Overview of Fundamentals of Medical Research
2014
Tools of the trade:
successful strategies for research
in medicine
Michele Kutzler, PhD
Assistant Professor of Medicine
Assistant Professor of Microbiology and Immunology
Assistant Dean of Faculty Affairs
Tools of the trade:
successful strategies for research in medicine
Why participate in research?
Satisfaction of answering important questions which will
improve the health of patients
Knowledge, skill and technical advancement
Professional advancement
Collaboration across departments/divisions/schools/globally
Potential external funding that can be obtained
Research publication
Travel to professional conferences to present research
Development of mentor/mentee relationships
Tools of the trade:
successful strategies for research in medicine
Important choices to make:
1. Choose an area of research that matches your interests
1. Choose a type of research that fits your skill set, time constraints and
career goals
basic
translational
patient-oriented (including Quality Improvement Projects)
epidemiological
patient services
Health policy
analysis of secondary data
3. Seek out a research mentor or collaborators that will provide the peer
review, support, expertise and dedication that is necessary for the
project’s success
Research Methodologies in Quality Improvement
FMR 2014: Presented by Dr. David Cooperberg
Dr. Cooperberg joined St. Christopher’s Hospital for Children
as Assistant Professor of Pediatrics at Drexel University
College of Medicine. Dr. Cooperberg has expertise in process
improvement as a Lean Leader at St. Christopher’s Hospital
for Children. He has led or co-led 12 national workshops on
QI and patient safety education, QI curriculum development,
integrating evidence-based medicine and QI, and creating a
culture of patient safety.
http://www.drexel.edu/research/compliance/qa/
The Quality Assurance/Quality Improvement Program (QA/QI) is a unit within the Office of
Research independent of the IRB and all human research related departments.
QA/QI's objective is twofold: To support institutional regulatory compliance and to assist investigators in the human clinical
research process. QA/QI is independent of the IRB. QA/QI supports the Human Research Protection Program. The objectives of
this group in no way conflict with those of IRB and/or other regulatory agencies. The QA/QI functions independently.
The QA/QI aims to promote a culture of compliance with the highest legal and ethical standards for the conduct of human
research. It is also committed to education of the Drexel and affiliates research community and outreach to collaborating
institutions striving for research excellence.
Research Plan from concept to publication
Year 1
Year 2
Research
1st 6 months
Identify research
focus
Identify collaborators
and mentors
Do CITI and lab
safety training
Identify research
resources
that you need to be
successful
2nd 6 months
Read literature
Study design
meet with biostat
IRB app
IRB application
Data capture
Year 3
Publication
CV preparation
Apply for grants
SeptemberJanuary
Colleagues/peer Review
February-April
Write abstract
Apply for conference presentation
April- August
Manuscript preparation
Present at Internal Research Day Opportunities
Tools of the trade:
successful strategies for research in medicine
Training requirements before research
begins!
Required Online Clinical Research Training!!!
Human Subjects Research Training Program
As of July 1, 2010, all Key Research Personnel engaged in humans subject research must complete the
online Collaborative Institutional Training Initiative (CITI) Training Program prior to IRB approval of a new or
continuing review application.
http://www.drexel.edu/research/co
mpliance/humanSubjects/
Conducting Research:
Laboratory Safety Training Requirements
Drexel Core Modules
1. HIPAA and Medical Research (Part I)
2. HIPAA Security (Part II)
3. Infectious Substances Packaging
4. Substituted (Surrogate) Consent
5. Recombinant DNA Molecules Training
6. Select Agent Policies and Procedures
7. Laboratory Safety and Bloodborne Pathogen Training
REMEMBER!!!! OSHA health visit: PPD and approval to work in lab that
conducts animal research –allergies?
http://www.drexel.edu/research/compliance/regulatory/Biosafety/Safety%20Training/
Tools of the trade:
successful strategies for research in medicine
Research study design and biostatistics
Biostatistics and Study Design Concepts
FMR 2014: Presented by Dr. Edward Gracely and Dr. Jay Horrow
Day 1 (Dr. Ed Gracely)
Biostatistics I: Descriptive Statistics and Standard
Errors
Biostatistics II: Hypothesis Testing and Confidence
Intervals
Day 2 (Dr. Ed Gracely)
Biostatistics III: Power and Sample Size
Biostatistics IV: Multivariate Statistics
Day 2 (Dr. Jay Horrow)
Study Design and Research Methodology
General Consulting and Data Analysis support for
faculty at DUCOM
Mission: The Biostatistics Service Center (BSC) provides
professional, high quality data analysis, biostatistical computing,
and data management services to a wide range of clients in
biomedical and public health research, including: observational
studies (epidemiologic or clinical), clinical trials, outcomes
research (including studies involving large prescription and
diagnostic databases), and animal studies.
Our team is comprised of Masters level statisticians and affiliated
faculty members from the Department of Epidemiology and
Biostatistics. Every project we take on is assigned to a senior
statistician with a Masters trainee under the guidance of a
faculty member.
http://publichealth.drexel.edu/academics/departments/epidemiology-biostatistics/biostatistics-service-center/
Tools of the trade:
successful strategies for research in medicine
Getting IRB approval
Navigating IRB submissions at DUCOM
FMR 2014: Presented by Jack Medendorp
http://www.drexel.edu/research/compliance/humanSubjects/irb/
Jack and his team will assist investigators in
the Drexel IRB process. Within the website
you find the necessary forms and
instruction to assist you in applying to the
Drexel IRBs as well as guidance to
conducting human research in a manner
that promotes protection of human
subjects.
