Past Education Sessions 2018

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• Regulatory aspects of Clinical Research with minors
• Protocol Adherence
• Safety Considerations
• Study Visits

Presenters

Juanita Cuffee, MPH, CCRP, Pediatric Hematology/Oncology
Rose Cunnion, CCRC, Pediatric Pulmonology
Chayla Hart, Division of Pediatric Endocrinology

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This course is designed for research staff who create and perform informed consent in order to increase understanding of:

• The purpose of informed consent in research
• The various aspects of the informed consent process
• What elements must be included in the informed consent document
• How to conduct an informed consent discussion that meets GCP standards

Presenter

Catherine FB Barnes, BA, CCRP

This course is designed for research staff who perform coverage analysis in order to increase understanding of:

• Medicare regulations regarding research billing in clinical trials
• How to analyze the study protocol schedule of events as it relates to the billing calendar
• Hospital and professional coding for charge capture in a clinical trial

Presenter

Andrea Eiring, MSM, CCRA, CPHRM

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• Increase awareness of the types of medical emergencies that study coordinators may encounter in the research setting
• Identify ways to access medical support to aid research subjects in a medical emergency
• Identify resources available to study coordinators to obtain training in medical emergencies

Presenters

Marie Rape, BSN, RN, CCRC
Laura Tuttle, MA, CCRP
Chayla Hart, BA
Janette Goins, RN, BSN

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• Define Sensitive Information
• Appropriate data collection, use, sharing and storage methods in research
• Discuss NC ID Theft Protection Act
• Review Case studies

Presenters

Micki Jernigan, JD, MPH, CHC, CHPC
Larry Fritsche, CISSP
Ken Langley, BS

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BRIC Services slides

• Risks of medical imaging involving ionizing radiation
• Requirements for studies involving imaging at UNC, including SOPs and the IRBIS application
• Facilities and resources available at the UNC Biomedical Research Imaging Center

Presenters

J. Keith Smith, MD, PhD
Terry Hartman, MPH, MS, CCRC
Angela Creighton, MBA

Objectives:

• Explain rules on usage of Happy Together and how to navigate through screens
• Describe how recruitment through MyChart works and how to apply for phase two pilots
• Explain the coordinator’s role in getting consents scanned into the EMR
• Recall procedures for keeping front desk aware of co-pay status for appointments
• Be able to request options for results routing if needed by your research team

Presenters

Ed Finerty, M.Ed
Stephanie Mascaro

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• Risks of medical imaging involving ionizing radiation
• Requirements for studies involving imaging at UNC, including SOPs and the IRBIS application
• Facilities and resources available at the UNC Biomedical Research Imaging Center

Presenters

Mike Matamoros, MS, CIP
John Roberts, CIP

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• Identify common findings found in research study reviews conducted by the CTQA Program
• Understand what findings require an action plan vs. a corrective and preventative action (CAPA) plan
• Explain what is needed to create an effective CAPA

Presenter

Jamie Kauwell