Advanced-level courses covering specific topics in clinical laboratory sciences. Not more than six hours of special topics may be used on a degree program.
Credit 1 hr May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
Advanced-level courses covering specific topics in clinical laboratory sciences. Not more than six hours of special topics may be used on a degree program.
Credit 2 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
Permission of instructor is required for enrollment
Advanced-level courses covering specific topics in clinical laboratory sciences. Not more than six hours of special topics may be used on a degree program.
Credit 3 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
Permission of instructor is required for enrollment
Advanced-level courses covering specific topics in clinical laboratory sciences. Not more than six hours of special topics may be used on a degree program.
Credit 1 hr May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
Permission of instructor is required for enrollment
Advanced-level courses covering specific topics in clinical laboratory sciences. Not more than six hours of special topics may be used on a degree program.
Credit 2 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
Permission of instructor is required for enrollment
Advanced-level courses covering specific topics in clinical laboratory sciences. Not more than six hours of special topics may be used on a degree program.
Credit 3 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
Permission of instructor is required for enrollment
Lecture and discussion course of epidemiological measurements, applications, study design, disease risk assessment and interpretation. Epidemiology is the basic science of disease prevention and plays a major role in the development and evaluation of public policy. Risk factors for disease mechanisms involved in pathogenesis will be discussed.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Summer (odd yrs., in-person)
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
Equivalent Course(s) - Course History - Course Rotation added 9/2014, Prefix Change 2/2012, effective Fall 2012; Removal of Prerequisites 10/2011
Introduction to the pharmaceutical industry and the process of drug development. Drug development phases 1-4 are discussed. Regulatory requirements of the Food and Drug Administration are reviewed along with the content of the investigational new drug application (IND), the new drug application (NDA) and the marketing authorization application (international). The roles of investigator, coordinator, sponsor and monitor are discussed. Exposure to the skills necessary to function as a successful study monitor is given.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Fall (in-person)
Prerequisites - Corequisites -CLRA 520 Restriction by Major - Restriction by Degree Type - Graduate standing
Equivalent Course(s) - Course History - Course Rotation added 9/2014
Provides an overview of the development, content and process of the clinical research study. Topics include protocols, case report forms, investigator brochures, informed consent, institutional review boards and Statement of Investigator Form 1572.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Fall (in-person)
Prerequisites - Corequisites -CLRA 510 Restriction by Major - Restriction by Degree Type - Graduate standing
Equivalent Course(s) - Course History - Course Rotation added 9/2014, Course Revision 7/2014, Updated 2/2013, effective Summer 2013; May 2011
Course builds on the content of CLRA 520 and expands upon the processes involved in study management. Topics include source document verification, visit types, drug accountability, adverse events, laboratory and supplies.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Winter (in-person)
Prerequisites -CLRA 520 Restriction by Major - Restriction by Degree Type - Graduate standing
Additional Information - Students who can not satisfy enrollment restrictions may request department permission to enroll; enrollment is not guaranteed.
CLRA 540 Advanced Topics in Clinical Study Management
Capstone experience utilizes the background material presented in CLRA 510/CLRA 530 to integrate all of the components of a clinical research program and how they relate to the completed submission of a document to the U.S. Food and Drug Administration.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Winter (in-person)
Prerequisites -CLRA 530 Restriction by Major - Restriction by Degree Type - Graduate standing
Additional Information - Students who can not satisfy enrollment restrictions may request department permission to enroll; enrollment is not guaranteed.
CLRA 550 Preceptorship in Clinical Trial Management
The preceptorship is an individualized hands-on experience which gives the student on-the-job experience in both a clinical setting where patients are enrolled in clinical trials and a clinical research organization or pharmaceutical corporation where protocols are developed, implemented and monitored. Students interact with clinical research associates, clinical research coordinators and clinical scientists in a workplace setting to develop and polish clinical research coordinating and monitoring skills.
