Syllabus for CTM-530

INTRODUCTION TO CLINICAL TRIALS DATA MANAGEMENT


COURSE DESCRIPTION

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.

COURSE OBJECTIVES

After completing this course, you should be able to:

  1. Explain the regulations governing the data management process.
  2. Describe a typical data management process.
  3. Identify the roles and responsibilities of different personnel involved in the research process.
  4. Define the function of the data manager.
  5. Discuss the importance and procedures of data collection.
  6. Follow the procedures to handle an Adverse Drug Events (ADE) and Serious Adverse Drug Events (SAEs)
  7. Review database structure and design.
  8. Identify important parameters for data review, coding, queries, and validation.
  9. Develop strategies to manage practical issues that may arise.

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

ISBN-13: 978-0470046081

Additional readings – journal articles, websites etc.. may be provided for specific assignments.

Useful texts/readings/websites

In addition to resources utilized for other classes in this curriculum, suggested texts and websites include:

COURSE STRUCTURE

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.

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 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.

GRADING AND EVALUATION

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.

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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