Apr 14, 2026  
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2026-2027 College Catalog

CRC 151 - Introduction to Clinical Research

3 Contact Hours, 3 Credits
3 lecture periods 0 lab periods


Introduction to the history and evolution of clinical research. Includes the human subject protections, drug study classifications, national & international regulations, and clinical research team roles and responsibilities.

Recommendation: Completion or concurrent enrollment into CRC 100 .
Information: Students must be admitted to or have conditional status of the Clinical Research AAS or Post-Degree Certificate program or obtain the consent of the instructor before enrolling in this course.
Button linking to AZ Transfer course equivalency guide  

Course Learning Outcomes
  1. Explain the evolution and history of the protection of human subjects in clinical trials.
  2. Identify the principles of the key historical documents that ensure the protection of human participants in clinical trials.
  3. Describe the strategies for identifying, recruiting and retaining study subjects.
  4. Describe the classification of clinical trial designs in phases I through IV.
  5. Identify the necessary skills and attributes of the clinical research professional.
Performance Objectives:
  1. Identify necessary skills and attributes of the clinical research coordinator (CRC) and clinical research professional (CRP).
  2. Assess personality traits to the skills and attributes of the CRC and CRP.
  3. Prepare a recruitment plan for a mock clinical trial.
Outline:
  1. Evolution and History of Clinical Research 
    1. World War II Human Experiments
    2. Nuremberg Code
    3. Declaration of Helsinki
    4. Belmont Report      
  2. The Protection of Human Subjects in Clinical Research 
    1. FDA and Good Clinical Practices
    2. Informed Consent
      1. Elements of consent: Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) and International Community for Harmonization (ICH)
      2. Comprehension
      3. Autonomy vs. coercion
      4. Documentation
      5. Exceptions to consent
      6. Health Insurance Portability and Accountability Act (HIPAA) compliance
    3. Institutional Review Boards and Ethics Committees
    4. Safety Measures in Clinical Trials.
    5. Recruitment and Retention of Study Participants
  3. Components of Clinical Trial Designs for Phases I through IV
  4. Members of a Clinical Research Study Team: Roles, Responsibilities and Interdependencies
    1. Clinical research coordinator
    2. Project leader/manager
    3. Clinical investigator
    4. Clinical research associate/monitor
  5. Professional Research Associations and Their Respective Roles 
    1. Society of Clinical Research Associates (SoCRA)
    2. Association of Clinical Research Professionals (ACRP)
    3. Drug Information Association (DIA)
    4. Regulatory Affairs Professional Society (RAPS)
    5. Society of Clinical Data Management (SCDM)