Transcript Clinical Research Group - Drexel University College of

Clinical Research Group
New Employee Orientation
Message from the Vice Dean for Research:
Kenny J. Simansky, Ph.D.
Drexel University College Of Medicine, Vice Dean for Research
The nature of research activity in a medical school defines the intellectual
climate of the institution. Experimental investigation of the mechanisms and
consequences of disease and trauma provides insight for developing novel
strategies to maintain wellness and treat sickness. Systematic evaluation of
those strategies—changes in lifestyle; new pharmacological, molecular and
other manipulations of cellular targets; new implanted sensors, artificial
tissues and devices—establishes which to adopt for clinical practice and
which to discard.
This entire research enterprise should and must create the culture in which
students are taught medicine as a rational, evidence-based approach to
improving human health. We are proud of the internationally recognized
research programs conducted by our basic scientists and of the many
complementary efforts in clinical science and clinical care conducted by our
faculty. Our Clinical Research Group provides the foundation for testing new
treatments in carefully supervised trials in our patients.
Message from the Vice Dean for Research
Kenny J. Simansky, Ph.D.
Drexel University College Of Medicine, Vice Dean for Research
Translating biomedical discoveries from the wet laboratory to the bedside
defines a great academic medical center and is the primary emphasis of the
National Institutes of Health. Thus, Drexel University College of Medicine will
be investing significant resources in expanding our translational and clinical
research programs during the next five years.
Drexel Medicine’s Strategic Plan for 2007-2012 includes initiatives that
emerged from existing strengths in research on the mechanisms, prevention
and treatment of chronic pain; autism and autism spectrum disorders; viral,
protozoal (malarial) and other infectious diseases; and inflammation and its
relationship to the development of cancer. Of course, our strengths and
successes in research extend beyond those areas, and I invite you to explore the
web pages of our departments, institutes and centers. In addition, interactions
with faculty from other schools and colleges of Drexel University will continue
strategic developments in neuroengineering and other areas of bioengineering.
Message from the Vice Dean for Research
Kenny J. Simansky, Ph.D.
Drexel University College Of Medicine, Vice Dean for Research
These initiatives will apply our leadership in technology to assisting recovery
of patients suffering from trauma and diseases of the nervous system and to
the healing promised by emerging methods of regenerative medicine. Our
institution has a special history of educating women physicians and scientists
for more than 150 years. This tradition is highlighted now in the form of the
Institute for Women’s Health and Leadership.
Thus, we are particularly excited by our plans to expand our scientific efforts
in women’s health and in gender-based biomedical research. In collaboration
with our colleagues from Information Science and Technology, Nursing, and
Public Health, we will be applying biomedical informatics, health informatics
and epidemiology to identifying new areas for scientific investigation and for
optimizing clinical care. Overall, we look forward enthusiastically to
continuing to grow and diversify our programs of scientific discovery towards
better serving our patients in the future.
Meet the Office Of Research
Management Team
• Kenny J. Simansky, PhD
Vice Dean for Research
New College Building, 19116
Phone: (215) 762-8949
Email: [email protected]
Dr. Kenny Simansky is the Vice Dean for Research. Simansky provides
leadership and strategic planning as related to basic and clinical research
activities.
Meet the Office Of Research
Management Team
• Noreen M. Robertson, DMD
Director of Research Program Development
New College Building, 11301
Phone: (215) 762-4889
Email: [email protected]
Dr. Noreen Robertson is the Director of Research Program Development.
Robertson provides direction and fosters research in collaborative,
interdisciplinary research programs as related to basic and clinical.
Meet the Office Of Research
Management Team
• Donna J. Walsh, RN, BSN, MS, CIP, CCRC
Chief Operating Officer, Clinical Research Operations
Three Parkway Building, 10th Floor, Suite 1000
Phone: (215) 255-7803
Email: [email protected]
Donna Walsh is the Chief Operating Officer of Clinical Research Operations
and the Clinical Research Group (CRG). Ms. Walsh provides leadership and
is responsible for all infrastructural support and oversight of clinical trials
within the College of Medicine.
