CRC 276IN - Integrative Career Preparation II

4 Contact Hours, 2 Credits
1 lecture periods 3 lab periods

Career preparation combining clinical research coordination, trial operations, data collection management and clinical skills. Includes the application of clinical trial practices and procedures to real-world scenarios. Also includes the clinical and operational aspects of conducting a clinical trial once it is underway. Includes practice participant recruitment and retention strategies, data collection and management procedures, and effective use of electronic clinical trial management systems. Also includes Good Clinical Practice standards and operational workflows while maintaining participant safety and data integrity.

Prerequisite(s): CRC 241IN
Information: Students must be admitted to the CRC AAS or CRP Post-degree certificate program or obtain consent of the CRC Department before enrolling in this course.

Course Learning Outcomes

Simulate the recruitment, enrollment, and retention procedures for a clinical trial.
Apply data management principles using good documentation practices (GDP) during a clinical trial project.
Perform specimen handling procedures in alignment with clinical trial protocols and quality assurance standards.
Collaborate in team-based trial scenarios by integrating site coordination, data management, clinical trial operations and specimen handling into cohesive study workflows.

Outline:

Orientation & Foundations
1. Course introduction
2. Course expectations
3. Professional expectations in operations/data roles
4. Introduction to trial documentation workflow
  1. Review mock source documents mapping to CRFs
Data Entry & Query Resolution
1. Data capture systems
2. Common errors
3. Query management
4. Mock patient data entry
5. Mock responding to system-generated queries
Data Quality & Integrity
1. Applying Good Documentation Practices
2. Audit Trails
3. Patient Confidentiality Application
4. Mock Audit of CRFs for Compliance
Skills Check
1. Individual eCRF entry + query resolution exercise
2. GDP principles + confidentiality safeguards
3. Team exercise: Screening Visit
  1. Binder Review
  2. Recruitment Plan
  3. Data Collection
  4. IP handling
4. Individual mock AE documentation
5. Individual: Perform simulated blood draw with specimen labeling & processing
6. Written: Reflection on phlebotomy errors and corrective actions
7. Individual: Study Visit data collection, source documentation, eCRF entry
8. Team: End-to-end trial simulation presentation (start-up, recruitment, AE reporting, monitoring, close-out)
Site Documentation & Regulatory Binders
1. Source Documentation
2. Delegation Logs
3. IMP logs
4. Patient logs
5. Mock site reg binder update
Recruitment, Consent & Retention
1. Applying recruitment strategies
2. IRB submission
3. Informed Consent
4. Retention strategies
Investigational Product & Safety Documentation
1. IMP management
2. Accountability logs
3. AE documentation
Trial Operations & Phlebotomy Integration
1. Clinical Trial Operations
  1. Budgeting
  2. Contracts
  3. Site Feasibility
  4. Monitoring Plans
  5. SOP’s
  6. Notes to File
  7. CAPA
  8. Mock responding to monitoring findings
  9. Mock invoicing
2. Specimen Processing and Shipping
  1. Specimen Collection practices
  2. Point of Care Testing
  3. Chain of Custody
  4. Specimen Transportation
3. Integrated Operations
  1. Team-based trial simulation
    1. Principal Investigator
    2. Site Manager
    3. Site Coordinator
    4. Data Coordinator
    5. Phlebotomist, Medical Assistant
  2. Close-Out Activities
  3. Data Archival