Resource Explorer

Welcome to the UVA Clinical Research Education Series archive!

Recorded sessions from the UVA SOM Clinical Trials Office Clinical Research Education Series are listed below. Enjoy exploring these wonderful resources!

2025

FEBRUARY

Topic: REDCap Database Design Best Practices

Date: 02/07/2025

Speaker: Sarah Ratcliffe, PhD

Objectives:

• Identify the REDCap permissions needed for various user roles on projects
• Understand best practices for creating forms and variables in line wiht common data element standards
• Identify and implement repeated instruments and events

SLIDES

JANUARY

Topic: Environmental Health & Safety Resources and Safe Practices

Date: 01/31/2025

Speaker: Jennifer Kershner, MBA, MT, RBP, CBSP

Objectives:

• Provide an overview of EHS resources with focus on Biosafety
• Review safe practices and procedures when handling biological materials, such as blood or body fluids
• Review appropriate handling of biological waste and sharps

SLIDES

Topic: NCI Cooperative Group Trials

Date: 01/28/2025

Speaker: Maria Davenport, MPH, CCRC

Objectives:

• Evolution/Background of NCI Cooperative Groups
• Operations
• Adverse Events
• Data Quirks
• Audits

SLIDES

Topic: Epic Research Billing Review

Date: 01/23/202

Speaker: Jessica Morris, RDA

Objectives:

• Billing Coverage Analysis
• Grant Pricing
• Epic Research Billing Review

SLIDES

Topic: Understand the Fundamentals: Research Billing Compliance & Billing Coverage Analysis

Date: 01/21/2025

Speaker: Courtney Nightengale

Objectives:

• Clinical Trials Policy (CTP) and its limitations
• Understand the importance of a Billing Coverage Analysis (BCA)
• Internal process for developing, and modifying a BCA
• UVA injury language
• Consequences of improper billing

SLIDES

2024

December

Topic: Leveraging EPIC COSMOS for Researach

Date: 12/06/24

Speaker: Li Mo & Andrea Zhou

Objectives:

• Research real-world data

  • Explore de-identified clinical data in Cosmos

• Use Cosmos tools

  • Leverage tools like SlicerDicer and Data Science Virtual Machine (DSVM)

• Achieve goals

• Work independently or with RCTA team support

SLIDES

Topic: What is Advarra eSource + EDC?

Date: 12/03/24

Speaker: Harrison Miller BS, MDA

Objectives:

• What is Advarra EDC
• How Advarra eSource + EDC streamline studies
• How to get started

SLIDES

November

Topic: HIRE Committee: Exposed

Date: 11/19/24

Speaker: Brigitte Kelly, MSHS, BSM, RN, CCRC

Objectives:

• Describe the purpose of the HIRE committee
• Identify medical imaging within a protocol and when submission to HIRE is required
• Explain what information is needed in your submission to the HIRE committee

SLIDES

Topic: Human Subject Research Protections Program-HRPP

Date: 11/01/2024

Speaker: Andrea Ruhsam

Objectives:

• Understand the Purpose and Role of the Human Research Protection Program (HRPP)
• Implement Best Practices in Human Research Protection
• Prepare for AAHRPP Accreditation Renewal Requirements

Slides

October

Topic: EMERSE: Electronic Medical Record Search Engine

Date: 10/29/2024

Speaker: Fauzia Khan

Objectives:

• How to use EMERSE
• Common uses of EMERSE
• How to submit a request for EMERSE Services & Cost
• Types of requests we most commonly see
• Data we have access to
• How to submit a Research Data Extract & Cost

Slides

Topic: Introduction to Radiation Oncology

Date: 10/25/2024

Speaker: Kara Romano, MD

Objectives:

• Explain how radiation therapy (RT) is incorporated into multidisciplinary cancer care
• Describe basic principles of radiation oncology, applicable to any fieldof medicine
• State commonindications of radiation therapy in the curative and palliative treatment of patients with cancer
• Identify different modalities of radiation delivery including photon, electron, proton and brachytherapy
• Discuss acute and long-term side effects of radiation
• Describe how common diagnostic studiesincluding basic labs, pathology reports, and standard imaging modalitiesare applied to care of patients with cancer•Incorporate ethical, social and diversity perspectives to provide culturally sensitive health careto all patients

Slides

Topic: e-CRF w/REDCap electronic-Case Report Form

Date: 10/22/2024

Speaker: Fauzia Khan

Objectives:

• What is REDCap?
• How to build your CRFs in REDCap
• How to submit a REDCap Build request and cost