Meet the Office Of Research
Management Team
• Richard Huneke, DVM
Executive Director of University Laboratory Animal Resources (ULAR)
Phone: (215) 762-7970
Email: [email protected]
Dr. Richard Huneke is Executive Director of ULAR. Huneke directs the
critical mission of housing laboratory animals for research and providing care
that meets the highest veterinary standards for good clinical practice and the
regulations of accrediting agencies and governmental authorities.
Meet the Office Of Research
Management Team
• Lauren E. May
Senior Coordinator
New College Building, 19118
Phone: (215) 762-8961
Email: [email protected]
Lauren May is the Senior Coordinator. Ms. May coordinates the processes
required to develop and foster research activities.
Meet the Office Of Research
Management Team
• Danyelle P. Blackwell
Executive Assistant
New College Building, 19th Floor
Phone: (215) 762-8949
Email: [email protected]
Danyelle Blackwell is the Executive Assistant to the Vice Dean for Research.
A Message from the Chief Operating Officer,
Clinical Research Group –
Donna J. Walsh, RN, BSN, MS, CIP, CCRC
Welcome to the Clinical Research Group. Clinical trials are studies that are
sponsored or supported by a private company and involve an evaluation of a
drug, device or technology. These studies include Phase I through IV human
research. Drexel Medicine and/or its affiliated hospitals serve as a site and/or
the sponsor in these studies.
We are committed to serving three groups of clients – the public, industry, and
our researchers and staff. Whether you are interested in learning about or
participating in a clinical trial . . . or you are interested in Drexel Medicine or
its affiliate hospitals as a research site for your next clinical trial . . . or you are a
researcher or staff member at Drexel Medicine or one of its affiliated hospitals
looking to start or manage your clinical trial – you have come to the right
place!
Clinical Research Group (CRG) - An Overview
Who We Are
Drexel University College of Medicine is committed to supporting and
facilitating clinical research, and recognizes that industry plays a significant
role in the discovery of new and better medical treatment.
The Clinical Research Group (CRG) was created to provide a one-stop service
to facilitate clinical trial management. CRG consists of administrative, clinical,
financial, legal and regulatory professionals, who work as a team to smoothly
and efficiently establish clinical trials at the College of Medicine and its many
affiliated hospitals. Whether you are a small entity or a large one, CRG strives
to create a strong working relationship that supports not only current clinical
trials, but also future trials.
Clinical Research Group (CRG) - An Overview
Who We Are
Our Mission:
Established in 2003, the Clinical Research Group`s (CRG) mission is to
enable Drexel University College of Medicine (DUCOM) to achieve an
environment of research excellence, by supplying a supportive infrastructure,
developing sound business practices, and fostering a culture of innovation in
our research activities.
Clinical Research Group (CRG) - An Overview
Who We Are
Our Advantages:
• World-class health-care centers in Eastern Pennsylvania, New Jersey and
counting
• Experienced investigators and coordinators with many years of service
• Use of Western Institutional Review Board (IRB) for industry-sponsored
clinical trials
• Centralized office to fostering industry-sponsored research at more than one
research site
• Stable patient population
Clinical Research Group (CRG) - An Overview
What We Do
Our Services:
• CRG is dedicated to assisting in placing and conducting a clinical trial at
Drexel University College of Medicine. A partial list of our services includes:
– Conducting training seminars for DUCOM's Clinical Investigators and
Coordinators in Good Clinical Practices (GCP)
– Operating with standards of process and policy, by providing a one-top resource,
assisting Investigators and sponsors with implementation and administrative
services in clinical studies.
– Managing oversight to clinical sites and providing recruitment strategies
– Providing public awareness to the benefits of participating in clinical trial research
Clinical Research Group (CRG) - An Overview
What We Do
Our Services continued:
- Leading teams of highly skilled Research Investigator/Coordinator Professionals,
by providing a platform in which to enhance knowledge of process through
presentations and mentorship
- Implementing a multi-disciplinary approach to assessing high risk research and its
impact to the University
- Accessing analytical support and clinical trial database/metrics
- Negotiating and developing study contracts and budget processes
- Collaborating with Drexel University and their international reputation for
technology, by offering services to enhance our translational capabilities in clinical
trials
- Expanding DUCOM's research relations with affiliate sites and community
partners.
