Syllabus for CTM-540

ETHICAL ISSUES AND REGULATORY PRINCIPLES IN CLINICAL RESEARCH


COURSE DESCRIPTION

The purpose of this course is to gain a better understanding of the ethical issues and regulatory principles in clinical research. Each module has been designed to be a step-wise approach to understanding clinical research and how today’s regulations impact tomorrow’s drugs. Modules 1-3 take students through basics regulations. Module 1 discusses the basic of the Food and Drug Administration (FDA) by exploring the FDA’s structure, history, and goals; Module 2 is an introduction to basic guidelines used when conducting clinical trials; and Module 3 talks about the primary applications that must be submitted to the FDA for drug approval. All 10 modules discuss ethics in clinical research; Modules 4-5 dig deeper into the realm of ethics by exploring early ethical guidelines, such as the Nuremberg Code and the Declaration of Helsinki; Module 5 then applies these guidelines to current practice. Modules 6-8 take the time to explore essential regulatory documents, regulatory inspections, and adverse event and safety monitoring, all essential aspects of running clinical trials. Finally, Modules 9-10 explore regulatory guidelines outside of the United States by discussing the basic regulatory guidelines in 21 other countries around the world. Each module has exercises designed to further enhance the student’s drug development knowledge through reading, discussion boards, and assignments.

COURSE MATERIALS

You will need the following materials to complete your coursework. Some course materials may be free, open source, or available from other providers. You can access free or open-source materials by clicking the links provided below or in the module details documents. To purchase course materials, please visit the University's textbook supplier.

Required Textbook

        

For latest version, check online at Electronic code of Federal Regulations - Title 21 Food and Drugs (Browse Volumes 4 and 5)

COURSE STRUCTURE

Ethical Issues and Regulatory Principles in Clinical Research is a three-credit online graduate course, consisting of ten modules. Modules include topics, learning objectives, study materials, and activities. Module titles are listed below.

ASSESSMENT METHODS

For your formal work in the course, you are required to participate in online discussion forums and complete written assignments. See below for more details.

Consult the Course Calendar for assignment due dates.

Promoting Originality

One or more of your course activities may utilize a tool designed to promote original work and evaluate your submissions for plagiarism. More information about this tool is available in this document.

Discussion Forums

This course requires you to participate in three graded discussion forums. There is also an ungraded but required introductions forum in Module 1.

Online discussions provide an opportunity for you to interact with your classmates. During this aspect of the course, you respond to prompts that assist you in developing your ideas, you share those ideas with your classmates, and you comment on their posts. Discussion board interactions promote development of a community of learners, critical thinking, and exploratory learning.

Please participate in online discussions as you would in constructive face-to-face discussions. You are expected to post well-reasoned and thoughtful reflections for each item, making reference, as appropriate, to your readings. You are also expected to reply to your classmates' posts in a respectful, professional, and courteous manner. You may, of course, post questions asking for clarification or further elucidation on a topic.

For posting guidelines and help with discussion forums, please see the Student Handbook located within the General Information page of the course Web site.

Written Assignments

You are required to complete ten written assignments. The written assignments are on a variety of topics associated with the course modules.

For help regarding preparing and submitting assignments, see the Student Handbook located within the General Information page of the course Web site.

GRADING AND EVALUATION

Your grade in the course will be determined as follows:

All activities will receive a numerical grade of 0–100. You will receive a score of 0 for any work not submitted. Your final grade in the course will be a letter grade. Letter grade equivalents for numerical grades are as follows:

A

=

93–100

B

=

83–87

A–

=

90–92

C

=

73–82

B+

=

88–89

F

=

Below 73

To receive credit for the course, you must earn a letter grade of C or higher on the weighted average of all assigned course work (e.g., assignments, discussion postings, projects, etc.). Graduate students must maintain a B average overall to remain in good academic standing.

STRATEGIES FOR SUCCESS

First Steps to Success

To succeed in this course, take the following first steps:

Study Tips

Consider the following study tips for success:

ACADEMIC POLICIES

To ensure success in all your academic endeavors and coursework at Thomas Edison State University, familiarize yourself with all administrative and academic policies including those related to academic integrity, course late submissions, course extensions, and grading policies.

For more, see:

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