CRC 201 - Clinical Research Regulatory Compliance

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


Strengthens regulatory framework concepts in clinical research and their influence on research practices, ethical standards, and scientific reliability of clinical trials. Explores research monitoring and the function of audits and investigation in safeguarding compliance. Concludes with a comprehensive understanding of the systems and structures that uphold participant protections and research integrity.

Prerequisite(s): CRC 151  
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.
    

1. Discuss the historical events that precipitated the development of governmental regulatory processes for investigational products
2. Explain the responsibilities of an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
3. Describe the role of the Data Safety and Monitoring Board during a clinical trial.
4. Differentiate between a sponsor audit, an IRB audit, and an FDA inspection
5. Apply the ICH GCP Guidelines to Clinical Trials

1. History and Evolution of the FDA

2. Key Events in in the history of the FDA
   1. Kefauver-Harris Amendment for Drug Development
   2. The Tuskegee Syphilis Study
   3. The National Research Act
   4. The Belmont Report
3. Code of Federal Regulation for the Conduct of Clinical Research and Human Subject Protections
   1. Title 21
   2. Title 45
4. Department of Health and Human Services
   1. CBER
   2. CDER
   3. CDRH
5. The FDA’s role in Public Health
   1. Introduction of Drug and Device Development 
   2. Drug and Device Approval Process
6. The Institutional Review Board
   1. Human Subject Protections
   2. Oversight of Human Research Projects
   3. Introduction to Recordkeeping and Data Integrity
   4. Introduction to the IRB Reporting
7. Risk Assessment and Safety Management
   1. Informed Consent
      1. Mitigating Bias
      2. Mitigating Coercion
   2. HIPAA and PHI
   3. Confidentiality
   4. Introduction of the Data Safety Monitoring Board
8. Audits and Inspections
   1. The Role of the CRA
   2. Introduction to Recordkeeping and Data Integrity
      1. Good Documentation Practices
   3. Reporting Requirements
   4. Quality Assurance Procedures