Clinical Research Network Seminar Series

The Clinical Research Network (CRN) meets monthly beginning at 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 May 1, 2019

Previous CRN Seminars

Jan 11

September 27

July 26

June 26

April 26

February 22

January 25

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

March 31

  • Sponsor Audits

February 25

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

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

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

February 27

January 23

October 24

September 26

June 27

FDA links provided by speaker:

May 23

April 25

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

February 28

January 24

October 25

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:

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”

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

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

February 25

January 28

  • “Boosting Enrollment through Regional Online Outreach”