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Certificate Program

Mission of the Certificate Program: There is a growing need for clinical researchers of all levels to take new discoveries from bench to bed or chair-side. The mission of the NYU College of Dentistry Certificate Program in Clinical Research is to produce entry-level clinical research personnel with a basic understanding of clinical research methodology, administration, ethics, and governing regulations, with a programmatic emphasis on Randomized Controlled Trials. Goals of the Certificate Program: The major functions of the NYU College of Dentistry Certificate Program in Clinical Research are education, simulation, and practice and the goals for each function are defined below:

Education:
To educate students about fundamentals of clinical research, clinical research regulations, and the process of constructing research protocols; to develop relevant skills needed for effective practice of clinical research; and, to maintain an environment conducive to learning and self-evaluation.

Simulation:
To contribute to the advancement of clinical research knowledge and experience through simulation with peers, educators, researchers, and research administrators.

Practice:
To provide relevant working experience in clinical research, research administration, and regulatory oversight.

Competencies of the Certificate Program:

By the end of the Certificate Program in Clinical Research, each graduate will be able to independently:

  • Identify, construct, and analyze the key elements of a randomized controlled trial (RCT), and understand how each element is executed
  • Demonstrate the ability to critically evaluate the clinical research literature from both observational and experimental studies in relation to study design, sample size and power, statistical tests applied, validity of the observed results, and the impact of the study on the field
  • Apply statistical methods to data to test a hypothesis using the appropriate analytical methods and derive valid conclusions
  • Distinguish the elements of ICH-GCP E6 Good Clinical Practice as a format for conducting a clinical trial
  • Define the U.S. Good Clinical Practice regulations and the appropriate federal groups that oversee clinical trials
  • Demonstrate knowledge of the Belmont Report, including the difference between research and therapy, the ethical principles, the characteristics of autonomy, and the special review of vulnerable populations
  • Analyze and evaluate data collection forms (CRFs) and design databases to collect data for a simple clinical study
  • Query and validate data obtained during a clinical study
  • Develop statistical programs that are typically used in industry-based RCTs
  • Demonstrate the ability to analyze the grade level language used in an informed consent form
  • Demonstrate the ability to analyze and evaluate a completed RCT protocol