Meet the Team
Clinical Research Group (CRG)
Operations:
Donna J. Walsh
Chief Operating Officer, Clinical Research Operations
(215) 255-7803
[email protected]
Theresa M. Piechowski
Research Program Administrator
(215) 255-7804
[email protected]
Adam Fuhrer
Research Administrative assistant
(215) 255-7879
[email protected]
Legal/Contract:
Priya Sankar
Assistant General Counsel & Associate Director
(215) 255-7845
[email protected]
Stephanie Peterson
Contract Specialist
(215) 255-7805
[email protected]
Financial/Budget:
Anna Wong
Senior Financial Analyst
(215) 255-7806
[email protected]
Douglas Livolsi
Financial Coordinator
(215) 255-7876
[email protected]
Sally Eells
Financial Coordinator
(215) 255-7745
[email protected]
Research Management – Affiliate Sites:
Esther Nkrumah
Assistant Director, Clinical Research Management
St. Peter’s University Hospital, New Brunswick, NJ
(732)745-8600 X5143
[email protected]
Meet the Team
Clinical Research Group (CRG)
Clinical:
Clinical continued:
Elizabeth Connor
Karen Skinner
Senior Clinical Research Nurse Coordinator
(215) 762-3393
[email protected]
Clinical Research Nurse coordinator 111
(215)762-4662
[email protected]
Andrew Francis
Josh Zigmont
Clinical Research Nurse Manager 1 – HUHSt. Christopher CH
(215) 427-5360; (215)961-8225
[email protected]
Data Coordinator
(215) 255-7879
[email protected]
Marjorie Hepler
Research Management/Training and Development:
Clinical Research Nurse Manager 1 – HUH-PPP
(215)2 55-7878
[email protected]
Anne Johnson
Research Nurse Coordinator
(215) 255-7877
[email protected]
David Phuong
Clinical Research Nurse Coordinator 11
(215) 427-7911
[email protected]
Marcellina Oparaoji
Associate Director, Clinical Research Management & Training
(215) 255-7807
[email protected]
Clinical Research Group Location:
1601 Cherry Street, Mail Stop 101021
3 Parkway Building, 10th Floor Suite 1000
Philadelphia, PA 19102
Phone: 215-255-7879
Fax:
215-255-7885
Clinical Research Group Organizational Chart
Our Affiliates
Drexel College Of Medicine (DUCOM)
• Drexel University College of Medicine, a new name just a few years ago, is the
consolidation of two venerable medical schools with rich and intertwined
histories: Hahnemann Medical College and Woman’s Medical College of
Pennsylvania. Established in 1848 and 1850, respectively, they were two of the
earliest medical colleges in the United States, and Woman’s was the very first
medical school for women in the world.
• Today, with over 1,000 medical students, Drexel University College of
Medicine (DUCOM) has the largest medical student enrollment of any private
medical school in the nation. Graduate students number more than 500, and
the College is the academic partner in the education of some 550 medical
residents. There are more than 700 clinical and basic science faculty, and more
than 1,700 affiliate and volunteer faculty.
Our Affiliates
Drexel College Of Medicine (DUCOM)
• The College of Medicine's main campus, Queen Lane, is in a suburban-like
setting in the East Falls section of Philadelphia. Additional facilities are
located at the Center City campus, which includes Hahnemann University
Hospital. Our Pediatrics Department is at St. Christopher’s Hospital for
Children, and Psychiatry is based at Friends Hospital. Students can receive
clinical education at 25 affiliated hospitals and ambulatory sites chosen for
commitment to teaching as well as medical excellence.
• DUCOM's clinical practice, Drexel University Physicians®, is a patientfocused practice emphasizing quality, innovation and community service, and
enhanced by physician involvement in the research and educational programs.
Our Affiliates
Friends Hospital
• Located on a 100-acre campus in Northeast Philadelphia
• Inpatient facility with 24-hour nursing care in all units
• Crisis Response Center provides evaluations and admissions 24 hours a day,
7 days a week.
