Clinical Research Coordinator Seminar Series

May 1

• Research misconduct awareness for clinical research conducted at Georgetown University
• Mary Schmiedel, Senior Director, Office of Research Oversight, GU; Jake Stein, Clinical Research Operations Office, GUMC
• Conflict of interest process related to the new IRB system
• Development of new study feasibility tool
• Shaunagh Browning Director, Office of Research Quality Assurance, GUMC; Alyssa Stucke, Senior Clinical Research Coordinator, MedStar Georgetown Transplant Institute

April 3

• Presentation from ECG Management Consultants
• Share your insight by joining your other clinical research administration for a one time engagement with ECG Management Consultants. Their time on campus with you is part of a larger project that explores the opportunities for GU and MedStar Health to form a larger, more synchronized research operation. Your voice and experiences are crucial to this design phase.

Jan 11

• New process for radiology support requests.  Document links below.
  (The process may evolve some so there can be a tie-in with GU PASS and different notifications set up.)
• Radiology Support for Clinical Trials
• Radiology Services Research Support Request Form
• Radiology Tip Sheet
• Radiology PPT
• Anyone with questions about the new IRB system is encouraged to reach out to the IRB office at anytime.
  You can also access the IRB website with multiple guidance documents: https://ora.georgetown.edu/georgetownmedstarirbsystem
• At next month’s CRC, we’d like to talk a bit about handling new calendar versions in OnCore.  I’m including a Tip Sheet here that shows the basic process of moving subjects to a new calendar version.

September 27

• Slides for New Radiology Service Request Process
• Slides for PowerTrials and OnCore
• Slides for Box Overview Training

July 26

• Forte Webinar on Best Practices for Ethical and Compliant Delegation of Authority at Your Research Institution
• Slides of the webinar are also available

June 26

• Slides for Importance of NCT numbers (registration from clinicaltrials.gov) in compliant billing (registered study vs. Applicable Clinical Trial/qualifying clinical trial)
• Slides for entering SAEs in OnCore for sponsor billing

April 26

• Slides for HIPAA Requirements for Clinical Research
• Kelly Blevins, University Counsel, Office of General Counsel, GU; Sheila Zimmet, Senior Associate Vice President for Regulatory Affairs, GUMC
• Slides for Information Security Best Practices
• Gayle Jones, UIS, GU; Jessica Pierce, UIS, GU

February 22

• Slides for Lifecycle of a Clinical Trial Pt 2: General Study Startup and Funding Sources
• Irene Jillson, PhD, Associate Professor, School of Nursing and Health Studies, Georgetown University

January 25

• Slides for Lifecycle of a Clinical Trial Pt 1: Drug Discovery, Drug Development, and Trial Phases
• Pravin Chaturvedi, PhD, IndUS Pharmaceuticals, Inc.
• Slides for Workflow with OnCore CTMS and GU PASS

December 12

• Overview of Georgetown Study Start Up Workflow

November 17

• Slides for Changes to the Common Rule (the Federal Policy for the Protection of Human Subjects) 

October 26

• Slides for Data Management; Slides for Record Retention; Slides for FDA Warning Letters
• Slides for GR End Dates in GMS and Submitting CRC Allocations

September 28

• Slides for GCP Revisions and Training Options

June 22

• Slides for Updates on OnCore CTMS, Information for Budgets and Contracts

April 27

• Slides for How to Leverage GHUCCTS Recruitment Core Services

July 20

• Nimblify Participant Payment System Demo, CTMS Update and Demo, Update on Budget Policies
  • Jill Heathcote, Customer Account Manager, Nimblify; Allison Keuthen, MedStar Health Research Institute; Alyssa Parks, Clinical Trials Coverage Analyst, Clinical Trials Operations, GUMC
  • Please email Bronwyn Murray (bm296@georgetown.edu) if you would like the slides for Nimblify or CTMS

June 23

• Recruitment Strategies for Research Subjects
  • Karen Teber, Sr. Director, Strategic Communications, GUMC and Emily Paku, Program Coordinator, MedStar Health Research Institute
  • Please email Bronwyn Murray (bm296@georgetown.edu) if you would like the slides for ResearchMatch

May 26

• Clinical research progress notes and consent process documentation

April 28

• Vulnerable Populations and Fluctuating Capacity
  • Priscilla Adler, MBA, CCRP, Director, Regulatory Affairs, MedStar Health Research Institute
  • Listen to and view the presentation

March 31

• Sponsor Audits

February 25

• IRB Submissions and eRIC
  • Kristen Katopol, Director Human Subjects Protection Program and Cat Borgiasz, IRB Program Coordinator
  • Listen to and view the presentation

October 22

• Revenue Recognition for Sponsored Clinical Trials
  • Speaker: Jenny Turnure, Director of Finance and Administration, BGRO, GUMC

September 24

• Webinar: Notice of Proposed Rulemaking (NPRM) for Changes to the Federal Policy for the Protection of Human Subjects
  • Please contact Bronwyn Murray (bm296@georgetown.edu) if you would like the slides from the PRIM&R webinar or information about other webinars on the NPRM that are freely available.

