Clinical Research Network Seminar Series

 

The Clinical Research Network (CRN) meets on the 4th Thursday of the month beginning @ 12:30 - 2:30 pm in the Warwick Evans Conference Room (Building D). Lunch will be served at the meetings.

Email Bronwyn Murray bm296@georgetown.edu to be added to the CRN mailing list

Upcoming CRN Seminar

The next CRN will be on April 27, 2017

 

Previous CRN Seminars

2016

September 22:

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 Strageties 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:

March 31:

  • Sponsor Audits

February 25:

 

 

2015

October 22:

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:

May 28:

April 23:

March 26:

January 22:

 

 

2014

October 23:

September 25:

August 15:

  • Performing key clinical trial related financial tasks in GMS

June 26:

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
  • Article about the SUPPORT study: U.S. Weighs Informed Consent Rules in Wake of Infant Study Controversy. (August 30, 2013, Arthur Allen, Science Insider).  The U.S. government is considering changing how biomedical researchers inform patients about the risks of some clinical experiments in the wake of an acrimonious debate over a study involving premature infants. 

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

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:

January 23:

 

 

2013

October 24:

  • Tips from a Clinical Trial Monitor

Listen to and view presentation

September 26:

June 27:

Avoiding Common Mistakes in Clinical Research

  • Speaker: Bhanu Kannan

FDA links provided by speaker:

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

2012

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: 

2011

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".

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"

2010

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"