Monday, October 16, 2023 |
10:00 AM - 11:00 AM | Clinical Trials Research: Medicare Coverage Analysis (Beginner – Intermediate) | Billing Compliance |
10:00 AM - 11:00 AM | Creating & Using a CTA Playbook: Basic | Contracts |
11:00 AM - 11:15 AM | Win $20! QUIZ BREAK | |
11:15 AM - 12:15 PM | Fair Market Value in Clinical Research Budgets (Beginner – Advanced) | Billing Compliance |
11:15 AM - 12:15 PM | Those Devilish Details: Keywords & Phrases in Clinical Trial Agreements | Contracts |
12:15 PM - 1:15 PM | LUNCH BREAK | |
1:15 PM - 2:15 PM | Site/Sponsor Relationships: "Getting to YES" (Beginner to Intermediate) | Budgets |
1:15 PM - 2:15 PM | Incorporating Project Management into Clinical Trial Operations: Best Practices | Clinical Operations |
1:15 PM - 2:15 PM | Ethical Considerations for Including Children in Research | Quality / Regulatory |
2:15 PM - 2:30 PM | BREAK | |
2:30 PM - 3:30 PM | Budget Development for Sites (Beginner – Intermediate) | Budgets |
2:30 PM - 3:30 PM | The What, How and Where of Data: A Regulatory Overview | Clinical Operations |
2:30 PM - 3:30 PM | The Art of Informed Consent | Quality / Regulatory |
Tuesday, October 17, 2023 |
10:00 AM - 11:00 AM | Indemnification: Basic | Contracts |
10:00 AM - 11:00 AM | Research Billing Compliance: Monitoring & Auditing (Intermediate – Advanced) | Billing Compliance |
11:00 AM - 11:15 AM | Win $20! QUIZ BREAK | |
11:15 AM - 12:15 PM | Insurance (Intermediate - Advanced) | Contracts |
11:15 AM - 12:15 PM | Research Compliance: Anti-Kickback, Stark, & False Claims (Beginner – Intermediate) | Billing Compliance |
12:15 PM - 1:15 PM | LUNCH BREAK | |
1:15 PM - 2:15 PM | Hidden Costs for Sites & Sponsors (Beginner – Intermediate) | Budgets |
1:15 PM - 2:15 PM | Effective Risk Management in Complex Clinical Trials | Clinical Operations |
2:15 PM - 2:30 PM | BREAK | |
2:30 PM - 3:30 PM | How to Explain Study Costs & Billing to Patients (Beginner – Advanced) | Budgets |
2:30 PM - 3:30 PM | Health Equity and Clinical Research: Addressing Disparities in Access and Outcomes | Clinical Operations |
2:30 PM - 3:30 PM | Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Myths & Fine Points | Quality / Regulatory |
Wednesday, October 18, 2023 |
10:00 AM - 11:00 AM | Take Back Control of Your Workload! Project Management and Negotiation Tools for Contract Negotiators | Contracts |
10:00 AM - 11:00 AM | Operationalizing Your Billing Compliance Program (Intermediate – Advanced) | Billing Compliance |
11:00 AM - 11:15 AM | Win $20! QUIZ BREAK | |
11:15 AM - 12:15 PM | AI for Patient Recruitment: Establishing a Return on Investment | Clinical Operations |
11:15 AM - 12:15 PM | Data Protection (Regulatory Aspects): Intermediate/Advanced | Contracts |
12:15 PM - 1:15 PM | LUNCH BREAK | |
1:15 PM - 2:15 PM | Clinical Research Site FDA Inspections (Part 1) | Quality / Regulatory |
1:15 PM - 2:15 PM | Change Management 101: Capturing and Maintaining Your Best Version of Clinical Trial Operations | Clinical Operations |
1:15 PM - 2:15 PM | Collecting Payments From Sponsors: Tips & Tricks (Beginner – Intermediate) | Budgets |
2:15 PM - 2:30 PM | BREAK | |
2:30 PM - 3:30 PM | Current Topics in Clinical Trial Participant Recruitment: Strategies for Clinical Trial Optimization | Clinical Operations |
2:30 PM - 3:30 PM | Clinical Research Site FDA Inspections (Part 2) | Quality / Regulatory |
Thursday, October 19, 2023 |
10:00 AM - 11:00 AM | When CROs Negotiate the CTA & Budget: Basic (Panel Discussion) | Contracts |
10:00 AM - 11:00 AM | Medical Device Trials: Similarities and IMPORTANT Differences (Beginner – Advanced) | Billing Compliance |
11:00 AM - 11:15 AM | Win $20! QUIZ BREAK | |
11:15 AM - 12:15 PM | Should We "Bill to Sponsor if Denied by Insurance?" (Intermediate – Advanced) | Billing Compliance |
12:15 PM - 1:15 PM | LUNCH BREAK | |
1:15 PM - 2:15 PM | Informed Consent – Best Practices for Quality Conduct of Research | Quality / Regulatory |
1:15 PM - 2:15 PM | A Closer Look at DEI and Its Present and Future Impacts on Clinical Research | Clinical Operations |
1:15 PM - 2:15 PM | Constructive Tactics for Effective Budget Negotiation (Beginner – Intermediate) | Budgets |
2:15 PM - 2:30 PM | BREAK | |
2:30 PM - 3:30 PM | Monitoring Fees: On Site vs Remote… Let's Get Into It (Panel Discussion) (Intermediate – Advanced) | Budgets |
2:30 PM - 3:30 PM | ICH E6 (R3) – A Big Step Forward for the Future of Clinical Trials | Quality / Regulatory |
2:30 PM - 3:30 PM | Patient-Centric Clinical Trials: Enhancing Engagement and Experience (Panel Discussion) | Clinical Operations |
Friday, October 20, 2023 |
10:00 AM - 11:00 AM | Cybersecurity (IT Measures): Intermediate/Advanced | Contracts |
11:00 AM - 11:15 AM | Win $20! QUIZ BREAK | |
11:15 AM - 12:15 PM | Medicare Coverage Analysis: Out of the Ordinary (Beginner – Advanced) | Billing Compliance |
11:15 AM - 12:15 PM | Site, Sponsor, and CRO Metrics and Benchmarking | Contracts |
12:15 PM - 1:15 PM | LUNCH BREAK | |
1:15 PM - 2:15 PM | Quality Assurance and Associated Challenges at the Resource Limited, Rural Research Site | Quality / Regulatory |
1:15 PM - 2:15 PM | Methodology for Measuring, Budgeting, and Managing Site Staff Workload (Intermediate – Advanced) | Budgets |
1:15 PM - 2:15 PM | Key Performance Indicators for Site-Sponsor-CRO Relationships | Clinical Operations |
2:15 PM - 2:30 PM | BREAK | |
2:30 PM - 3:30 PM | Digital Transformation in Clinical Trials: Streamlining Processes and Data Management | Clinical Operations |
2:30 PM - 3:30 PM | Professional Growth and Career Development for the Clinical Research Professional | Clinical Operations |
2:30 PM - 3:30 PM | Study Budget - All Parties (Panel Discussion) (Beginner – Advanced) | Budgets |