Important note to CRRA students:click
here to see a listing of additional required and elective courses.
Master of Science in Clinical Research and Regulatory Administration
CLIN RES 400-0
( Core Course ) Essentials of Initiating Clinical Research
This course provides a comprehensive analysis of the fundamental concepts and activities in the clinical research process. Emphasis is on the regulatory and compliance standards that underscore the clinical research process as well as practical application of international and federal guidelines that govern clinical research activities. This class may be taken as an elective for MQARS.
Fall 2009
CH
Th
7:00 - 9:30 PM
Sec. 50
Wieboldt Hall 721
9/24/09 - 12/3/09
Instructor:
CLIN RES 401-0
( Core Course ) Responsible Conduct of Research
This course examines the primary regulatory and ethical requirements for researchers, research staff members, and for institutions engaged in human, animal, and laboratory research. The course will emphasize the responsibilities of investigators and research staff within the research enterprise. This class may be taken as an elective for MQARS.
Summer 2010
CH
Days: TBA
Time: TBA
Sec. 50
Dates: TBA
Instructor:
TBA
CLIN RES 402-0
( Core Course ) Drug and Device Development
Introduces the rationale for, practical aspects of, and new issues in drug and device development as well as the relevant industry and government policies and regulations. Class topics include: illness targets, unmet medical needs, and the pharmaceutical life cycle; scientific basis of drug development (e.g., drug discovery, pre-clinical drug development, patient studies including clinical pharmacology); protocol and budget preparation; pharmacoeconomics and quality of life; regulatory aspects (FDA, GCP, ICH, QA); pharmacogenetics and information technology; biotechnology and technology transfer; role of academia in drug development. This course was previously advertised as MSCI 303. This class may be taken as an elective for MQARS.
Spring 2010
CH
W
6:00 - 9:00 PM
Sec. 50
3/31/10 - 6/2/10
Instructor:
CLIN RES 403-0
( Core Course ) Clinical Research Design and Methodology
This course explores the application of research design and methodology theories and concepts to the practical conduct of a clinical trial. Topics include: commonly used research designs, methods for randomization and blinding, data collection methods including electronic data capture, implications of design and methodology for clinical trial operations from study initiation to data lock. This class may be taken as an elective for MQARS.
Spring 2010
CH
M
7:00 - 9:30 PM
Sec. 50
3/29/10 - 6/7/10
Instructor:
CLIN RES 404-0
( Core Course ) Regulatory Support and Administration
This course explores federal policies and regulations related to sponsored research and responsible conduct of clinical trials as well as the design of institutional processes and systems for assuring compliance. The focus in this course will be on the roles and responsibilities of research administration and the oversight of sponsored research and clinical trials. This class may be taken as an elective for MQARS.
Winter 2010
CH
M
7:00 - 9:30 PM
Sec. 50
1/4/10 - 3/15/10
Instructor:
LEADERS 481-0
( Core Course ) Foundations of Leadership
The purpose of this course is to identify the fundamental leadership behaviors that enable people to excel in their careers, and to help students apply these behaviors to personal and professional success. The course builds from the basic premise that leadership is learned, and looks at the theory and practice of leadership at the individual and organizational level. The course will explore definitions of leadership, the importance of leadership, leadership styles, the role of vision and integrity, the importance of giving and receiving feedback, how to lead change and solve problems, effective teamwork, and communication strategies. The culmination of the class will be a personal leadership development plan formulated by each student.
