Synopsis
Clinical research management including the management of clinical trials is a complex activity involving several different individuals with varying educational and professional backgrounds. Research investigators, clinical research coordinators, research nurses, monitors, IRB staff, regulatory personnel, to name a few, all play an important role in clinical trial and clinical research management. . The Society of Clinical Research Associates (SOCRA) provides an important forum for the education, and training of clinical research professionals. A significant component of this training is the certification exam which results in the CCRP (Certified Clinical Research Professional) designation. This designation is particularly important to clinical research coordinators and research nurses who provide the main site-associated support for clinical trial and clinical research management. The certification serves as an important milestone in career development and can assist clinical research coordinators in careers in both academic and teaching hospitals, CROS, as well as within the pharmaceutical industry.The examination evaluates knowledge, understanding, and application of the conduct of clinical research and clinical trials involving humans. It tests the familiarity with “the International Conference on Harmonisation Guideline for Good Clinical Practice (E6) (ICH/GCP), ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A), the United States Code of Federal Regulations (CFR) and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki.”This workbook provides one tool for the preparation and study for the CCRP examination. The book addresses the key issues in in ICH-GCP , federal regulations outlined in statutes including Title 45 part 46 (Protection of Human Subjects) , Title 21 part 50 ( Protection of Human Subjects), Title 21 part 56 (Institutional review Boards) Title 21 part 54 (Financial Disclosures by Clinical Investigators) . Also addressed are key FDA statutes involved in the regulation of clinical trials Title 21 part 312 (Investigational New Drug Application), Tile 21 part 812 (Investigational Device Exemptions) and Title 21 part 11(Electronic Records and Electronic Signatures). The CCRP exam covers material based not only on these regulations but also on guidances issued by OHRP and the FDA The workbook is organized in distinct chapters each of which covers one aspect of the regulations or guidances. The multiple choice questions are deliberately designed to instruct on core materials rather than offering linguistically ingenious choices. The workbook is therefore designed not only to prepare for the CCRP examination but also to educate clinical research professionals, particularly clinical research coordinators and research nurses on matters which arise frequently in clinical research management and administration.
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