Slides

May

Topic: Overview on Treatment for PTCL and Specific Research Challenges

Date: 05/21/2024

Speaker: Enrica Marchi, MD, PhD

Objectives:

• Understanding the complexity of PTCL

• Treatment options in first and second line

• Brief overview of specific clinical and therapeutic issues of patients with PTCL

April

Topic: What Did They Do to Us!? (Part 2): Identifying and learning common drug to drug interactions in a clinical setting and how to utilize high quality resources

Date: 04/19/2024

Speaker: Chloé LeBegue-Polley, Pharm D

Objectives:

• Learn how to utilize high quality drug-drug interaction resources

• Identify common drug-drug interactions in an oncology setting

• Patient case

Slides

Topic: What Did They Do to Us!? (Part 1): Understanding pharmacokinetics, pharmacodynamics and common pathways for drug-drug interactions

Date: 04/18/2024

Speaker: Chloé LeBegue-Polley, Pharm D

Objectives:

• Differentiate between pharmacokinetics and pharmacodynamics
• Understand common pathways for drug-drug interactions

Slides

March

Topic: Florence E Binder and UVA Research

Date: 03/12/2024

Speaker: John Flemmons and Virginia Kelly

Objectives:

• What is Florence eBinders?
• Florence eBinders Workflow
• Florence eBinders Access Timeline
• Florence eBinders Training and Support

Slides

February

Topic: Billing Coverage Analysis / Epic Research Billing Review

Date: 02/27/2024

Speaker: Jessica Morris, RDH & Courtney Nightengale

University of Virginia; School of Medicine-Clinical Trials Unit

Learning Objectives:

• Associating Patients to Research Study
• Linking Encounters & Orders to Research Study
• Performing Billing Review in Epic

Slides

Topic: 2024 IRB-HSR Updates

Date: 02/20/2024

Speaker: Heather Ferreri, MPH, CIP

University of Virginia; Director, Institutional Review Board for Health Sciences Research (IRB-HSR)

Objectives:

• Discuss new IRB-HSR staffing and contact information
• Learn tips for efficient protocol approvals
• Review updates and future plans for IRB-HSR

Slides

January

Topic: ClinicalTrials.gov Overview and Tips for Success

Date: 01/25/2024

Speaker: Jodi Darring

Objectives:

• Promote an understanding of the specific roles and responsibilities of researchers and the study team (UVA specific)
• Participants will gain practical tips for efficient navigation, search and utilization of ClinicalTrials.gov (and the PRS system).

Slides

Topic: Clear, Clinical, Compassionate Communication

Date: 01/11/2024

Speaker: Kelly Reed, RN, CCRN-K, PhD Student

Objectives:

• Explain common clinical terms and concepts

• Provide recommendations for clear, professional documentation in the healthcare setting

• Provide helpful tips and tricks on therapeutic and compassionate communication

Slides

2023

October

Topic: OnCore Updates October 2023

Date: 10/16/2023

Speakers: Charles McMillian, Jenny Embrey, John Flemmons, Jennifer Greene

Objectives:

· Describe the functionality of Departmental Annual Reports (DARS)

· Discuss the internal review process to review accrual numbers.

· Understand the responsibility of each study team as it pertains to OnCore entry.

· Describe the process of adding expedited studies to OnCore

Slides

September

Topic: Investigational Drug Services

Date: 09/08/2023

Speaker: Amy Adams PharmD

Learning Objectives:

• Understand who your IDS team is and how to contact them
• Learn procedures for protocol set up in IDS
• Understand how IDS complies with regulations for your studies
• Know your options for utilization of IDS Services

Slides

August

Topic: Records Management for Clinical Research

Date: 08/11/2023

Speaker: Caroline J. Walters, CRM

University Records Officer, Records & Information Management, University of Virginia

Learning Objectives

• Understand the legal requirements and retention rules for clinical trial records at UVA.
• Recognize the challenges and develop solutions for managing clinical trial records in both electronic and physical formats.
• Learn about the services of the UVA Records & Information Management Office in connection with the management of clinical trial records.