June 25

• Responsible Conduct of Research
  • Speaker: Sheila Cohen Zimmet, BSN, JD, Senior Associate Vice President for Regulatory Affairs, Georgetown University
  • Listen to and view the presentation
• ResearchMatch
  • Speaker: Sinéad Gilmore, BS, Outreach Program Coordinator, ResearchMatch Liaison, Georgetown Clinical Research Unit
  • Listen to and view the presentation

May 28

• Closing the Gender Gap in Medical Research
  • Speaker: Kathryn Sandberg, PhD, Director, Center for the Study of Sex Differences in Health, Aging and Disease, GUMC
  • Listen to and view the presentation

April 23

• Medicare Coverage Analysis for clinical trials
  • Speaker: Mary Anne Hinkson, MBA, Vice President, Research Operations, MHRI
• Important changes to some key clinical trial procedures
  • Speaker: Tony Hursey, MPH, Director, Clinical Trials Office, GUMC
• Listen to and view the presentation

March 26

• Clinicaltrials.gov
  • Speaker: Rebecca J. Williams, Pharm.D., MPH, Assistant Director, ClinicalTrials.gov, National Library of Medicine, National Institutes of Health
  • Listen to and view the presentation
• GreenPhire Clin Card
  • Speaker: Diane Scott, MBA, CRA, Senior Business Manager, Georgetown University Medical Center Finance Office
  • Listen to and view the presentation

January 22

• Conducting Research in the Community: how to identify needs and what we all gain
  • Speaker: Daniel Merenstein, M.D., Associate Professor, Director of Research Programs, Department of Family Medicine, GUMC

October 23

• Principal Investigator Responsibilities
  • Speaker: Jean Mulinde, M.D., Acting Senior Advisor, Division of Good Clinical Practice Compliance, Office of Scientific Investigations, Office of Compliance, CDER, FDA
  • Listen to and view the presentation

September 25

• Bench to Bedside at Georgetown: Preclinical Science to Clinical Trials with Nilotinib
  • Speaker: Charbel Moussa MBBS, PhD, Assistant Professor, Laboratory for Dementia and Parkinsonism, Department of Neuroscience, GUMC
• Introduction to Kristen Katopol, the new Director of the Human Subject Protection Program at Georgetown University
• Listen to and view the presentation

August 15

• Performing key clinical trial related financial tasks in GMS
  • Speaker: Jennifer Turnure, Director of Finance and Administration, Clinical and Centers, BGRO
  • Listen to and view the presentation

June 26

• Investigator Initiated INDs: the submission process and ongoing reporting obligations
  • Speakers: Sharon Levy, Administrative Director-Clinical Research Management Office, MedStar Georgetown Cancer Network, Georgetown Lombardi; Tina Tan, Research Associate, Department of Family Medicine, GUMC
  • IND Submission Process and Reporting Obligations; Maintaining an IND
  • Listen to and view the presentation

May 22

• The SUPPORT Study: A panel discussion of the controversy surrounding a comparative effectiveness study in premature infants
  • Speakers: Sheila Zimmet, BSN, JD, Senior Associate Vice President for Regulatory Affairs; Siva Subramanian, MD, Chief, Division of Neonatology; Kevin Donovan, MD, MA, Director, Pellegrino Center for Clinical Bioethics

April 24

• TRACS, PACTS, and STARS (Transmittal Review and Compliance System, Clinical Trials Pre-Award Contract Tracking System, and Subaward Tracking and Review System)
  • Speaker: Doreen Robinson, PhD, CRA, Senior Associate Vice President for Sponsored Research/Director, Office of Sponsored Research, GUMC
• Introduction to the GHUCCTS community engagement component
  • Speaker: Florencia Gonzalez, MPH
  • Community-Engaged Research Principles; Community Engagement Services

March 27

• Data and Safety Monitoring
  • Speakers: Donna Jones, Program Analyst, Office of Clinical Research, NHLBI/NIH; Katharine Cooper-Arnold, MPH, Clinical Research Coordinator, Office of Clinical Research, NHLBI/NIH
• Listen to and view presentation

February 27

• Working with the Research Pharmacy
  • Speaker: Khang Ho, PharmD, Research Pharmacy Manager

January 23

• The IRB Review Process: Q&A Session with Board Members
  • Speakers: Mary Young, MD; Khang Ho, PharmD; Kim Groner, RN, MSN
  • Main presentation; Presentation on continuing review

