Search results for: good-clinical-practice

Principles of Good Clinical Practice

Author : Michael J. McGraw
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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

Good Clinical Practice A Question Answer Reference Guide

Author : Mark P. Mathieu
File Size : 55.21 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!

Good Clinical Practice Guide

Author : Medicines And Healthcare Products Regulatory Agency
File Size : 38.7 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

Good Clinical Practice

Author : Josef Kolman
File Size : 37.24 MB
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An essential book for all those clinicians and reserachers undertaking clinical trials. It will ensure that all involved in clinical trials undertake their investigation according to standard operating procedures.

Quick Guide to Good Clinical Practice

Author : Cemal Cingi
File Size : 76.11 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.

Promoting Good Clinical Practice

Author : Maria-Racella de Guzman
File Size : 30.57 MB
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The American Physical Therapy Association, which has become one of the most recognized organizations representing the profession, continues to report the expansion of research in the field. As part of the Vision 2020 strategic plan, basic clinical research is mentioned to be an element essential to the physical therapy profession.12 The science behind physical therapy has existed for years with research starting in the early 1940s. This included the start of the clinical trials for the Salk vaccine to eradicate polio in the United States by the 1960s.13 According to the APTA, physical therapy is “a dynamic profession with an established theoretical and scientific base and widespread clinical application in the restoration, maintenance, and promotion of optimal physical functions”.14 The term “physical therapy” is also synonymous with the word “physiotherapy”. The practitioner of PT is known as a physiotherapist or a physical therapist. Physical therapists undergo proper higher education, licensure, and continuing education courses to maintain their role in the most current and up-to-date techniques and services.14 In addition, physical therapists assume a leadership role in patient rehabilitation, prevention, and health maintenance. Lastly, physical therapists help in the development of health care policy by ensuring that services of PT are available, accessible, and optimal.14 Minimal knowledge exists regarding how federal regulations apply to physical therapy research, but there is the justifiable assumption that all federal regulations should apply. Only a modest recognition is identified from the local IEC/IRB committees that overlook human subject clinical trials in physical therapy. The 2011 strategic plan of the Section of Research (SOR) in the APTA emphasizes the effort of increasing research education opportunities, but does not overlook the responsibility of the physical therapy researcher in practicing good clinical practices for the protection of human subjects in research trials.12 Twenty-first century medicine strives to evolve into an evidence-based practice, requiring real evidence that the determined way of treatment is the best option for the patient.15 The APTA has made recognition on its website that the PT profession should equally do the same. The key topic of implementing evidence-based practice in PT is emphasized in the Clinical Research Agenda. The goal of the APTA is to guide every practicing PT to understand that research is important to their clinical practice. Younger generation physical therapists should participate in research projects so that the future of PT practice is built upon factual evidence rather than experience.16 The main goal is that research should establish clinical practice, and that treatment should be decided upon evidence. Lastly, research evidence should be valid. Valid and qualitative evidence in research is important to physical therapy research. “Quality,” defined by the ISO 9000 addresses this as a set of standards in which an organization fulfills customer quality requirements and applicable regulatory requirements.17 Aiming to enhance customer satisfaction and achieving continual improvement are also acknowledged in the ISO. Quality evidence is important in clinical trials because the core components of research help ensure that patient protection follow the compliance of ICH GCP, and validates the integrity of data. The customers of clinical trials are those that benefit from the development of drugs, devices, and methods of preventative medicine, whether they are the research subjects, patients with a particular illness for which the study is being investigated for, physicians treating the patients, or for society.18

Good Clinical Practice

Author :
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Note for Guidance on Good Clinical Practice CPMP ICH 135 95

Author : Drug Information Association
File Size : 27.50 MB
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MRC Guidelines for Good Clinical Practice in Clinical Trials

Author :
File Size : 82.28 MB
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Good Clinical Practice in Children and Adolescents

Author : Muḥammad Riz̤ā Muḥammadī
File Size : 21.39 MB
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Good clinical practice (GCP) is a series of systematically developed ethical and quality standard of designing, registering, running, recording, and reporting of the clinical trials. Good clinical practice is very important regarding the trials usually performed on the vulnerable populations especially children and adolescents. The sensitivity of the issue is even higher in the children with psychiatric disorders. Usually, these children have little legal protection. Hence, the safety of interventions and the ethical considerations are among the most important issues in this field. The purpose of this chapter is to deal with above problems and globally applicable standards for the conduct of clinical trials on the under legal age subjects especially those with psychiatric disorders. Selection of trial subjects, ethical principles, regulatory requirements, protection of trial subjects, monitoring (compliance with the protocol), responsibilities of the investigator, and other requirements to perform a clinically and ethically sound clinical trial in children and adolescents will be discussed in this chapter.

Good Clinical Practice in Assisted Reproduction

Author : Paul Serhal
File Size : 75.94 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.

Clinical Trials Audit Preparation

Author : Vera Mihajlovic-Madzarevic
File Size : 25.20 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

ICH GCP Guidelines

Author :
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Guide to Good Clinical Practice

Author : Mary Bernadette Ott
File Size : 62.52 MB
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Medical Research Council Guidelines for Good Clinical Practice in Clinical Trials

Author : Medical Research Council (Great Britain).
File Size : 40.11 MB
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Good Clinical Laboratory and Manufacturing Practices

Author : Phillip A. Carson
File Size : 29.59 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.

Good Clinical Practice eRegs Guides For Your Reference Book 2

Author : eRegs & Guides
File Size : 81.53 MB
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Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: E6 Good Clinical Practice Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application CFR 21-- General Part 11, Electronic Records; Electronic Signatures 21 CFR PART 50 Protection Of Human Subjects 21 CFR Part 54 Financial Disclosure By Clinical Investigators 21 CFR PART 56 Institutional Review Boards Title 21 PART 312 Investigational New Drug Application ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting ICH E8 General Considerations For Clinical Trials

Good Clinical Practice eRegs Guides For Your Reference Book 6

Author : eRegs & Guides
File Size : 67.19 MB
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Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: ICH - Safety Guidelines S1A – S9 S1A Guideline on the Need for Carcinogenicity Studies S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) S5(R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S7A Safety Pharmacology Studies For Human Pharmaceuticals S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals S8 Immunotoxicity Studies for Human Pharmaceuticals S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

Good Clinical Practice eRegs Guides For Your Reference Book 7

Author : eRegs & Guides
File Size : 32.26 MB
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Financial Conflict Of Interest Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) Responsible Prospective Contractors (45 C.F.R. Part 94)

Good Clinical Practice eRegs Guides For Your Reference Book 4

Author : eRegs & Guides
File Size : 85.75 MB
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Good Clinical Practice For Your Reference - Book 4 ICH - Clinical Safety E1 - E2F ICH-E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions ICH-E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting ICH-E2B(R2) Clinical Safety Data Management : Data Elements for Transmission of Individual Case Safety Reports ICH-E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs ICH-E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting ICH-E2E Pharmacovigilance Planning ICH-E2F Development Safety Update Report Samples of DSURS European Directive 2001/20/EC European Directive 2005/28/EC