Author: Joyce A. Cramer
Edition:
Publisher: Raven Pr
Binding: Hardcover
ISBN: 0881677353
Patient Compliance in Medical Practice and Clinical Trials
Patient noncompliance with medical regimens is a major factor in therapeutic failure and is particularly detrimental to clinical trials. Medical books Patient Compliance in Medical Practice and Clinical Trials. This text aims to address the entire scope of compliance issues, and describes electronic monitoring devices that record actual dose times. Traditional methods of assessing compliance, such as patient history, drug levels, and counting pills or prescription refills, are also discussed. The review of everyday clinical problems facing practitioners everywhere is complemented by discussions on the impact of noncompliance in research and the drug regulatory process. Health care providers in all fields as well as clinical trial researchers should find useful ideas throughout the book Medical books Clinical Trials Audit Preparation Ebook. 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:
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Good Clinical Practices and therapeutic product development in clinical research
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The roles of the sponsor of a clinical investigation, the irb, or independent ethics committee
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The roles and responsibilities of the clinical trial investigator
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The inspection preparation
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The Audit Report and the Form 483
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Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Download link for Data Monitoring in Clinical Trials ...
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 institu
A must-have guide for any professional in the drug manufacturing industryThe 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 institu
"In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. The book focuses on issues occurring at various stages of clinical research and development, includ
"In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. The book focuses on issues occurring at various stages of clinical research and development, includ
Medical Book Patient Compliance in Medical Practice and Clinical Trials
This text aims to address the entire scope of compliance issues, and describes electronic monitoring devices that record actual dose times. Traditional methods of assessing compliance, such as patient history, drug levels, and counting pills or prescription refills, are also discussed. The review of everyday clinical problems facing practitioners everywhere is complemented by discussions on the impact of noncompliance in research and the drug regulatory process. Health care providers in all fields as well as clinical trial researchers should find useful ideas throughout the book.
