National University




General Course Information for MRA 610B: Regulatory Affairs Internship

Course: MRA 610B - Regulatory Affairs Internship
Textbook: For the correct edition of the textbook assigned to a specific class, go to: http://www.nutextdirect.com

Course Description: This course is designed to give the student a "hands on" real world experience working in a clinical trial environment. The student will acquire fundamental knowledge in evidence based clinical data, statistical analysis and documentation of clinical results. The student will be required to write a critical evaluation of the clinical trial a complete analysis of methodology, clinical forms, FDA regulations and data management. Grading is by S or U only. Course is eligible for an "IP" grade.
Course Learning Outcomes:
  • Understand the implementation of protocol in a clinical trial.
  • Evaluate evidence based clinical data.
  • Develop a data management system with clinical trial outcomes.
  • Understand all documentation used in the clinical trial for FDA approval.
  • Design clinical report forms, standard operating procedures, compliance documentation IRB submittals and all other documents necessary for FDA approval.
  • Understand the FDA regulations as related to the clinical trial.
  • Understand audits and adverse events.
  • Be familiar with content and preparation for FDA meetings.

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