Author:
Dubinsky, P. Michael, author.
ImprintHoboken, NJ : Wiley, 2022.
Descriptionxii, 516 pages, 22 unnumbered pages of plates : color illustrations ; 24 cm
Note:Part I. Good Clinical Practice History -- History / P. Michael Dubinsky -- Part II. Drug Development in the Regulatory Environment -- Regulatory Environment / P. Michael Dubinsky -- GCP in Context / P. Michael Dubinsky -- The Intersection of GCP and Regulation / P. Michael Dubinsky -- Regulatory Affairs / P. Michael Dubinsky -- Part III. Good Clinical Practice -- GCP Definition and Principles / Karen A. Henry -- Players Roles and Responsibilities Overview / Karen A. Henry -- IRB/IEC Roles and Responsibilities / P. Michael Dubinsky -- Investigator and Sponsor Roles and Responsibilities / Karen A. Henry -- The Research Volunteer / Karen A. Henry -- Regulatory Authority: Roles and Responsibilities / P. Michael Dubinsky -- Part IV. Individual Clinical Trial -- Individual Clinical Trial Overview / Karen A. Henry -- Risk Assessment and Quality Management / P. Michael Dubinsky -- Trial Management; Start-up, On-Study, and Close-Out / Karen A. Henry -- Trial Resourcing and Outsourcing / Karen A. Henry -- The Investigator's Brochure / Karen A. Henry -- The Investigational Product (Clinical Supplies) / P. Michael Dubinsky -- The Clinical Trial Protocol and Amendments / Karen A. Henry -- Informed Consent and Other Human Subject Protection / Karen A. Henry -- Data Collection and Data Management / Karen A. Henry -- Safety Monitoring and Reporting / Karen A. Henry -- Monitoring Overview / Karen A. Henry -- Investigator/Institution Selection / Karen A. Henry -- Investigator/Institution Initiation / Karen A. Henry -- Investigator/Institution Interim Monitoring / Karen A. Henry -- Investigator/Institution Close-out / Karen A. Henry -- Study Design and Data Analysis / Karen A. Henry -- The Clinical Study Report / Karen A. Henry -- Essential Documents / Karen A. Henry -- Part V. Quality in Clinical Trials -- Quality Systems in Clinical Research / P. Michael Dubinsky -- Quality Responsibilities / P. Michael Dubinsky -- Standard Operating Procedures / P. Michael Dubinsky -- Quality Assurance Components / P. Michael Dubinsky -- Regulatory Authority Inspections / P. Michael Dubinsky.
Bibliography Note:Includes bibliographical references and index.
Note:"Over the last 15-18 years good clinical practice (GCP) has emerged as the framework, from the standpoint of ethical and regulatory expectations, for the conduct of biomedical clinical studies in humans. GCP is mentioned in all existing clinical trial texts, manuscripts, papers, and presentations and it has become law in a number of global regions and countries. GCP provides a practical framework for clinical trial professionals to work within and guides them to abide by regulatory requirements. In turn, the regional and country regulatory authorities integrate GCP into their clinical trial regulations, adopt it to their existing regulations, or utilize it as guidance / best practice."-- Provided by publisher.
