Gastroenterology Chapter 4 Research and Clinical Trials

Chapter 4 Workbook
LEARNER OBJECTIVES At the completion of this chapter, the learner will be able to: Section 1: Introduction 1.0 Describe clinical research regulations, including the roles and responsibilities of investigators, sponsors and institutions. Section 2-5: Regulations, Supervision, Development, Methodology, Planning of Trials. 2.0 Discuss the research process. 3.1 Preclinical trials. 3.2 Clinical trials, including: 3.2.1-3.2.4 four phases of clinical drug development 5.1 Protocol design and implementation. 5.2 Selection of investigators and centers. Section 6: Informed Consent Form and Ethical Issues 6.0 Define informed consent. Section 7: Clinical Monitoring 7.0 Discuss the role of clinical monitoring in clinical research. Section 8: Institutional Review Committee (IRC) 8.0 Define IRC (institutional review committee). LEARNER WORKBOOK EXERCISE 1 1.0 The research process includes both preclinical and clinical trials. 1.1 Briefly describe preclinical studies, including purpose, location for the studies, and role of pharmaceutical experts. Answer (section 3.1, p81, paragraph 2) 1.2 Briefly define pharmacokinetic studies and toxicological studies. Answer (section 3.1, p81, paragraph 2) 1.3 Briefly describe the four phases in clinical trials, including purpose, objectives, and process. Answer (section 3.2.1, 3.2.2, 3.2.3, 3.2.4, p82-83) 2.0 What is the most common research design used for clinical trials? Briefly describe the design. Answer (section 4, p83) 3.0 When planning clinical trials there are different components to include. These are protocol design, implementation, and selection of investigators and centers. 3.1 What should the study protocol include? List at least eight components and briefly describe each. Answer (section 5.1, p84) 3.2 Selection of the investigators for clinical research depends on ______________. Answer (section 5.2, p85) 3.3 What type of experts are used for Phase I and II studies? What type of experts are used for Phase III and IV studies? Answer (section 5.2, p85) 3.4 What is the principal investigator responsible for? Answer (section 5.2, p85) EXERCISE 2 4.0 Define and describe informed consent. Answer (section 6, p85) 5.0 Describe the role of clinical monitoring. Answer (section 7, p86) 6.0 What is the role of the institutional review committee (IRC)? Answer (section 8, p86)