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Handouts

P1 Compliance within Your HRPP

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P2 Uniform Guidance 101

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P3 Sharpening Research Compliance: Heightened Awareness with a Self-Guided Risk Assessment

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P4 Identifying and Managing Physician Conflicts of Interest in the Research Context

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General Session: Research Year in Review

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101 Demystifying Human Subjects Research Versus Quality Improvement: A Compliance Case Study

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102 Tricky Clinical Trial Budget and Research Billing Compliance Issues Inherited from Mergers & Acquisitions

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103 Navigating Federally Sponsored Projects Abroad: Common Compliance Challenges and Solutions

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201 The Intersection of Clinical Data Management and HIPAA: How to Assess Privacy and Information Security Compliance of Clinical Data

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202 Research Privacy and Security Considerations Beyond HIPAA: What are the Compliance Concerns?

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203 From Paper to Electronic: Evolution of an IACUC Protocol Management System

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301 Clinical Trials Compliance: Collaboration Builds Effectiveness

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302 Compliance through Collaboration: Partnering with Independent IRBs to Develop and Maintain a Strong Human Research Protection Program (HRPP)

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303DG Adapting to New Hazardous Drug Requirements in Research Settings

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401 Exploring Observational Registries and Human Subject Research. Progress Where Ambiguity is the Only Constant

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402 Demystifying Partial Waivers of Consent and Authorization

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403DG Thorny Clinical Research Billing and Coverage Issues

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General Session: Reflecting on the Revised Common Rule: Lessons Learned and Deep Thoughts

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General Session: HHS OIG and Research Compliance

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501 ClinicalTrials.gov: Oversight and Compliance at a Diverse Academic Research Center

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502 Research PHI in the Cloud: Human Subjects Protection Transformed

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503 Mining the Sunshine Data: Finding Potential Conflicts of Interest

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601 Research Billing Compliance Program — From Zero to 100 in 60 seconds!

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602 GDP – What? How the European Union General Data Protection Regulations Impact Research

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603 Export Controls in Medical Research: Compliance Considerations for International Collaborations

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701 Relying on Someone Else’s IRB: Why, When, and How for Hospitals and Academic Medical Centers

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702 Investigator Initiated Trials (IITs): Addressing the Challenges of Auditing IITs for Compliance and GCP

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703 The Dos and Don’ts of Investigating Research Misconduct Cases

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801 Importance of Ensuring Blockchain Compliance for Your Institution

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802 Dealing with Data: Nontechnical Thoughts Concerning Data Security and Management

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803 Radioactive Drug Research Committees- Do you have one? Do you need one? Do you want one?

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General Session: Case Studies in Clinical Research Billing Risk

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W1 Two Offices Divided by a Common Goal: CoI and IRB Review

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W2 Mindful Cross Training: Framing an Effective Approach in the Present to Assist Your Institution’s Research Compliance Risks for the Future

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W3 Integrating Community Hospital Based Research in a System Wide Network: Just Mix in Compliance, Collaboration, Billing, HIPAA, Central IRB then Stir Until Done

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W4 Stage Two! — Applying Concepts Learned at the HCCA Research Academy over Consecutive Years

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