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  • Monday, Dec 4th
    1:00 PM – 2:00 PM ET
    A09 - [IN-PERSON ONLY] Designing and Implementing Quality Control (QC) for your Research Compliance Program
    Location: Room 150 AB
    Speaker: Alan Teller, CIP – Yale University
    Speaker: Paul Lees (he/him/his) – OHRP
    Small Research ProgramsFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessQA/QI and Postapproval Monitoring
  • Monday, Dec 4th
    1:00 PM – 2:00 PM ET
    A14 - [IN-PERSON/RECORDED] Driving Postapproval Monitoring (PAM) Program Priorities by Harnessing Existing Data
    Location: Room 143 AB
    Speaker: Asmita Kumar, PhD (she/her/hers) – Memorial Sloan Kettering Cancer Center
    Speaker: Maureen Corby, MS, LATg, CPIA (she/her/hers) – Memorial Sloan Kettering Cancer Center
    Speaker: Isabela D. Freedman, PhD, CPIA (she/her/hers) – Rutgers University
    QA/QI and Postapproval MonitoringACU Program ManagementFlexibility and Innovation in Research Oversight Processes
  • Monday, Dec 4th
    2:15 PM – 3:15 PM ET
    B10 - [IN-PERSON ONLY] Protocol Deviations, Protocol Violations, Protocol Variances, Protocol Exceptions, and Noncompliance: What Really Needs to be Reported to an IRB
    Location: Room 150 AB
    Speaker: Leslie M. Howes, MPH, CIP (she/her/hers) – Harvard T.H. Chan School of Public Health
    Speaker: Crystal Kelly, MPH (she/her/hers) – Office for Human Research Protections (OHRP)
    QA/QI and Postapproval Monitoring
  • Monday, Dec 4th
    2:15 PM – 3:15 PM ET
    B03 - [IN-PERSON/RECORDED] Progress in Defining and Evaluating HRPP/IRB Quality and Effectiveness
    Location: Ballroom C
    Speaker: Holly Fernandez Lynch, JD, MBe – Perelman School of Medicine, University of Pennsylvania
    Speaker: Emily E. Anderson, PhD, MPH (she/her/hers) – Neiswanger Institute for Bioethics, Loyola University Chicago
    Speaker: Holly A. Taylor, PhD, MPH (she/her/hers) – National Institutes of Health
    Speaker: Ann Johnson, PhD, MPH – University of Utah
    HRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight ProcessesQA/QI and Postapproval Monitoring
  • Tuesday, Dec 5th
    4:00 PM – 5:00 PM ET
    E17 - [IN-PERSON ONLY] Postapproval Monitoring (PAM) in the Context of Small Research Programs
    Location: Room 209 BC
    Speaker: Kelsey Sharkey Miller, MPH, CPIA (she/her/hers) – Lawrence Berkeley National Laboratory
    Speaker: Shannon Ramsey, CPIA, RLAT (she/her/hers) – Allen Institute
    Resource Person: Jacquelyn Tubbs, DVM, DACLAM – NIH OLAW
    Small Research ProgramsQA/QI and Postapproval Monitoring
  • Wednesday, Dec 6th
    10:15 AM – 11:15 AM ET
    F12 - [IN-PERSON ONLY] Maintaining Compliance at Any Size: How to Get the Most Bang for Your Buck!
    Location: Room 201
    Speaker: Alyssa AK Speier, MS, CIP – Harvard T.H. Chan School of Public Health
    Speaker: Neala J. Lane, MS, CCRC (she/her/hers) – Indiana University
    QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight Processes
  • Wednesday, Dec 6th
    10:15 AM – 11:15 AM ET
    F03 - [IN-PERSON/RECORDED] Utilizing a System of IRB Precedent: Moving Toward Consistency and Transparency
    Location: Ballroom AB
    Speaker: Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center
    Speaker: Ryan Spellecy, PhD – Medical College of Wisconsin
    Speaker: Jackson Norton, CIP – Dana-Farber Cancer Institute
    Speaker: Sarah H. Kiskaddon, JD, MA (she/her/hers) – Dana-Farber Cancer Institute
    Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessQA/QI and Postapproval Monitoring
  • Wednesday, Dec 6th
    10:15 AM – 11:15 AM ET
    F05 - [IN-PERSON/RECORDED] IRB Review of FDA‐regulated Research: From Comfort to Competence!
    Location: Ballroom C
    Speaker: Michelle K. Daiss, CIP (she/her/hers) – Mayo Clinic
    Speaker: Sarah Mumford, MBA, CIP (she/her/hers) – University of Illinois Urbana-Champaign
    QA/QI and Postapproval MonitoringFDA Regulated ResearchHRPP/IRB Administration/Management and Process
  • Wednesday, Dec 6th
    11:30 AM – 12:30 PM ET
    G03 - [IN-PERSON/RECORDED] Improving IRB Quality: Learning from Participants, Investigators, and Outside Experts
    Location: Ballroom AB
    Speaker: Holly Fernandez Lynch, JD, MBe – Perelman School of Medicine, University of Pennsylvania
    Speaker: Holly A. Taylor, PhD, MPH (she/her/hers) – National Institutes of Health
    Speaker: Kimberley Serpico, EdD, CIP – Harvard T.H. Chan School of Public Health
    QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
  • Wednesday, Dec 6th
    11:30 AM – 12:30 PM ET
    G04 - [IN-PERSON/RECORDED] QA/QI for Non‐Clinical or Minimal Risk Research
    Location: Room 147 AB
    Speaker: Pam Stafford, MA (she/her/hers) – Office of Research Integrity, University of Kentucky
    Speaker: Sana Shakour, PhD (she/her/hers) – University of Michigan
    QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessSmall Research Programs
  • Wednesday, Dec 6th
    11:30 AM – 12:30 PM ET
    G17 - [IN-PERSON/RECORDED] Harnessing Data to Drive IRB and IACUC Process Improvement
    Location: Room 144 AB
    Speaker: Keren R. Dunn, CIP (she/her/hers) – Cedars Sinai Medical Center
    Speaker: William A. Hill, DVM, MPH, DACLAM, CPIA (he/him/his) – Florida State University
    Speaker: John D. Horigan, MA, CIP (he/him/his) – National Institutes of Health
    IACUC Protocol ReviewQA/QI and Postapproval MonitoringShared Research Oversight ChallengesHRPP/IRB Administration/Management and ProcessIACUC Administration/Management and Process
  • Wednesday, Dec 6th
    1:45 PM – 2:45 PM ET
    H01 - [IN-PERSON/RECORDED] Insights into IRB Student‐Led Protocol Submissions
    Location: Room 146 ABC
    Speaker: Leslie Wong – Teachers College, Columbia University
    Speaker: Michele Kuchera, MBA, CIP (she/her/hers) – Fordham University
    Speaker: Karen Froud, PhD, CIP (she/her/hers) – Teachers College Columbia University
    Education, Qualifications, and TrainingSBERHRPP/IRB Administration/Management and ProcessQA/QI and Postapproval Monitoring
  • Wednesday, Dec 6th
    1:45 PM – 2:45 PM ET
    H05 - [IN-PERSON/RECORDED] Postapproval Monitoring (PAM) for Studies Overseen by a Single External IRB of Record: Challenges forLocal Monitoring Programs
    Location: Ballroom C
    Speaker: Frederick W. Luthardt, Jr., D.Be., MA (he/him/his) – Johns Hopkins University School of Medicine
    Speaker: Jessica Rowe, MA, MS, CCRP, CIP (she/her/hers) – Yale Cancer Center, Clinical Trials Office
    QA/QI and Postapproval MonitoringSingle IRB