; site monitoring; institutional review boards and dependent ethics committees; clinical trial registration and reporting; quality assurance; and future implications for good clinical practices. Principles of Good Clinical Practice will be a definitive text for Clinical Development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries
Author: Michael J. McGraw,Shawn P. Shearn
Publisher: Pharmaceutical Press
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
A Guide for Good Clinical Practice (GCP) Inspections
Author: Vera Mihajlovic-Madzarevic
Publisher: John Wiley & Sons
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
Author: Delva Shamley,Brenda Wright
Publisher: Academic Press
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!
Author: Mark P. Mathieu
Publisher: Parexel International Corporation
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.
Standard Operating Procedures for Clinical Researchers
Author: Josef Kolman,Paul Meng,Graeme Scott
Publisher: John Wiley & Sons
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.
How to Meet International Quality Standard in Clinical Research
Author: Cemal Cingi,Nuray BAYAR MULUK
Author: DAVID. HUTCHINSON
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: Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Publisher: National Academies Press
Clinical Practice Guidelines for Midwifery & Women's Health, Fifth Edition is an accessible and easy-to-use quick reference guide for midwives and women’s healthcare providers. Completely updated and revised to reflect the changing clinical environment, it offers current evidence-based practice, updated approaches, and opportunities for midwifery leadership in every practice setting. Also included are integrative, alternative, and complementary therapies. The Fifth Edition examines the transition to the use of ICD-10 codes, women’s health policy and advocacy, risk assessment and decision-making in practice, and inspiring trust in midwifery care. New clinical practice guidelines include health promotion and primary care practice, such as promoting restorative sleep, optimizing oral health, promoting a healthy weight, and caring for the woman with a substance abuse disorder.
Author: Nell L. Tharpe,Cindy L. Farley,Robin G. Jordan
Publisher: Jones & Bartlett Learning
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: 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
Accompanying CD-ROM has the full text of the book in electronic format with linking, classification, and coding, with filtering, keyword searching, and the option to rearrange content.
A Guide to Clinical Practice
Author: Alba DiCenso,Gordon Guyatt,Donna Ciliska
Publisher: Elsevier Health Sciences
This book aims to demystify clinical trials. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language the book explains with illustrations of numerous trial examples, the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often feel uncertain and this material helps them review, appraise and publish trials and clinical evidence.
A Practical Guide to Design, Analysis, and Reporting
Author: Duolao Wang,Ameet Bakhai
Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global consequences. By the best-selling author of Bad Science.
How Drug Companies Mislead Doctors and Harm Patients
Author: Ben Goldacre
Category: Business & Economics
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.
Implementing Good Clinical Practice
Author: Gerhard Fortwengel
Publisher: Karger Medical and Scientific Publishers
redefining the standards of care for infants, children, and families with special needs ; overview & recommendations
Author: Interdisciplinary Council on Developmental and Learning Disorders
Long-Term Care Medicine: A Pocket Guide lessens the uncertainty involved in caring for patients in a long-term care facility. This practical pocket guide is divided into four sections: Introduction, Common Clinical Conditions, Psychosocial Aspects, and Special Issues in Long-Term Care. The chapters address all the varied components of the LTC system as well as how to take care of the patients and residents living within it. The contributors to this easy-to-read guide are passionate about LTC and many have worked within the American Medical Directors Association to create and disseminate a knowledge base for practitioners. Long-Term Care Medicine: A Pocket Guide is an invaluable resource for clinicians, practitioners, and educators who are seeking to optimize the care and living experience of residents in LTC by providing resident-centered care as well as resident choice, well-being, dignity, and an improved quality of life.
A Pocket Guide
Author: Pamela A. Fenstemacher,Peter A. Winn
Publisher: Springer Science & Business Media
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 guidelines--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 functioning--exploring issues such as patient information, liability, costs, computerization, and the adaptation of national guidelines to local needs.
From Development to Use
Author: Committee on Clinical Practice Guidelines,Institute of Medicine
Publisher: National Academies Press
The most recent guidelines and policy statements from the American Academy of Pediatrics keeps pediatricians and care providers current with important clinical and policy information.
A Compendium of Evidence-based Research for Pediatric Practices
Author: American Academy of Pediatrics