• Children and Adolescent Services offers a range of inpatient hospital
services for children and adolescents suffering from behavioral and emotional
problems.
• Inpatient hospital services: For ages 5-12 (children) and 13 -18
(adolescents).
• Eating Disorders Program: Helping children and adolescents, ages 13+,
with anorexia, bulimia, and binge eating disorder, through inpatient services
for both males and females
• Adult Services: An inpatient program for adults ages 18 to 65.
Our Affiliates
Friends Hospital
• Older Adult Services: The first program in the Delaware Valley specifically
designed for elderly with a mental illness.
• Inpatient treatment: For individuals with anxiety disorders, depression, other
affective disorders, schizophrenia and chronic mental disorders, personality
disorders, or any other mental or emotional disorder
• The Greystone Program: Providing long-term residential services for
persons with severe and persistent mental illness
• The Women's Program: Offering psychiatric and psychological services
through an inpatient program specifically designed for women
• Dual Diagnosis Program: Designed for patients with a primary psychiatric
diagnosis and secondary substance abuse issue
Our Affiliates
Hahnemann University Hospital
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Established in 1885
Located in the heart of Philadelphia
541 licensed beds
9th-largest hospital, in US? in Pennsylvania?
Ranked one of nation’s top 50 hospitals for heart care (U. S. News & World
Report, 2007)
• Region’s first and only artificial heart implant (5th in the world)
• Region’s first and only designated-training site for the recently FDA-approved
carotid stent system
Our Affiliates
Hahnemann University Hospital
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Site of one of the region’s first kidney transplant, in 1963
Site of region’s first bone marrow transplant, in 1976
Region’s first designated Level 1 trauma center
Region’s first regional air medical program (MedEvac)
Region’s first partnership with The Wellness Community for on-site Cancer
support groups
• Region’s first robotic bariatric and gynecologic surgeries
• More than 35,000 Emergency Department visits annually.
Our Affiliates
St. Christopher's Hospital for Children
• Located in Philadelphia
• 170-bed pediatric hospital
The hospital provides a wide range of pediatric, medical and surgical
specialties through its affiliation with Drexel University College of Medicine.
With a medical staff of more than 270 pediatric specialists, St. Christopher's is
a Level I Pediatric Trauma Center and provides programs such as kidney
transplantation, cancer treatment, burn and wound care, minimally invasive
surgery, and open heart surgery for children of the greater Philadelphia area
and around the world. The hospital is fully accredited by the Joint
Commission, the nation’s oldest and largest hospital accreditation agency.
Our Affiliates
St. Christopher's Hospital for Children
The hospital is home of the Cystic Fibrosis (CF) Center, which is accredited
by the National Cystic Fibrosis Foundation and is part of the Tenet
Healthcare System. Through the Center’s affiliations with Drexel University
College of Medicine, an Adult CF Program is available at Hahnemann
University Hospital in order to better transition individuals living with CF
from childhood to adulthood.
In addition, expert training is available for medical students, residents and
allied health professionals in the care of CF.
Our Affiliates
Saint Peter's University Hospital
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Incorporated in 1908
Located in New Brunswick, NJ
478 bed teaching hospital offering specialized care from pre-mature babies
to geriatrics
10th hospital in the nation to achieve Magnet status (a rigorous process that
demonstrates the excellence in nursing for the hospital)
Co-founder of the Cancer Institute of New Jersey (CINJ) and currently a
CINJ Clinical Research Affiliate
Our Affiliates
Saint Peter's University Hospital
Specialty services include:
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Cardiac care for adults offering cardiac catheterization and angioplasty
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Diabetes care and control center for adults and children
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Health center for women
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A full service Oncology program
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Dorothy B. Hersh regional child protection center
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Specialized geriatric services, provided through its Comprehensive Care
Group at Monroe, Adult Medical Center at Monroe and Margaret
McLaughlin McCarrick Care Center in Somerset.
