Course Descriptions: Required Courses and Required Elective Courses

Certificate in Clinical Research (10 credits)

*all courses required

CLSCI-DN.7030.1.001
FUNDAMENTALS OF CLINICAL TRIALS I                               

CREDITS: 3

Fundaments of Clinical Trials I is a foundational course introducing students to randomized controlled trials (RCTs). The course covers basic elements of an RCT, formulation of research questions, study populations, power and sample size, randomization and masking, study recruitment and enrollment, industry and regulatory issues, safety and adverse events, compliance and monitoring, and data analysis.

CLSCI-DN.7050.001
FEDERAL REGULATIONS & FEDERAL AGENCIES                 

CREDITS: 2

This course will introduce the regulatory and legal underpinnings that dictate the conduct of human clinical trials and drug and device development in the United States. Topics include US laws and regulations, penalties and debarment, good laboratory practice, toxicology testing, HIPAA regulations, the Declaration of Helsinki, INDs, NDAs, and FDA criteria, drug nomenclature, and regulations regarding medical devices.

CLSCI-DN.7035.001
FUNDAMENTALS OF CLINICAL TRIALS II

CREDITS: 3

The second course in the Clinical Trials sequence, Fundamentals of Clinical Trials 2 is a more advanced treatment to the design, conduct, and analysis of clinical trials. Topics include the drug development process, protocol developments, clinical research budgeting, IRB and informed consent, study monitoring and site initiation visits, safety reporting, audits, and advanced topics in trial design such as adaptive clinical trials.

CLSCI-DN.7080.001
BIOETHICS

CREDITS: 2

This course explores issues about ethics, ethical reflection, and case studies that apply ethical principles and moral reflection to health care research using human participants. This course goes beyond the subjects at an introductory level and facilitates the development of independent effort in the resolution of ethical dilemmas. Moreover, students will gain knowledge about federal regulations and key documents that guide human subjects research in the U.S. and globally. Given that the students enrolled in the course provide a diversity of experience and career focus, the course will develop several lines of thought.  There will be issues relate directly to the ethical aspects of research design, recruitment, and enrollment of subjects into projects. The course will use a textbook and case studies as vehicles to deepen understanding and perspectives about the use of human participants. The course includes special topics like confidentiality, decision-making, informed consent, using confidential information in research, and requirements of the Health Insurance Portability and Accountability Act (HIPAA).

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For further details please contact:

Juliana Cools
Program Coordinator
212.998.9934 (T)
212.995.4317 (F)
jc1290@nyu.edu