CRC 273 - Clinical Trial Operations

1. Describe the necessary steps to implement a clinical trial.
2. Describe the elements of a study budget as it relates to the execution of a protocol.
3. Explain the variety of electronic clinical technologies and tools used to automate, enhance, and streamline clinical study conduct.
4. Describe the Management and Training approaches to mitigate risk during a clinical trial.
5. Identify the legal responsibilities and accountabilities of conducting a clinical trial.

1. Implementing a Clinical Trial
   1. Site and Protocol Feasibility
   2. Site Approval Processes
   3. SOPs
   4. Approval from Stakeholders
2. Developing a Research Study Budget
   1. Developing a Study Plan
   2. Elements of a Study Budget and the Protocol
      1. Estimating study costs and a site budget
      2. Analyzing the budget components for a specified clinical trial relative to cost effectiveness
      3. Third Party Vendors, Certificates, and Credentials
      4. Assisting in the calculations of an overall research project budget, including personnel, costs, overhead, and profit margin
      5. Components of a typical bid, proposal, and contract
3. Management and Training Approaches  to mitigate risk
   1. Delegation of Responsibility
      1. Roles of Study Team Members
      2. Staff Qualifications
      3. Training and Documentation
      4. Updating the Delegation Log during the trial.
   2. Corrective and Prevention Action Plans
      1. Risk Assessment
      2. Root Cause Analyses
   3. Implementation Analysis and Operational Considerations
      1. Site recruitment and selection
         1. Dedicated Personnel
         2. Advertising Strategies
         3. Pre-Screening and Screening Strategies
      2. Investigational product shipment and storage
         1. Procedures for accepting IP
         2. Storage considerations
         3. Product Accountability
         4. Participant Instructions
         5. Quarantine Considerations
   4. The well-coordinated research project
      1. PI Oversight
      2. Study Procedures
         1. Administrative
         2. Clinical
      3. Training
         1. Implementation
         2. Record-keeping
      4. Maintenance of Facilities
         1. Safety
         2. Ergonomics
      5. Equipment
         1. Maintenance and Calibration Records
         2. Inventory
      6. Office and Clinical Supplies
      7. Data Collection and Entry
         1. Personnel and Responsibilities
         2. Timeliness of Data Entry
         3. Queries
         4. Good Documentation Practices
      8. Trial Compliance
         1. IRB
         2. DSMB
         3. FDA 
4. Legal Responsibilities, Liabilities, and Accountabilities  
   1. Clinical Trial Agreement (CTA)
      1. Execution of the CTA and the trial.
      2. Insurance or Indemnification and the CTA
      3. Mitigating Risk and Liabilities
         1. Business Risks
         2. Regulatory Sanctions
         3. Civil Penalties
         4. Criminal Prosecution