Credit 3 hrs May not be repeated for additional credit Grade Mode Credit/No-Credit Course Rotation Fall, Winter, and Summer (In-person)
Prerequisites -CLRA 540 Restriction by Major - Restriction by Degree Type - Graduate standing
Additional Information - Students who can not satisfy enrollment restrictions may request department permission to enroll; enrollment is not guaranteed.
Equivalent Course(s) - Course History - Change to title 10/2016, effective Fall 2017; Course Rotation added 9/2014
The preceptorship in Regulatory Affairs is an individualized hands-on experience which gives the study on-the-job experience in either in a clinical setting which gives the student on the job experience either in a clinical setting where patients are enrolled in regulated clinical trials or in a corporate environment where clinical protocols are developed, implemented and monitored. In both instances, students will interact with regulatory affairs professionals, institutional review board members and clinical scientists in a workplace setting.
Credit 3 hrs May not be repeated for additional credit Grade Mode Credit/No-Credit Course Rotation No planned offerings
CLRA 561 Legal and Management Issues in Clinical Research
This course provides an overview of key legal and management issues impacting clinical research administrators and others involved in drug development processes. Topics include the fundamentals of negligence, HIPAA and False Claims Act regulatory compliance, contracts, administrative agencies, patents, professional liability, risk management, and personnel leadership in clinical research environments.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Fall (in-person)
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
Additional Information - It is recommended that students take CLRA 510 prior to enrollment. They may register, however, if they have some familiarity with clinical research.
Equivalent Course(s) - Course History - Change to prerequisite 4/2019, effective Fall 2019; Note added 4/2019; Change to title, description, and credit hours 3/2018, effective Fall 2018; Change to title and description 12/2015, effective Fall 2016
CLRA 562 GCP Audits: Compliance, Fraud and Misconduct
Students will learn about Good Clinical Practice Audits and Regulatory Inspections and their role in assuring compliance as they apply to the development of drugs, biologics, and devices.
Credit 2 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Summer (in-person)
Prerequisites -CLRA 510 Restriction by Major - Restriction by Degree Type - Graduate standing
Equivalent Course(s) - Course History - New Course 1/2017, effective Fall 2017
CLRA 571 Grant and Contract Management for Research Project Administrators
This course will prepare future clinical research administrators and others involved in research administration, in the fundamentals of pre- and post-award management of research projects. Emphasis is given to understanding the terms and conditions of contracts and grant award documents, and to management issues involved in forming and managing sub-contractual relationships.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation No planned offerings
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate Standing
Equivalent Course(s) - Course History - Course Rotation added 9/2014
This graduate level course will focus on the ethical issues which are of concern during the conduct of clinical research. Topics will cover study planning, conduct and information dissemination.
CLRA 581 Introduction to Regulatory Affairs in Drug Development
This course provides a working knowledge of regulatory affairs with a primary focus on the pharmaceutical industry. Emphasis is on US research and development with drug discovery, clinical development, and regulatory strategy.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Winter (in-person)
Prerequisites -CLRA 510 Restriction by Major - Restriction by Degree Type - Graduate standing
Department Permission isrequired
Additional Information - Students who can not satisfy enrollment restrictions may request department permission to enroll; enrollment is not guaranteed.
Equivalent Course(s) - Course History - Change to title, description, and prerequisites 5/2022, effective Fall 2022; Course Rotation added 9/2014, 7/22/2011
CLRA 582 Regulatory Affairs in Drug Development II
This course is part of a 3-course sequence that provides a working knowledge of pharmaceutical regulatory affairs. Emphasis is on US development, although topics will include non-US development and the development of biologics, OTC and devices. This course focuses on marketing application (NDAs), labeling, marketing approval and product launch.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation No planned offerings
Prerequisites -CLRA 581 Restriction by Major - Restriction by Degree Type - Masters, Graduate Certificate, Degree Admit - Condition 4, UG Degree Pending
CLRA 583 Regulatory Affairs in Drug Development III
This course is part of a 3-course sequence that provides a working knowledge of pharmaceutical regulatory affairs. Emphasis is on a US development, although topics will include non-US development and the development of biologics, OTC and devices. This course addresses post-approval issues including advertising and promotion, drug safety and pricing.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation No planned offerings
Prerequisites -CLRA 581 and CLRA 582 Restriction by Major - Restriction by Degree Type - Masters, Graduate Certificate, Degree Admit - Condition 4, UG Degree Pending
Equivalent Course(s) - Course History - Course Rotation added 9/2014, 7/2011; May 2011
This course provides a working knowledge of regulatory affairs focusing on the medical device industry. Emphasis is on US development and approval, with topics that include 510(k), PMA, and technology.
