Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and published by Wiley. This book was released on 2010-06-01 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and published by John Wiley & Sons. This book was released on 2010-09-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book A Comprehensive and Practical Guide to Clinical Trials written by Delva Shamley and published by Academic Press. This book was released on 2017-06-07 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book GCP Auditing written by German Society for Good Research Practice and published by Editio Cantor. This book was released on 2003 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Due to the "Good Clinical Practice" (GCP) requirements the high demands of quality assurance internationally became an integral part in the conduct of clinical trials. The conducting of audits enables pharmaceutical companies, CROs, authorities etc. to verify whether the required standards are complied with. The methods used for the planning, conducting and evaluation of auditing measures are presented in detail. Thus this textbook provides the necessary material for both the audits as such and for their evaluation. Different fields of work are presented--investigator, clinic, laboratory and CROs. The subjects dealt with include the trial protocol, information for study participants, computer system validation, validation in clinical studies employing electronic data capture systems, audit schedule and audit report. The authors (members of a board of experts of the Deutsche Gesellschaft fur Gute Forschungspraxis, DGGF; German Society for Good Research Practice) work in the pharmaceutical industry or at CROs and have had many years of experience in the quality assurance field.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Design and Analysis of Clinical Trials written by Shein-Chung Chow and published by John Wiley & Sons. This book was released on 2008-12-04 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancer clinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Guide for Clinical Trial Staff written by Gerhard Fortwengel and published by Karger Medical and Scientific Publishers. This book was released on 2004 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book A Step by step Guide to Clinical Trials written by Marilyn Mulay and published by Jones & Bartlett Learning. This book was released on 2001 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a practical approach to understanding the components of a clinical research trial as well as the tools to conduct a well-organized study. Designed for those interested in developing or enhancing skills to coordinate all aspects of clinical trials such as regulatory requirements, budgeting, contracts, patient recruitments and participation, and gathering and recording clear, invaluable data.
Download or read book Publishing and Presenting Clinical Research written by Warren S. Browner and published by Lippincott Williams & Wilkins. This book was released on 2012-03-19 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publishing and Presenting Clinical Research, Fourth Edition is an excellent primer for investigators who wish to learn how to organize, present, and publish results of their research. Written by an experienced clinical researcher and editor, it uses hundreds of examples, tables and figures to show how to produce successful abstracts, posters, oral presentations, and manuscripts for publication. This book also serves as a companion to the popular text, Designing Clinical Research. This edition contains the latest: • Guidance on getting work accepted in medical journals and at scientific meetings • Examples of the do’s and don’ts of data presentation • Explanations of confusing statistical terminology • Templates to get started and avoid writers’ block • Tips for creating simple graphics and tables • Help for those who are not fluent in English • Suggestions about getting the most from a poster session • Checklists for each section of a manuscript or presentation • Advice about authorship and responding to reviewers’ comments Plus with this edition, there is access to a companion website with fully searchable text so you can access the content anytime, anywhere.
Download or read book Preparing for FDA Pre Approval Inspections written by Martin D. Hynes and published by CRC Press. This book was released on 2016-04-19 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th
Download or read book Becoming A Successful Clinical Trial Investigator written by P. K. Julka and published by Dna Press. This book was released on 2009* with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Trials Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2009-06-17 with total page 1247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Download or read book Principles for Best Practice in Clinical Audit written by and published by Radcliffe Publishing. This book was released on 2002 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical audit is at the heart of clinical governance. Provides the mechanisms for reviewing the quality of everyday care provided to patients with common conditions like asthma or diabetes. Builds on a long history of doctors, nurses and other healthcare professionals reviewing case notes and seeking ways to serve their patients better. Addresses the quality issues systematically and explicitly, providing reliable information. Can confirm the quality of clinical services and highlight the need for improvement. Provides clear statements of principle about clinical audit in the NHS.
