National University




General Course Information for CAF650: Clinical Operations Part 1

Course: CAF650 - Clinical Operations Part 1
Textbook: For the correct edition of the textbook assigned to a specific class, go to: http://www.nutextdirect.com

Course Prerequisite(s):

Recommended: Prior completion of

Course Description: This course provides the student with an in-depth foundation for all operational aspects in the process of clinical research. The focus will be on developing, executing, and completing a single clinical trial. There will be detailed exploration of all aspects of the responsibilities of investigators and sponsors and the key operational aspects involved in setting up, running, monitoring, and completing a clinical trial. This Part 1 covers all requirements and activities through clinical trial initiation.
Course Learning Outcomes:
  • Compare the key components in Good Clinical Practices, including responsibilities of investigators and sponsors.
  • Support the key components of preparation for the conduct of clinical trials.
  • Evaluate the activities involved in all operational aspects of the conduct of clinical trials.
  • Appraise the requirements for, and activities involved in, the close-out of a completed (or terminated) clinical trial.
  • Argue the regulatory foundations for all components of the clinical operation process.
  • Contrast this clinical operation knowledge to real-life biomedical product development environments.
Specified Program Learning Outcomes:
  • Master of Science in Clinical Affairs
    • Apply knowledge of human rights obligations, the clinical life cycle, and adverse events to the design of a clinical trial.
    • Conduct a clinical trial regulatory audit/inspection.
    • Design a methodology for a clinical trial with supportive data management and data analysis.
    • Design and evaluate clinical trials.
    • Employ the global regulations, standards, and GCPs involved in designing, implementing and managing clinical trials for biologics, medical devices, and drugs.
    • Select and utilize standard biomedical clinical affairs operating policies, procedures, forms, templates, reports, and electronic records.
    • Write compliance documents for clinical trials.

Students with Disabilities:
Students seeking special accommodations due to a disability must submit an application with supporting documentation, as explained under this subject heading in the General Catalog. Instructors are required to provide such accommodations if they receive written notification from the University.

Writing Across the Curriculum:
Students are expected to demonstrate writing skills in describing, analyzing and evaluating ideas and experiences. Written reports and research papers must follow specific standards regarding citations of an author's work within the text and references at the end of the paper. Students are encouraged to use the services of the University's Writing Center when preparing materials.

The following website provides information on APA, MLA, and other writing and citation styles that may be required for term papers and the like: http://nu.libguides.com/citations

National University Library:
National University Library supports academic rigor and student academic success by providing access to scholarly books and journals both electronically and in hard copy. Print materials may be accessed at the Library in San Diego or through document delivery for online and regional students. Librarians are available to provide training, reference assistance, and mentoring at the San Diego Library and virtually for online or regional students. Please take advantage of Library resources:

URL: http://www.nu.edu/library.

Contact the Library:

  • RefDesk@nu.edu
  • (858) 541-7900 (direct line)
  • 1-866-NU ACCESS x7900 (toll free)

Use the Library Training Tools (on the Library Homepage) for additional help

  • Recorded class presentations
  • Tutorials & Guides (APA/MLA, Peer-Review, and more)

Plagiarism:
Plagiarism is the presentation of someone else's ideas or work as one's own. Students must give credit for any information that is not either the result of original research or common knowledge. If a student borrows ideas or information from another author, he/she must acknowledge the author in the body of the text and on the reference page. Students found plagiarizing are subject to the penalties outlined in the Policies and Procedures section of the University Catalog, which may include a failing grade for the work in question or for the entire course. The following is one of many websites that provide helpful information concerning plagiarism for both students and faculty: http://www.indiana.edu/~wts/pamphlets/plagiarism.shtml

Ethics:
Ethical behavior in the classroom is required of every student. The course will identify ethical policies and practices relevant to course topics.

Technology:
Students are expected to be competent in using current technology appropriate for this discipline. Such technology may include word processing, spreadsheet, and presentation software. Use of the internet and e-mail may also be required.

Diversity:
Learning to work with and value diversity is essential in every class. Students are expected to exhibit an appreciation for multinational and gender diversity in the classroom.

Civility:
As a diverse community of learners, students must strive to work together in a setting of civility, tolerance, and respect for each other and for the instructor. Rules of classroom behavior (which apply to online as well as onsite courses) include but are not limited to the following:

  • Conflicting opinions among members of a class are to be respected and responded to in a professional manner.
  • Side conversations or other distracting behaviors are not to be engaged in during lectures, class discussions or presentations
  • There are to be no offensive comments, language, or gestures