Credit 2 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation Fall (in-person)
Prerequisites -CLRA 510 Restriction by Major - Restriction by Degree Type - Graduate standing
Equivalent Course(s) - Course History - Change to description and prerequisites 5/2022, effective Fall 2022; New Course 1/2017, effective Fall 2017
CLRA 585 Regulatory Writing and Electronic Submissions
Regulatory Affairs (RA) Specialists either in industry or academia are often required to write or review and edit various documents for submission to regulatory agencies and submit these documents electronically to regulatory agencies. This course will provide the basic knowledge required to perform these tasks. The course will include a practicum element with student license to specialized software.
Credit 2 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation No planned offerings
Prerequisites -CLRA 510 and CLRA 581 Restriction by Major - Restriction by Degree Type - Graduate standing
Equivalent Course(s) - Course History - New Course 1/2017, effective Fall 2017
Advanced-level courses covering specific topics in associated health professions. Not more than six hours of special topics may be used on a degree program.
Credit 1 hr May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation as needed (see Dept.)
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
Advanced-level courses covering specific topics in associated health professions. Not more than six hours of special topics may be used on a degree program.
Credit 2 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation No planned offerings
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
Advanced-level courses covering specific topics in associated health professions. Not more than six hours of special topics may be used on a degree program.
Credit 3 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation No planned offerings
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
Under the guidance and supervision of a faculty member of the clinical research administration program, the student will propose and finalize a research proposal for a thesis or special project.
Credit 1 hr Grade Mode Credit/No-Credit Course Rotation Fall (in-person)
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
Equivalent Course(s) - Course History - Course Rotation added 9/2014, Grading Option Change 4/2012, effective Fall 2012; New Course 1/2012
Intensive research into a problem under the guidance and supervision of a graduate faculty member of the clinical research administration program, and the preparation of a thesis consistent, in substance and form with the standards of the discipline.
Credit 1 hr May be repeated for additional credit Grade Mode Credit/No-Credit Course Rotation No planned offerings
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
Intensive research into a problem under the guidance and supervision of a graduate faculty member of the clinical research administration program, and the preparation of a thesis consistent, in substance and form with the standards of the discipline.
Credit 2 hrs May be repeated for additional credit Grade Mode Credit/No-Credit Course Rotation No planned offerings
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
Intensive research into a problem under the guidance and supervision of a graduate faculty member of the clinical research administration program, and the preparation of a thesis consistent, in substance and form with the standards of the discipline.
Credit 3 hrs May be repeated for additional credit Grade Mode Credit/No-Credit Course Rotation Winter (In-person)
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
CLRA 695 Research Project in Clinical Research Administration
The student will conduct an individualized research project under the direction of a CLRA faculty member. The student will write a formal research paper based on their research project, approved by the CLRA faculty member, to fulfill their capstone requirement.
Credit 3 hrs May not be repeated for additional credit Grade Mode Credit/No-Credit Course Rotation Winter (In-person)
Prerequisites - Restriction by Major - Restriction by Degree Type - Graduate standing
Department Permission isrequired
Permission from the instructor is required for enrollment.
