2018 Research Compliance Conference
Austin, TX, United StatesHandouts
P1 | Operationalizing Government Corrective Action Plans: Aftermath of an OCR Investigation
Presentation (2 slides/page) |
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P2 | Clinical Research Billing Audits: It’s (Almost) All in the Planning!
Presentation 1 (2 slides/page) Presentation 2 (2 slides/page) |
P3 | Corrective and Preventive Actions (CAPA) Plans that Guide Clinical Research Professionals in Improving Weaknesses, Deficiencies, or in Rectifying Deviation Patterns and Areas of Noncompliance
Presentation (2 slides/page) |
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P4 | Transforming a Community Health-Based Research Organization: Strategy and Lessons Learned
Presentation (2 slides/page) |
General Session 1 | Research Year In Review
Presentation (2 slides/page) |
101 | Turn On, Tune In, Collect Data: Conducting Clinical Investigations with Controlled Substances
Presentation (2 slides/page) |
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102 | PI Compensation: Compliant Methods, Documentation, and Execution
Presentation (2 slides/page) |
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103 | Anatomy of a Research Misconduct Issue
Presentation (2 slides/page) |
201 | Community Hospital Research Programs: A Compliance Officer’s Friend or Nightmare
Presentation (2 slides/page)
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202 | Strategies to Effectively Monitor Researchers’ Access to the EMR
Presentation (2 slides/page) |
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203 | An Integrated Model for Building and Maintaining an Effective Research Compliance Program in an Academic Research Center
Presentation (2 slides/page) |
301 | Optimizing Research Compliance within the Electronic Health Record (EHR) System
Presentation (2 slides/page) |
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302 | Conflict of Interest 2.0: Beyond Data Collection
Presentation (2 slides/page) |
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303AD | Thorny Clinical Research Billing and Coverage Issues
No presentation or handouts available |
401 | Research Compliance Risks and HIPAA Privacy Pitfalls in a Healthcare Academic Setting
Presentation (2 slides/page) |
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402 | Integrating Research Integrity with Corporate Compliance
Presentation (2 slides/page) |
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403 | Getting to Compliant: Personal Protective Equipment Use in the Non-Clinical Research Setting
Presentation (2 slides/page) |
General Session 2 | Whistleblowers in the Research Setting
Presentation (2 slides/page) |
General Session 3 | The Revised Common Rule: What Should We Do NowThe past few years have seen a previously-unprecedented level of change to Federal statutes, regulations, and policies applicable to human subjects research. These include the substantial changes to the “Common Rule,” the Federal regulations that protect human subjects in research. The session will:
Presentation (2 slides/page) |
501 | It All Starts in a Lab! Laboratory Issues and the Research Regulatory Environment
Presentation (2 slides/page) |
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502 | Implementing a Research Compliance Program in a Large National Healthcare System
Presentation (2 slides/page) |
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503 | The Tissue Issue: Perspectives on Protection and Privacy Issues in Data/Tissue Repositories
Presentation (2 slides/page) |
601 | 601 Conflict of Interest: Is it My Problem or Yours?
Presentation (2 slides/page) |
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602 | Self-Imposed Regulatory Burden in Animal Research Oversight
Presentation (2 slides/page) |
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AD603 | FDA Compliance at-a-Glance
No presentation or handout available |
701 | Strategies to Promote Physician Investigator GCP Compliance
Presentation (2 slides/page) |
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702 | Does the Thought of International Research Keep You Up at Night?
Presentation (2 slides/page) |
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AD703 | The IRB and Research Compliance: A Crucial Partnership
No presentation or handout available |
801 | Auditing in a Post–Common Rule World
Presentation (2 slides/page) |
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802 | Outcome Unknown: The Ethics and Mechanics of Informed Consent in Research Involving Genomics, Questionable Pre-clinical Results, and the Risk of Death
Presentation (2 slides/page) |
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803 | Facilitating Compliance with 21 CFR Part 11
Presentation (2 slides/page) |
General Session 4 | Clinical Trial Agreements and Unintended Compliance Issues
Presentation (2 slides/page) |
W1 | A Case Study of the Implementation Process
Presentation (2 slides/page) |
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W2 | Grant Compliance for Dummies
Presentation (2 slides/page) |
W3 | Patient Privacy In Research Under HIPAA and the Additional HIPAA and Privacy Issues Related to Big Data Sets
Presentation (2 slides/page) |
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W4 | Dissecting the Clinical Trial Agreement: Avoiding Compliance Pitfall in Clinical Trial Agreements
Presentation (2 slides/page) |