Jul 15, 2024  
2022-2023 College Catalog 
    
2022-2023 College Catalog [ARCHIVED CATALOG]

CRC 250IN - Clinical Research Site Coordination and Trial Implementation

4 Credits, 6 Contact Hours
3 lecture periods 3 lab periods

Knowledge of the operational and clinical steps involved in conducting a clinical trial from study start-up activities through study close-out. Includes Good Clinical Practices (GCP) involving the identification and evaluation of the protocol for feasibility, essential documents and Good Documentation Practices (GDP), Investigational Product management, subject recruitment, safety, and retention, the monitoring plan, and the role of the IRB.

Prerequisite(s): CRC 230 .
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Course Learning Outcomes
  1. Describe the roles and responsibilities of the clinical investigation team as defined by Good Clinical Practice Guidelines
  2. Develop the operational efficiencies necessary to conduct a clinical trial.
  3. Develop a recruitment plan to recruit and retain study subjects
  4. Describe the methods used to identify and manage safety issues.
  5. Develop a management plan for a research site project
  6. Demonstrate maintenance of records for investigational products and research specimens.

Outline:
  1. Study Start-Up Review
    1. Site and Sponsor Feasibility Assessment Procedures
    2. Start Up-Related Meetings and Agreements
      1. Pre-Study Qualification Visit
      2. Site Initiation Visit
      3. Investigator Meeting
      4. Confidentiality Agreements
      5. Clinical Trial Agreements
    3. Planning and Preparation of Research Budgets and Negotiations
      1. Process involved in the development of a research study budget
      2. Routine calculations associated with the costs of a clinical research trial
      3. Assisting in the calculations of an overall research project budget, including personnel costs, overhead, and profit margin
  2. Coordinating a Clinical Research Project
    1. Development of an overall plan for a clinical research project
      1. Elements of Project Management
        1. Developing a detailed plan (including time lines) for each phase of the clinical research project
        2. Effective communication between project team members and clinical trial management
    2. Operational Site Management
      1. Drafting Standard Operating Procedures
      2. Site and Staff Training Procedures and Documentation
      3. Study-related Equipment Maintenance
      4. Implementing Corrective and Preventive Action Plans
    3. Mitigating problems that can commonly occur between clinical research sites and Sponsors/Contract Research Organizations
    4. Recruitment, Enrollment and Retention of Study Subjects
      1. Subject recruitment plan 
      2. Required IRB Approvals of Advertisement Materials
      3. Informed Consent Procedures
    5. Study Participant Visits
      1. Data Collection and Management
        1. Characteristics of high-quality data
        2. Good Documentation Practices and ALCOA+
      2. Preparation and maintenance of Data
        1. Standard of Care vs. Study specific data
        2. Protocol Timeline
        3. Source documentation and review process
        4. Case report form completion, corrections, errors
        5. Collection of specimens for submission to central collection laboratories
        6. Investigational Product Maintenance
        7. Monitoring dosage modifications and treatment calculations for compliance
        8. Identifying and reporting adverse events
        9. Quality controls and audits
      3. Adverse Events and Reporting
        1. AE, SAE, and Events of Interest
        2. UADE, SUSAR
        3. Process for capturing and assessing AE
        4. Investigator oversight
        5. Reporting and Follow-up
    6. Application of Regulatory, Legal, and Governing Parameters with a Clinical Research Project
    7. Investigational Product Control, Storage, and Dispensing.
      1. Safety Profile of IP
      2. Proper storage, dispensing, and handling of IP
      3. Proper IP destruction procedures
      4. Applicable State and Local Regulations
      5. When IP becomes compromised.
    8. Site Master Files
      1. Essential document checklist
      2. Administrative vs. Patient-related Essential Documents
      3. Source Documents and Case Report Forms
    9. Monitoring Visits
      1. Monitoring Plan
      2. Source Data Verification
      3. Interim Monitoring Visits
      4. Risk-Based Monitoring Approaches
      5. Monitoring letters
      6. Protocol Deviations and Violations
      7. Data Queries and Corrections
      8. Misconduct and Fraud
  3. Study Close-Out Procedures
    1. Communication to Participants
    2. Communication to IRB
    3. Communication to Sponsor/CRO