October 24

• Tips from a Clinical Trial Monitor
• Listen to and view presentation

September 26

• Setting Up and Using a Research Subject Registry – the Georgetown Research Volunteer Program (GRVP)
  • Speaker: Rachel Barr, PhD, Associate Professor, Department of Psychology, Georgetown University
• Clinical Research Unit (CRU) update: Online Appointment Request Training
• Speaker: Haewon Park, MPH, CRA, Administrative Director, Clinical Research Unit

June 27

• Avoiding Common Mistakes in Clinical Research
  • Speaker: Bhanu Kannan

FDA links provided by speaker:

• Running Clinical Trials
• Selected FDA GCP/Clinical Trial Guidance Documents
• Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical   Investigators, and Sponsors
• Information Sheet Guidance: Frequently Asked Questions – Statement of Investigator (Form FDA 1572)

May 23

• Returning Results in Genomic Research Studies: Emerging Issues
  • Speaker: Shawneequa Callier, JD, MA
• Listen to and view presentation   

April 25

• Q&A Session on Clinical Trial Start-Up/Processes

February 28

• TRACS vs. PACTS vs. STARS
  • Speaker: Trudy Bright
• Using sponsor sample consent documents
  • Speakers: MedStar Georgetown Transplant Institute Research Team

January 24

• Tips for writing a good informed consent from the research participant advocates
  • Speakers: Sarah Vittone, MSN, MA, RN and Priscilla N. Adler, MBA, CCRP
• CRU updates
  • Speakers: Haewon Park, MPH, CRA and Shaunagh Browning, RN, FNP-BC

October 25

• Panel on recruitment and retention of research subjects
• Introduction to ResearchMatch.org

September 27

• Seminar to review key GU financial processes and demonstrate PACTS v2, the new web-based system for submission of trial contracts. Speakers: Rachel Kidwiler, Doreen Robinson, and Jennifer Foley.
• Listen to and view presentation (includes PACTS v2 demonstration)

Presented Materials:

• Navigating Financial Policy and Procedure at Georgetown University Medical Center
• Working with the Office of Sponsored Research on Industry-Sponsored Clinical Trial Agreements

September 22

Ira Shoulson, M.D., Director of the Program for Regulatory Science and Medicine (PRSM) at GU.  “The Emergence of Regulatory Science and Medicine”

June 23

Doreen Robinson, Ph.D., Senior Associate VP Office of Sponsored Research (OSR) “Role of the Office of Sponsored Research in Clinical Research Activities“

May 26

Joseph Verbalis, M.D., co-Principal Investigator GHUCCTS “Transforming Clinical Research and Translational Science”

April 28

Jonathan S. Helfgott, Consumer Safety Officer at FDA, Center for Drug Evaluation & Research (CDER), Office of Compliance, Division of Scientific Investigations(DSI) “Computerized Systems in Clinical Trials and Part 11”.

March 24

Leslie Ball, M.D., Director of the Division of Scientific Investigations (DSI), Office of Compliance, CDER, FDA “Investigator Responsibilities – IND Regulations and Clinical Trials”

February 24

Judith Baigis, R.N., PhD, Professor Nursing and Research Subject Advocate (RSA) with Georgetown’s Clinical Research Unit (CRU) will moderate “Ethics and Research in Vulnerable Populations”.

• Research Participant Advocate (RPA) Role
• Vulnerable Minority Populations
• Optimizing the Consent Process in Subjects with MCI and AD

January 27

Joseph Verbalis, M.D., Co-Principal Investigator GHUCCTS “Transforming Clinical Research and Translational Science” (rescheduled due to inclement weather- see May 26, 2011)

January 10

Lili Portilla, MPA, Senior Advisor for Technology Transfer, National Center for Research Resources (NCRR) “Bridging Research and Commercialization: How the NIH Can Help”

October 28

Marian Serge, R.N., Center for Devices and Radiological Health will present “IDE and Approval Process, Emergency and Humanitarian Use“.

September 23

Michele Malloy, Research Support Coordinator, Dahlgren Memorial Library will discuss “Research Support Updates”.

• Deborah Zarin, M.D., Director of ClinicalTrials.gov will present information on ClinicalTrials.gov (a registry of federally and privately supported clinical trials conducted in the United States and around the world).

June 24

• “50 Wrong Ways (and Right Ways) to Collect Data“

May 27

• “Can we enroll our first patient yet? Come learn strategies for quickest approval of your new study by the IRB, OSR, CTO and GCRC.”

April 22

• “When The IRB Shuts Down Your Clinical Study: Making Lemonade from Lemons”

March 25

• “Comparative Effectiveness Research, How is it Different?“

February 25

• “Research Billing Compliance”  “Qualifying Trial Criteria“

January 28

• “Boosting Enrollment through Regional Online Outreach”