Who we work with – CRG partners
Office of Regulatory Research Committees (ORRC)(IRB/WIRB)
Ensures the protection of human subjects through:
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Compliance with federal guidelines
Continuous review of regulatory documentation
Responsible for providing study approval
Proper reporting of study related injuries
Human Subject protection through consent form language
Location: Office of Regulatory Research Committees
1601 Cherry Street, 3 Parkway Bldg., Suite 10-444,
Philadelphia, PA. 19102
Phone numbers: 215-255-7857 Fax: 215-255-7874
Who we work with – CRG partners
Office of Research Compliance & Administration (ORCA)
The Office of Research Compliance and Administration is dedicated to enhancing
University research and sponsored activity by providing excellent support services to
our faculty.
ORCA Responsibility Areas:
• Assist in project conceptualization and planning
• Provide general guidelines and assistance for proposal preparation and award
administration
• Review, approve and submit all sponsored project proposals on behalf of the
University
• Negotiate and accept sponsored awards; Negotiate subcontracts to other institutions
• Establish sponsored project cost centers, monitor performance, assist in compliance
review of spending in accordance with University and sponsor policies and procedures
and OMB Circulars A-21 and A-110, and assist Private Investigators in the financial
closeout of the project
Who we work with – CRG partners
Office of Research Compliance & Administration (ORCA)
(contd)
• Interpret federal, University and sponsor regulations, policies and guidelines
• Prepare invoices and financial reports; Collect cash
• Maintain proposal and sward database and prepare management reports; Provide
training and support for faculty and staff during the sponsored project life cycle
• Coordinate and facilitate audits
• Monitor programmatic and financial compliance
Located at: 3201 Arch Street, Suite 100, Drexel University Main Campus
Philadelphia, PA, 19104
Phone Numbers: 215-895-5849 Fax: 215-895-6699
Who we work with – CRG partners
Investigational Drug Research Pharmacy
The drug research pharmacist has an integral part in drug research studies.
• The research coordinator will work alongside the pharmacist to fabricate a
budget for utilizing pharmacy services
• Pharmacy is responsible for drug storage and accountability
• Mixing and dispensing of drug the responsibility of pharmacist
• If subject is to be discharged on study medication the research pharmacist is
to be contact
Located at: Hahnemann Hospital, Basement, North Tower, Denise Lai Tomako,
Pharm.D
Phone Numbers: 215-762-1140
Who we work with – CRG partners
Hahnemann Laboratory Services
An important resource for research coordinators who are conducting studies which
require lab samples and/or lab equipment.
Hahnemann University Laboratory Services
• Assist in obtaining CLIA and CAP for coordinators
• Assists in obtaining lab value ranges for Hahnemann University Hospital
• Assist in obtaining coordinators access into Sunquest system for lab values
• Assist with price negotiations for research laboratory services and laboratory
equipment rental
Located at: Hahnemann Hospital, 5th Floor, North Tower
Phone Numbers: 215-762-7596
Who we work with – CRG partners
Cashier's Office:
This office assist with procurement of subject reimbursement funds
• Provides petty cash for study related payments
• Open Monday-Friday from 9am-5pm
Located at: Hahnemann Hospital , 1st Floor, North Tower (lobby)
Phone Numbers: 215-762-8480
Who we work with – CRG partners
Research Committee College of Medicine:
Established under the existing Bylaws of the College of Medicine,
the Research Committee serves as the premier body of faculty,
which provides required oversight for the development and implementation of
strategic growth initiatives in research and graduate education missions.
Membership is composed of one member of each Department of the Drexel
University College of Medicine. Members are appointed for a term of four (4)
years, with staggered terms to permit replacement of approximately twenty- five
percent (25%) of the Committee each year. The following serve as permanent exofficio members of this Committee, without vote: Directors of Centers and
Institutes, Legal Counsel.
Who we work with – CRG partners
Research Committee College of Medicine continued:
Committee Chairmanship: The Research Committee
is chaired by the Associate/Vice Dean for Research, Drexel University College of
Medicine – Dr. Kenny Simansky
Meetings are held every second Friday of the month at 8:00 a.m. in the Board
Room, NCB. Except for the regular members, attendance is by invitation only.
