CCRC EXAM STUDY GUIDE: ACRP CERTIFICATION

Author by : Pramod Lad
Languange Used : en
Release Date : 2018-10-09
Publisher by :

ISBN :

Description : 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....

Author by : Deborrah Norris
Languange Used : en
Release Date : 2004
Publisher by : Plexus Publishing (UK)

ISBN :

Description : In this revised third edition of the essential reference for clinical research coordinators (CRCs), Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book's five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, a glossary, and more....

Author by : Karen E. Woodin
Languange Used : en
Release Date : 2004
Publisher by : CenterWatch

ISBN :

Description : This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice....

Author by : Pramod Lad
Languange Used : en
Release Date : 2019-03-24
Publisher by :

ISBN :

Description : This is a companion volume to the CCRP EXAM WORKBOOK. The sequence of chapters is the same in both books to facilitate parallel review. The study guide provides the didactic material while the exam workbook provides test questions pertaining to it. For maximum effectiveness in exam preparation the two volumes should be studied together. 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 study guide 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 study guide is organized in distinct chapters each of which covers one aspect of the regulations or guidances. The chapters are deliberately designed to instruct on core materials.The study guide 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....

Author by : Chris Sauber
Languange Used : en
Release Date : 2019-04-21
Publisher by : Independently Published

ISBN :

Description : Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps...

Author by : Natasha Martien
Languange Used : en
Release Date : 2018-08-01
Publisher by : Academic Press

ISBN :

Description : A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly...

Author by : Crc Exam Secrets Test Prep
Languange Used : en
Release Date : 2018-04-12
Publisher by :

ISBN :

Description : ***Includes Practice Test Questions*** CRC Exam Secrets helps you ace the Certified Rehabilitation Counselor Exam, without weeks and months of endless studying. Our comprehensive CRC Exam Secrets study guide is written by our exam experts, who painstakingly researched every topic and concept that you need to know to ace your test. Our original research reveals specific weaknesses that you can exploit to increase your exam score more than you've ever imagined. CRC Exam Secrets includes: The 5 Secret Keys to CRC Exam Success: Time is Your Greatest Enemy, Guessing is Not Guesswork, Practice Smarter, Not Harder, Prepare, Don't Procrastinate, Test Yourself; A comprehensive General Strategy review including: Make Predictions, Answer the Question, Benchmark, Valid Information, Avoid Fact Traps, Milk the Question, The Trap of Familiarity, Eliminate Answers, Tough Questions, Brainstorm, Read Carefully, Face Value, Prefixes, Hedge Phrases, Switchback Words, New Information, Time Management, Contextual Clues, Don't Panic, Pace Yourself, Answer Selection, Check Your Work, Beware of Directly Quoted Answers, Slang, Extreme Statements, Answer Choice Families; A comprehensive content review including: Five Principles of Ethical Behavior, Cultural Diversity and Client Rights, Piaget's Cognitive Development Stages, Kohlberg's Phases of Moral Development, Maslow's Hierarchy of Needs, Ivan Pavlov's Experiments, Defense Mechanisms, Sigmund Freud's Psychoanalysis, Dream Analysis, Nature or Nurture, Gestalt Therapy, Fritz Perls' Therapeutic Foundation, Skinner's Operant Conditioning, Positive and Negative Reinforcement, Graphic Symbolism of Carl Jung, Myers-Briggs Type Indicator, Behavior Modification, Alfred Adler's Concept of Paradox, Characteristics of a Good Counselor, Existential Counseling, Reality Therapy, ABC Theory of Personality, Group Norms, Therapy Group Types, Leadership Styles, George Gaza's Types of Groups, and much more......