Clinical Research Seminar
The purpose of the monthly Clinical Research Seminar (CRS) is to enhance attendees’ knowledge regarding important ethical, regulatory, and operational clinical/human research topics. Clinical Research Seminars are organized by the CRRO, with support from the BU Clinical Translational Science Institute (CTSI) and the Office of Human Research Affairs (OHRA).
Seminars take place from 12 pm to 1 pm, typically on the second Wednesday of the month. If the seminar takes place in-person, we supply a nice lunch to enjoy. But for the foreseeable future, we are holding the seminars on Zoom (but you can still enjoy your lunch while you learn!).
Please register by following the blue title link for each seminar that you would like to attend. (And keep checking back as the calendar is updated). For the security of the session, pre-registration is required. Please note that you must use your institutional/work email to register. If you need an exception to this requirement, please contact Mary-Tara Roth at firstname.lastname@example.org.
For slides and video for seminars that have already happened, scroll down to “Past Seminars” link below.
Clinical Research Seminar Dates — September 2021 – June 2022
(Scroll down for registration links)
Slides and videos from past seminars available here: Past Seminars
September 22 (Wed), 2021, 12:00-1:00 p.m.
Title: IRB Submission Overview for Chart Reviews & Secondary Analyses
Presenters: Carolyn Swain, MPH, IRB Analyst and Emily Crowley, MPH, IRB Administrator
- Understand which regulatory determinations likely apply to your study
- Choose the correct review pathway
- Use correct terminology to support your review pathway
- Know what responses the IRB is looking for on application questions
October 13 (Wed), 2021, 12:00-1:00 p.m.
Title: A Surfeit of Surveys: Exempt Category 2
Presenters: Daly Franco, Senior IRB Analyst and Lin Themelis, IRB Administrator
- Identify if the research is Exempt 2 Research
- Tell what is identifiable vs. anonymous exempt 2 Research
- Learn what the IRB needs to make an Exempt 2 determination
- Learn practical tips on how to prepare INSPIR application for Exempt 2 Research.
November 17 (Wed), 2021, 12:00-1:00 p.m.
Title: Case Report Form Design
Presenter: Kimberly Ann Dukes, PhD, Executive Director, Biostatistics and Epidemiology Data Analytics Center, BU SPH
- The necessity of incorporating data sharing requirements
- Key design elements and inclusion of standard measures
- Importance of pilot testing, change management and optimization of data architecture
December 15 (Wed), 2021, 12:00-1:00 p.m.
Title: Update on Informatics resources and services for the BMC/BUMC community
Presenter: Bill Adams, MD, Professor, BU School of Medicine
- Discuss Tools and Resources, including:
- BMC Clinical Data Warehouse (CDW)
- i2b2, SHRINE, ACT Network
- Consultation Service
- Discuss Data for Equity (D4E) Project
January 12 (Wed), 2022, 12:00-1:00 p.m.
Title: Clinical Research Operations at Boston Medical Center: A guide to how the Clinical Trial Office can support successful, inclusive research practices
Presenter: Johanna C. Chesley, MPH, Senior Director, Clinical Trial Office
- Review CTO’s role and responsibilities within the department of Research Operations
- Assess CTO’s newest customer service offerings
- Discuss study team clinical research workflow
- Learn about CTO’s FY22 goals and initiatives
- Open discussion
February 9 (Wed), 2022, 12:00-1:00 p.m.
Title: Conducting Research with Boston Healthnet Community Health Centers
– Allyson Richmond, Program Manager, Boston HealthNet at Boston Medical Center (BMC)
– Matthew Ogrodnik, MS, CIP, Director, Office of Human Research Affairs (OHRA)
- Learn about Boston Healthnet (BHN)
- Understand the new process for conducting research with BHN CHC’s
- Review how to navigate the IRB submission process for CHC research
March 16 (Wed), 2022, 12:00-1:00 p.m.
Title: Applying Health Literacy to Clinical Research Communications
Presenter: Sylvia Baedorf Kassis, MPH, Program Manager, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
- Describe what health literacy is and its relevance to clinical research.
- Explain how health literacy best principles can be integrated into different phases of the clinical research life cycle.
- Identify at least one health literacy best practice to integrate into a participant-facing communication.
April 12 (Tues), 2022, 12:00-1:00 p.m.
Title: To IRB or Not to IRB: That is the Question
– Nicholas Cordella, MD, MSc, Medical Director of Quality and Patient Safety, Boston Medical Center
– Emily Jansen, MPH, Senior Program Manager, Quality and Performance Improvement for the QI Hub and Barry M. Manuel Continuing Medical Education Office
– Brandon Finn, BA, IRB Analyst, Boston Medical Center/Boston University Medical Campus IRB
– Jasmine Huerta, MD, MS, MPA, Internist, QI Fellow, Boston Medical Center
- Differentiate the underlying intent of research and quality improvement projects
- Critically appraise whether a project should or should not be submitted to the IRB
May 11 (Wed), 2022, 12:00-1:00 p.m.
Title: The BMC Clinical Data Warehouse (CDW) for Research: Get Research-Ready Data for Your Studies
Presenter: Erin Ashe, MPH, Program Director, CDW for Research
- Describe the BMC CDW for Research, including data available in the data warehouse, services offered by the CDW for Research, how to engage with the CDW for Research, and answers to other FAQs
- Share updates on the CDW for Research’s current initiatives and strategic goals
- Discuss information and approvals required to effectively request data from the CDW for Research
June 8 (Wed), 2022, 12:00-1:00 p.m.
Title: Using Clinical Data Warehouse for Research: Real-World Case Studies in Data Literacy
Melissa Hofman, MSIS, Research Informatics Director, CDW for Research
Heather Hsu, Scientific Director, CDW for Research
- Describe key concepts in data literacy and the data lifecycle that are important to understand when using clinical data in research.
- Discuss real-world case studies that demonstrate the DOs and the DON’Ts of using data captured within electronic medical records for research analyses.
- Discuss exemplar health informatics projects and research case studies that meaningfully leveraged available data by applying key concepts.
Attend this session to learn how to operationalize research projects that use clinical data. The session will help you build a fundamental understanding of data and data structures to increase data-literate decisions. We will discuss practical, real-world cases to illustrate how (and how not) to leverage clinical data for research. Cases will highlight the importance of understanding how the full data lifecycle influences data capture, extraction, and analysis – allowing you to increase your ability to optimally leverage data in future research.
This session is Part 2 of a two-part series from the BMC CDW for Research. If you are interested in learning more about the CDW for Research (including data available in the data warehouse, services offered by the CDW for Research, and how to request data), we encourage you to visit our website<https://www.bmc.org/research/clinical-data-warehouse-cdw> and watch Part 1 of this series<https://www.bumc.bu.edu/crro/training-education/past-seminars/>.
Keep checking back for additions to the calendar!
For video and slides of past seminars see the link below.
For additional information or questions, contact Mary-Tara Roth (email@example.com).