Jan 21, 2022  
2021-2022 College Catalog 
    
2021-2022 College Catalog
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CRC 110 - Clinical Research Common Terminology

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

Study of common terminology used in clinical research profession in order to properly report adverse events in universally understood terminology. Includes research specific terminology and medical terminology used in order to collect a thorough medical history, during an Adverse Event report, and throughout a clinical trial. Also includes common and medical terminology used in clinical research and other health care professions. In addition, the Medical Dictionary for Regulatory Activities (MedDRA) and the Common Terminology Criteria for Adverse Events (CTCAE) will be explored.

Prerequisite(s): BIO 160IN  or BIO 201IH .
Information: BIO 201IN  may be substituted for BIO 201IH  to meet the prerequisite requirement.


Course Learning Outcomes
  1. Describe the component parts of medical terms using basic prefix, suffix, and combining forms to build medical terms
  2. Relate the terms that describe to the body as a whole to the names, locations and functions of the major organs of the body systems
  3. Describe the terms utilized for the major disease processes including symptoms, diagnosis, diagnostic testing, surgeries, and therapies
  4. Define basic terms and abbreviations used in documenting medical records
  5. Use common terms and abbreviations in documenting medical records related to the major systems of the body
  6. Define the MedDRA System Organ Class and the grading system used in Adverse Event severity.
  7. Define an Adverse Event using the CTCAE guidance
  8. Describe the Activities of Daily Life Instrument

Outline:
  1. Basic Word Structure
    1. Analyze medical words by using the tools of word analysis by dividing them into component parts (prefixes, combining forms, and suffixes)
    2. Medical terms related to the structure and function of the human body (in the context of how the body works in health and disease)
    3. Spelling and pronunciation of medical terminology
    4. Medical words divided into their component parts
    5. Meaning of basic combining forms, prefixes, and suffixes of the medical language
  2.  Prefixes and Suffixes
    1. Define prefixes and suffixes
    2. Analyze words using prefixes and suffixes with combining forms to build and understand terminology
  3. Terms Pertaining to the Body as a Whole
    1. Terms that apply to the structural organization of the body
    2. Body cavities and the organs contained within those cavities
    3. Anatomical and clinical divisions of the abdomen
    4. Anatomical divisions of the back
    5. Terms that describe positions, directions, and planes of the body
    6. Definitions for new word elements, using them to understand new medical terms
  4. Organs of Each System
    1. Disease process and symptoms
      1. Skeletal  System
      2. Muscular System
      3. Nervous System
      4. Respiratory System
      5. Cardiovascular System
      6. Digestive System
      7. Excretory and Urinary System
      8. Endocrine System
      9. Immune and Lymphatic System
      10. Integumentary System
      11. Reproductive System (male and female)
      12. Sensory System
    2. Combining forms and the meaning of the related terminology (using these word parts)
      1. Skeletal  System
      2. Muscular System
      3. Nervous System
      4. Respiratory System
      5. Cardiovascular System
      6. Digestive System
      7. Excretory and Urinary System
      8. Endocrine System
      9. Immune and Lymphatic System
      10. Integumentary System
      11. Reproductive System (male and female)
      12. Sensory System
    3. Application of medical terms for the proper collection of adverse events and medical history
      1. Skeletal  System
      2. Muscular System
      3. Nervous System
      4. Respiratory System
      5. Cardiovascular System
      6. Digestive System
      7. Excretory and Urinary System
      8. Endocrine System
      9. Immune and Lymphatic System
      10. Integumentary System
      11. Reproductive System (male and female)
      12. Sensory System
    4. Special Interest areas:
      1. Congenital, familial, and genetic disorders
      2. Injury, poisoning, and procedural complications
      3. Investigations
      4. Social circumstances
      5. Surgical and medical procedures
  5. Understand the System Organ Class Using the MedDRA System
    1. Discover MedDRA
    2. System Organ Class (SOC)
    3. High Level Group Term (HLGT)
    4. High Level Term (HLT)
    5. Preferred Term (PT)
    6. Lowest Level Term (LLT)
  6. Apply the Medical Terminology to the CTCAE
    1. Locate a medical condition(s) or disorder
    2. Medical terminology within the CTCAE
    3. Severity of the condition or disorder
    4. Activities of Daily Life instrument


Effective Term:
Fall 2016



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