Syllabus for CTM-530
INTRODUCTION TO CLINICAL TRIALS DATA MANAGEMENT
This course provides an overview of the clinical data management process in pharmaceutical research settings. Introduction to Clinical Trials Data Management is one of four courses in the Clinical Trials Management curriculum.
After completing this course, you should be able to:
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.
ISBN-13: 978-0470046081
Additional readings – journal articles, websites etc.. may be provided for specific assignments.
In addition to resources utilized for other classes in this curriculum, suggested texts and websites include:
Introduction to Clinical Trials Data Management is a three-credit online graduate course, consisting of ten modules. Modules include an overview, learning objectives, study materials, and assignments. Module titles are listed below.
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.
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.
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.
You are required to complete eleven 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.
Your grade in the course will be determined by modules 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.
To succeed in this course, take the following first steps:
Consider the following study tips for success:
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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