CRC 255 - Study and Site Coordination

1. Apply the site feasibility process confirming clinical trial readiness.
2. Describe the resources necessary to conduct and manage a clinical trial.
3. Summarize strategies to recruit and retain participants while protecting their rights and safety.
4. Demonstrate site-specific procedural, Good Documentation Practices, and oversight requirements to ensure data integrity.
5. Explain the operational and clinical steps involved in a clinical trial from start-up through close-out.

1. Study Start-Up Review
   1. Site 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
2. 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. Enrollment and Retention of Study Subjects
      1. IRB Approvals of Advertisement Materials
      2. Informed Consent Procedures
   4. 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. Collection of specimens for submission to central collection laboratories
         5. Monitoring dosage modifications and treatment calculations for compliance
         6. Identifying and reporting adverse events
         7. 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
   5. 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.
   6. Site Master Files
      1. Essential document checklist
      2. Administrative vs. Patient-related Essential Documents
      3. Source Documents and Case Report Forms
   7. 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