Equivalent Course(s) - Course History - Change to title and description 5/2022, effective Fall 2022; Course Rotation added 9/2014, Course Description and Prerequisite Change 1/2012, effective Winter 2012
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 3 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 2 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 3 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
CASI 650 Current Challenges in Bioinformatics Seminar
This course provides an opportunity for students to work in teams on real-life problems of bioinformatics. Students will apply their team-building skills to solve problems provided by biotechnology and pharmaceutical companies. This course is specifically designed for students enrolled in the professional Master’s in Bioinformatics program.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation
Prerequisites - Restriction by Major - Restriction by Degree Type -
This course provides an introduction to applied bioinformatics in a professional, for-profit environment. Students have an opportunity to apply their technical, communication and teambuilding skills in biotechnology and pharmaceutical companies of all sizes. This course is specifically designed for students enrolled in the professional Master’s in Bioinformatics program.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation as needed (See Dept.)
Prerequisites - Restriction by Major - Restriction by Degree Type -
IHHS 552 Management of Health Care Delivery: Disasters & Bioterrorism
This foundational course is an examination of issues in natural and man-made disasters and bio terror events that impact the delivery of health care at local, state and national levels and the strategies necessary for preparedness, mitigation, response and evaluation in community environments. The course is designed to meet the knowledge needs and care preformed by pre-professional and professional health care providers; the lay public is also invited to join the course.
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 1 hr May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 2 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course designed to investigate specific topics of concern in the specialization areas of study. Not more than six hours of special topics may be used on a degree program.
Credit 3 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 1 hr May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 2 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 3 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. Subject matter will change from semester to semester. Students may elect this course more than once, provided different topics are covered.
Credit 1 hr May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. Subject matter will change from semester to semester. Students may elect this course more than once, provided different topics are covered.
Credit 2 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. Subject matter will change from semester to semester. Students may elect this course more than once, provided different topics are covered.
Credit 3 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. Subject matter will change from semester to semester. Students may elect this course more than once, provided different topics are covered.
Credit 1 hr May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. Subject matter will change from semester to semester. Students may elect this course more than once, provided different topics are covered.
Credit 2 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 1 hr May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation variable
Prerequisites - Restriction by Major - Restriction by Degree Type -
An experimental course for subject matter not provided in other departmental offerings. The content will change from semester to semester. Students may elect this course several times, provided different topics are studied. Not more than six hours of special topics may be used on a degree program.
Credit 2 hrs May be repeated for additional credit (provided topics are different) Grade Mode Normal (A-F) Course Rotation Irregular Schedule (see Dept.)
Prerequisites - Restriction by Major - Restriction by Degree Type -
COT 700 Introduction to the Interdisciplinary Study of Technology
This course severs as an introduction to the interdisciplinary study of technology by acquainting students with science, technology and society (STS) studies, and with technology philosophies and theoretical paradigms such as social constructivism, scientific rationalism, technological determinism, appropriate technology, technology ethics and socio-technological systems theory. Students will apply these theoretical and analytical concepts to the study of technological systems.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation
Prerequisites - Restriction by Major -Technology [Ph.D.] Restriction by Degree Type -
This course exposes students to cutting-edge technological trends and issues in a variety of scientific and industrial fields through reading and guest lectures by campus experts. Students will have an opportunity to conduct in-depth examinations of selected topics presented, and may use this research as an opportunity to identify or refine potential dissertation topics by linking them to the most current research in a given field of study.
Credit 3 hrs May not be repeated for additional credit Grade Mode Normal (A-F) Course Rotation
Prerequisites -COT 700, May be taken concurrently. Restriction by Major -Technology [Ph.D.] Restriction by Degree Type -
In this course, the need for technology planning is conveyed, as it applies to organizations and society. At the organizational level, principles of strategic planning are reviewed, the business strategies of well-known companies are studied and a case is made for the needed linkage between strategic business planning and technology planning. In this course, students are introduced generally to the technology “life cycle” concept, and the importance of planning to effective technology utilization.
Credit 3 hrs May be repeated for additional credit Grade Mode Normal (A-F) Course Rotation
Prerequisites -COT 700, May be taken concurrently. Restriction by Major -Technology [Ph.D.] Restriction by Degree Type -