CRC 101 - Foundations of Clinical Research

1. Explain the evolution of the requirements for informed consent from research participants.
2. Identify the principles and content of the key documents that ensure the protection of human participants in clinical research.
3. Describe the ethical issues and safeguards concerning vulnerable populations.
4. Explain the phases and purposes of clinical studies as part of the drug development process.
5. Identify and apply the professional guidelines and code of ethics that apply to the conduct of clinical research.

1. Identify necessary skills and attributes of the clinical research coordinator (CRC).
2. Prepare an organizational chart depicting a typical research team.
3. Identify medical, pharmaceutical, and research related terminology and acronyms

1. Evolution and History of Clinical Research and the Protection of Human Subjects in Clinical Research 
   1. Tuskegee Syphilis Study
   2. World War II human experiments
   3. Nuremberg Code
   4. Human Radiation Experiments
   5. 1960’s Thalidomide Tragedy
   6. Kefauver-Harris Amendment
   7. Milgram Study
   8. Declaration of Helsinki
   9. Beecher article, New England Journal of Medicine
   10. Belmont Report
   11. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical/Behavioral Research
   12. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
   13. Sub-committee on Health and Science               
2. Evolution and History of the Clinical Research Process
   1. U.S. laws governing the development and marketing of drugs and devices
   2. Bioresearch Monitoring Program
   3. Federal regulations and International Community for Harmonization (ICH) guidelines
3. Overall Process of Clinical Research Development of Drugs, Devices and Biologics
   1. Government agencies and international initiatives involved in clinical research
   2. New drug and biologic development and marketing approval process
   3. Medical device development and marketing approval process
4. 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
5. Components of Clinical Trial Designs for Phases I through IV
6. Selected Common Medical and Pharmacologic Terms Used in Clinical Research
   1. Identification
   2. Definition
   3. Abbreviation
   4. Appropriate utilization of common medical terms and abbreviations
7. Members of a Clinical Research Study Team: Roles, Responsibilities and Interdependencies
   1. Study coordinator
   2. Clinical pharmacist
   3. Statistician
   4. Project leader/manager
   5. Auditor
   6. Clinical investigator
   7. Clinical research associate/monitor
   8. Data manager
   9. Medical officer
   10. Medical writer
   11. Regulatory affairs personnel
   12. Basic Scientist (Translational research)
   13. Epidemiologist
   14. Contracts and Legal personnel
   15. Quality Control and Quality Assurance officer
   16. Bioinformatics Programmer
8. Skills and Performance Expectations of the Clinical Research Coordinator      
   1. Professional demeanor
   2. Application of knowledge and experience
   3. Team player
   4. Communication skills
   5. Attention to detail
   6. Professional dress
9. Organizations Involved in the Clinical Research Process
   1. Pharmaceutical, biotech and medical device companies
   2. Clinical research organizations
   3. Site management organizations
   4. Institutional review boards
   5. Investigative sites
   6. Academic research organizations
   7. Research laboratories
   8. Research funding agencies (e.g., private foundations, governmental agencies and non-governmental agencies)
   9. U.S. FDA and other regulatory agencies
   10. Data Safety and Monitoring Board
   11. National Institutes of Health
   12. National Cancer Institute
10. Basic Clinical Trial Ethical Considerations in the Conduction of a Clinical Trial
    1. Pre-trial Ethical considerations
       1. Study design
       2. Selecting a comparison treatment or intervention
       3. Randomized trials
       4. Inclusion/exclusion criteria
       5. Working with vulnerable populations
    2. Ethical considerations during trial
       1. Recruitment
       2. Barriers to recruitment
       3. Confidentiality and privacy
       4. Compensation for research-induced injury
       5. Monitoring the study
       6. Issues relating to confidentiality and disclosure
    3. Post-Trial ethical considerations
       1. Authorship
       2. Obligation to inform
11. 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)