CRC 241IN - Integrative Career Preparation I

1. Perform the key functions required to initiate a clinical trial.
2. Demonstrate problem solving and communication skills in study start-up. 
3. Perform simulated clinical trial functions using real-world platforms and technologies.
4. Apply clinical research regulatory compliance, pharmacology principles, and trial design to practical, real-world scenarios.

1. Orientation & Foundations
   1. Course introduction 
   2. Skills lab expectations
   3. Professional behaviors
   4. Attendance requirements
   5. Review of key regulations (FDA, IND, ICH-GCP basics)
      1. Critique sample essential documents  
2. Regulatory Documentation in Practice
   1. Trial Master Files
   2. Mock master file entry 
   3. IRB Portals
3. Drug Development & Pharmacovigilance I
   1. Drug development stages 
   2. Investigational product lifecycle
   3. Map investigational product journey from bench to approval 
4. Skills Check 1
   1. Regulatory submission
   2. Key regulatory agencies & responsibilities
   3. Informed Consent 
5. Pharmacology Applications in Research
   1. Pharmacokinetics/dynamics applied to protocol development
   2. Analyze patient profiles for drug-drug interactions
6. Pharmacovigilance II: Safety Monitoring
   1. Adverse event types
   2. Reporting timelines 
   3. Safety assessment
7. Skills Check 2
   1. Adverse event case study
   2. Simulate IRB submission meeting
8. Applied Trial Management & Integration
   1. Protocol Design 
      1. Applying objectives, eligibility, procedures
      2. Draft inclusion/exclusion criteria for a protocol
      3. Ethical considerations, participant protections, vulnerable populations
   2. Mock Trial Management
      1. Regulatory submissions 
      2. Documenting and resolving protocol deviations
      3. Protocol case study: identify compliance issues, propose corrective actions