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| Chapter 4 Workbook |
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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.
1.2 Briefly define pharmacokinetic studies and toxicological
studies.
1.3 Briefly describe the four phases in clinical trials, including
purpose,
objectives, and process.
2.0 What is the most common research design used for clinical
trials?
Briefly describe the design.
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.
3.2 Selection of the investigators for clinical research depends on
______________.
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?
3.4 What is the principal investigator responsible for?
EXERCISE 2
4.0 Define and describe informed consent.
5.0 Describe the role of clinical monitoring.
6.0 What is the role of the institutional review committee (IRC)?
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