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Course Descriptions

CRSC 1010 — Foundations of Clinical Research I: Concepts and Theories (fall)

Students will learn about:

  1. The history of research, terminology and steps in the research process
  2. Research questions relevant to clinical practice
  3. Interpretation of research for use in practice, and the role of ethics in the conduct of research

CRSC 1100 — Legal and Regulatory Research Compliance in Clinical Research (fall)

Students will learn about:

  1. The functions of the research regulatory agencies at the institutional, state and federal levels
  2. The purpose and function of the Institutional Review Board (IRB)
  3. The International Conference on Harmonization (ICH)
  4. Good Clinical Practice (GCP) guidelines for clinical research
  5. Regulatory guidelines for the informed consent process
  6. Issues related to confidentiality in research
  7. The purpose of a Data and Safety Monitoring Plan (DSMP) and Data and Safety Monitoring Board (DSMB)
  8. Issues related to conflict of interest and ethical conduct of research
  9. Where to find and how to apply Health Insurance Portability and Accountability Act (HIPAA) rules and regulations for research

CRSC 2010 — Foundations of Clinical Research II: Applications (spring)

Students will learn about:

  1. Common definitions of terms specific to clinical research
  2. How to explain the function and role of the clinical research coordinator and the investigative team
  3. Critical thinking and problem-solving skills to explore and discuss the moral and ethical conduct of clinical research personnel
  4. The clinical research grant process

CRSC 2100 — Clinical Research Site Management (spring)

Students will:

  1. Gain a broad understanding of clinical research site management, including regulatory documents, budgeting and contracting, informed consent, auditing, safety monitoring, data collection, site closure, and updates on the clinical trials environment
  2. Experience the process of preparing, implementing and closing the clinical research trial
  3. Learn how to complete and manage common forms and documents needed to implement and manage a clinical research trial

CRSC 3000 — Fieldwork (arranged)

The internship gives students 480 hours of fieldwork experience under the mentorship of an experienced research preceptor.

During the fieldwork experience, students will be exposed to a variety of clinical research coordination activities, including (but not limited to) the informed consent process, budget activities, recruitment, data collection, research documentation procedures, study management and auditing.

  • April 20, 2012
  • ART642964