Tools of the trade:
successful strategies for research in medicine
Secure website databases for capturing
patient data
REDCap Consortium: DUCOM PARTNER
FMR 2014: Presented by Lauren May and Dr. Vanessa Pirrone
The REDCap Consortium is comprised of 255 active institutional partners
from CTSA, GCRC, RCMI and other institutions, and it supports a secure web
application (REDCap) designed exclusively to support data capture for
research studies.
It is a secure web application for building and managing online surveys and
databases.
The REDCap application allows users to build and manage online surveys and
databases quickly and securely, and is currently in production use or
development build-status for more than 20,340 studies with over 28,930
end-users spanning numerous research focus areas across the consortium.
http://project-redcap.org/
https://www.drexelmed.edu/Home/Research/REDCap.aspx
Tools of the trade:
successful strategies for research in medicine
Data collected and compiled:
Presenting results
Effective Delivery of Oral Presentations
FMR 2014: Presented by Dr. Neilanjan Nandi
How do you prepare an oral
presentation?
What are some of the factors that contribute to effective
delivery of a presentation?
What differentiates an excellent oral presentation apart from
an average one?
What are some distracting habits that prevent your audience
from being vested in your presentation?
How do you use a presentation to further your career goals?
Tools of the trade:
successful strategies for research in medicine
Publishing your results
Publishing your research: “Anatomy of a paper”
FMR 2014: Presented by Dr. Dario Torre
How to get your manuscript out of
the drawer and onto the shelves
Tools of the trade:
successful strategies for research in medicine
DUCOM resources for conducting
research:
Office of Research (Dr. Kenny Simansky)
Sharepoint website
DUCOM Research Portal:
Sharepoint: Funding Resources for Research
 Funding opportunities (internal and external)
Professional Enrichment and Growth Grant; CTRI seed grants, Mary
Petit Dewitt, Foundations, etc.
http://www.drexelmed.edu/home/Research.aspx
https://sharepoint.drexelmed.edu/research/SitePages/Home.aspx
Tools of the trade:
successful strategies for research in medicine
Identification of funding sources
DUCOM Research Portal:
Sharepoint: Funding Resources for Research
https://sharepoint.drexelmed.edu/research/SitePages/Home.aspx
Tools of the trade:
successful strategies for research in medicine
Writing grant proposals
Obtaining funding: successful strategies in
grant writing
FMR 2014: Presented by Dr. Chris Vinnard
Preparing successful grant proposals to receive
funding from institutions, foundations or corporation
requires careful research, meticulous preparation, and
strategic writing.
Tools of the trade:
successful strategies for research in medicine
ongoing training throughout the academic
year
The Office of Faculty Affairs and Professional
Development
2014 Faculty Leadership and Excellence Seminar Series
“Understanding Appointments and Promotion at DUCOM”
Panel discussion of positive strategies to put your career on the right path
“Culture Competency” by Dr. Ana Nunez
“Wellness for the Educator” by Dr. Steve Rosenzweig
“Improving Patient Safety” by Dr. John Clarke
“Turning every day activities into scholarly activity”
“Creating an academic portfolio”
“Assembling a research team and maximizing synergy”
Mission:
**To support our faculty in their
scholarly activity
**To build and expand leadership
skills of DUCOM faculty as
academic leaders.
“The Art of Negotiation”
“Academic advancement for clinical educators”
The Office of Faculty Affairs and Professional Development offers seminars, workshops,
and resources for faculty and academic leaders utilizing interactive dialogue and panel
discussions. The broad range of seminars and programs, services, and resources are
designed to support the faculty excellence in teaching, research, and clinical service and
outreach.
https://www.drexelmed.edu/Home/FacultyAffairs.aspx
Women in Medicine and
Science Committee
“Brown Bag Lunch” Seminars
Women in Medicine and Science Committee Mission
The mission of the Women in Medicine and Science Committee (WIMSC) is to support and
promote the professional development, career advancement and leadership of women in
medicine and science at Drexel University College of Medicine.
The brown bag lunch lectures are open to Drexel University College of Medicine men and
women faculty and trainees (medical students, graduate students, residents, fellows, etc.)
with the belief that all faculty benefit from career development training and enhanced
mentoring and networking.
The 2014 Brown Bag Lunch seminar series is a lecture platform on topics related to:
**CV preparation
**Lifelong investments
**Work-life balance and time management
**Caring for aging parents
**Laboratory management
**Conflict resolution and management
http://www.drexelmed.edu/Home/FacultyAffairs/WomeninMedicineScienceCommittee.aspx
Tools of the trade:
successful strategies for research in medicine
Online video recordings and handouts for
research resources
Professional Development Video Library
http://www.drexelmed.edu/Home/FacultyAffairs/ProfessionalDevelopment.aspx
Questions
Michele A. Kutzler, PhD
Drexel University College of Medicine
Assistant Dean of Faculty Affairs and Professional Development
Assistant Professor of Medicine
Division of Infectious Diseases & HIV Medicine
Assistant Professor of Microbiology and Immunology
Member of the Institute of Molecular Medicine & Infectious Disease
Member of the Research Center of Excellence for Immunology and Vaccine Science
Address:
Room 6206 New College Building
MS 461
245 N. 15th Street
Philadelphia, PA 19102
Contact info:
Office (215) 762-3487
Lab (215) 762-3602, -3608
Fax (215) 762-3031
Mkutzler@drexelmed.edu