CRC 230 - Introduction to Clinical Research Study Protocol

1. Explain Inclusion/Exclusion criteria
2. Explain the difference between standard of care and trial activities in relation to protocol
3. Differentiate among the various types of research designs and concepts, including the protocol elements used in each design.
4. Compile the Regulatory requirements for study start-up.
5. Develop an Informed Consent Form using the Research Protocol.

1. Explain the study background and rationale for a clinical trial
2. Explain the purpose of an Investigators Brochure and instructions for use
3. Describe the key elements contained within essential documents
4. Identify the study hypothesis, objectives, and endpoints for a variety of clinical trials
5. Explain professional guidelines and code of ethics as they apply to the role of the CRC

1. Scientific Approach Applied to Development of Research Protocol
   1. Overall process of clinical research development
   2. Classifications of clinical trial designs in Phases I-V
   3. Regulatory requirements for protocol development as specified in the FDA regulations, IND and ICH guidelines
   4. Development of appropriate research hypotheses specific to each phase of protocol development
2. Key Elements Addressed in a Research Protocol
   1. Background information including a synopsis of the properties of the investigational product
   2. Study objectives and purpose
   3. Study design
   4. Selection of subject and precedent for subject withdrawal
   5. Study procedures and treatment of subjects
   6. Efficacy methods and assessment parameters
   7. Safety assessment parameters
   8. Statistical methods to be used in analyzing data
   9. Statement concerning direct access to source data and documents
   10. Quality control and quality assurance methods
   11. Ethical concerns related to the study including informed consent
   12. Data handling methods
   13. Indemnification statement, insurance requirements and financial arrangements with investigator
   14. Statement of sponsor’s publication policy
   15. Protocol amendments
3. Research Designs and Concepts
   1. Types of research designs
   2. Types of control groups
   3. Ways to randomize for a clinical trial
   4. Ways to blind a clinical trial
   5. Control of bias in clinical trials
4. Ethical Considerations and Issues
   1. Ethical principles consistent with Good Clinical Practices (GCP) and Federal Regulations
   2. Scientifically sound hypotheses and treatment procedures
   3. Rights of study subject
   4. Foreseeable risks and unexpected events
   5. IRB approval and the informed consent process
   6. “Unblinding” rules and procedures
   7. Scientific misconduct
5. Identify the Differences in Study Design Approaches
   1. Prospective
   2. Retrospective
   3. Combination