National University




General Course Information for CAF605: Good Clinical Practice (GCP)

Course: CAF605 - Good Clinical Practice (GCP)
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 is designed to present an introduction to the global regulations governing the conduct of clinical trials and for regulatory approval of a new biologic, medical device, or pharmaceutical product. The student will be introduced to EMA, FDA andamp; ICH regulations and standards, regulatory violations documented in warning letters, clinical roles and responsibilities, as well as the IRB/IEC process, and key study documents and principles of clinical study management.
Course Learning Outcomes:
  • Appraise the key elements of GCPs and the equivalent elements contained in the ICH guidelines for the conduct of human clinical trials.
  • Contrast the key clinical trial conduct responsibilities that apply to a study sponsor, an IRB, and a study investigator.
  • Examine the key steps chronologically for the set up and operation of a clinical trial.
  • Select the essential documents required to conduct a clinical trial.
  • Evaluate the key sections of a basic study protocol and informed consent form.
  • Design a clinical study report summarizing clinical trial results.
  • Assemble key FDA nomenclature pertaining to Good Clinical Practice Regulations.
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