Slides

Topic: Statistical Perspective of Study Data Management

Date: 08/07/2023

Speaker: Sarah Ratcliffe, PhD, Professor & Director of Biostatistics

Senior Vice Chair for Research, Department of Public Health Sciences

Director, iTHRIV Research Methods Core, University of Virginia

Learning Objectives

• Describe the stages of data management in clinical studies
• Identify common data management issues
• Describe the process for data cleaning and analysis

Slides

July

Topic: Florence e-Binder

Date: 07/28/2023

Speaker: Amy Warren, MS, CCRC

Learning Objectives

• Explore the Florence website
• Review available training resources for Florence eBinder
• Review the implementation timeline for General Research

Slides

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Topic: Docusign

Date: 07/24/2023

Speaker: Rachel Sligar, Document Imaging and DocuSign, Information Technology Services, UVA

Learning Objectives

• Describe how to gain access to DocuSign and important information about the Clinical Research and Part 11 account at UVA.
• https://med.virginia.edu/clinicalresearch/research-resources/offices-supporting-clinical-research/clinical-trials-office/docusign/.
• Demonstrate logging into DocuSign.
• DocuSign Demo! Demonstrate creating a template, setting up recipients and adding fields to the form, and sending to the recipient.

Slides

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Topic: Decentralized Clinical Trials (DCT)

Date: 07/17/2023 (All Institutions)

Speaker: Francis Farrell, PhD; Senior Director, Research and Development, Carilion Clinic Learning Objectives

• Define what is meant by a decentralized clinical trial (DCT)
• Have a general understanding of the current regulatory landscape for DCTs
• How a DCT methodology was used to conduct a COVID-19 public health seroprevalence study

Slides

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January

Topic: COVID‐19, Immune Response, and Neurologic Complications

Date: 01/27/2023 (All Institutions)

Speaker: William A. Petri, Jr., MD, Ph.D (University of Virginia)

Objectives:

• Where are we?
• How did we get there?
• A personal response
• Anosmia as a neurologic complication

Slides

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Topic: Pre-award Management For Clinical Research (Part III)

Date: 01/20/2023 (UVA Specific)

Speaker: Lauren Armstrong, CRA, University of Virginia

Objectives:

• Understand documents required to execute successful Clinical Trial Agreements
• Review and utilize SOM clinical trial budget template
• Understand common Clinical Trial Agreement language and identify generally problematic terms and conditions

Slides

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01/19/2023 - EPIC Research Overview & Using Electronic Source for Subject Data

Speaker(s): Trish Northington, BSN, RN & Maria Davenport, MPH, CCRC; University of Virginia

• Research Reporting Home Dashboard
• Associating Patient to Research Study (including Research Activity Tab Overview, Finding Study, Enrollment type definitions)
• Research Study Encounter Association
• Pending Orders and Research Order Association
• Billing Report/Reconciliation : Demo
• Tips for creating electronic binders
• Utilizing Checklists and Smart Phrases in EPIC
• Using EPIC to Manage Collection of Inclusion/Exclusion, AE/SAE Reporting, Medical History, and Protocol Deviation Logs

Slides

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2022

December

Topic: Pre-Award Management for Clinical Research (Part II)

Date: 12/12 -(UVA Specific)

Speaker: Lauren Armstrong, CRA, University of Virginia

Learning Objectives:

• Understand how to create and complete the companion Agreement and Funding Proposal requests for a Clinical Trial in rPBH

• Understand how to complete the budget module for Clinical Trials in rPBH

• Understand how to obtain approvals and route Clinical Trial Agreements and Funding Proposals in rPBH

Slides

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Topic: UVA-HSR IRB Year End Update 2022 & Research Match

Date: 12/8 - (UVA Specific)

Speakers: Eileen Sembrowich, Interim Director UVA IRB-HSR and Gloribel Bonilla, UVA ResearchMatch Liaison (Oncology)

Learning Objectives:

• Demonstrate how to add or delete personnel within IRB Pro.
• Determine the which GCP requirement (FDA or ICH focus) is required for your research studies.
• Demonstrate how submit study documents to the IRB-HSR via IRB-Pro
• Examine submission process for recruitment materials to the IRB-HSR.
• Describe the definition of electronic informed consent, process of e-consent, and platforms used at UVA.
• Describe ResearchMatch and how it may be used for research participant recruitment.

Slides
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Topic: Pre-Award Management for Clinical Research (Part I)

Date: 12/5 - (UVA Specific)

Speaker: Lauren Armstrong, CRA, University of Virginia

Learning Objectives:

• Understand how to create and complete requests for standard non-funded Agreement types in _Research_UVA Powered By Huron (rPBH)
• Understand how to obtain approvals and route Agreement requests in rPBH
• Demonstrate how to track and monitor the progress of an in-process Agreement record in rPBH

Slides

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Topic: Introduction to Lean

Date: 12/2 - (All institutions)

Speaker: Wendy Novicoff, Ph.D., University of Virginia

Learning Objectives:

• Review and describe how LEAN was developed.
• Describe LEAN terminology and methodology.
• Describe the steps in developing a LEAN project and review examples.

Slides