Who we work with – CRG partners
Research Committee College of Medicine:
Responsibilities of the Committee include serving as a primary advisory group
to the Dean on matters relating to research.
• The Committee reviews, periodically, the effectiveness with which the broad
research objectives of the Drexel University are being achieved and will report
their recommendations to the Dean
• The Committee helps coordinate information regarding equipment that can
be utilized cooperatively for research efforts
• The Committee recommends the development of specific institutional
resources and facilities as they apply to research
• The Committee recommends guidelines and procedures for utilizing
institutional resources for research
• The Committee advises the Dean regarding the allocation of institutional
research support grants for specific projects
Who we work with – CRG partners
CRG helps coordinate clinical research operations in the following areas and
more, within DUCOM:
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Clinical Departments
Administrative Departments
Institutes
Centers
Who we work with – CRG partners
Clinical Departments:
DUCOM
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Anesthesiology
Cardiothoracic Surgery
Dermatology
Emergency Medicine
Family, Community and Preventive
Medicine
• Medicine
• Neurology
• Obstetrics and Gynecology
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Ophthalmology
Orthopaedic Surgery
Otolaryngology
Pathology and Laboratory
Medicine
Pediatrics
Psychiatry
Radiation Oncology
Radiologic Sciences
Surgery
Who we work with – CRG partners
Academic Publishing Services (APS):
APS provides professional editorial assistance for DUCOM faculty, residents,
and postdoctoral fellows, especially for First-time Authors, Preparing a Paper
for Publication:
Services APS provides:
• Document editing and proofreading
• Journal-specific submission requirements profile
• Book project management
• Reference formatting
• Permission requests to use copyrighted material
• Illustration preparation assistance
• On-line manuscript submission and Publisher communication
• Helps publishers eliminate language and formatting errors that distract
reviewers
• Costs nothing!
Who we work with – CRG partners
DUCOM Institute for Women's Health and Leadership:
The Institute (IWHL) and its core programs in leadership, education, research,
outreach/advocacy, and the Archives and Special Collections are co-located in
a new wing bearing the Institute’s name on the Queen Lane campus of the
medical school.
IWHL is perceived as an essential component of the College of Medicine, as
indispensable as the Departments of Medicine, Ob/Gyn and Pediatrics, and
continues to be a catalyst for collaboration in women’s health and leadership
within DUCOM, across Drexel University and in the Philadelphia community,
regionally and nationally.
The Center for Women’s Health Research is fully operational under the
leadership of a renowned researcher and is bringing national recognition to
Drexel for its trailblazing agenda.
Who we work with – CRG partners
DUCOM Institute for Women's Health and Leadership:
Named in 1996 by the U.S. Department of Health and Human Services as a
National Center of Excellence in Women's Health, one of only six such
designations in the nation at the time, the Institute has set its professional sights
on developing resources and programs that will bridge the gaps in women's
health and leadership.
The Institute for Women's Health and Leadership, with its roots in a century and
a half of tradition, is defining its worth through a determination to make history,
not just record it.
Who we work with – CRG partners
Institute for Molecular Medicine and Infectious Disease:
The Drexel University College of Medicine Institute for Molecular Medicine and
Infectious Disease is a collaborative inter-campus enterprise focused on research,
diagnosis, treatment, prevention, and clinical management of infectious disease,
cancer, and metabolic and genetic disorders.
The Institute facilitates the development and expansion of 14 Research Centers
of Excellence (RCEs) and 2 Administrative Centers. In parallel with this
objective, the Institute facilitates the training and development of graduate
students, postdoctoral fellows, residents and junior faculty.
Who we work with – CRG partners
Drexel Institute for Biotechnology and Virology Research:
The Drexel Institute for Biotechnology and Virology Research (DIBVR) is a new
research division, established in July 2004 by Drexel University College of
Medicine, and is the result of an innovative academic partnership between Drexel
University and the Hepatitis B Foundation, a national nonprofit research
organization.
DIBVR faculty share space and resources with the Hepatitis B Foundation and
its research institute in the 62,000 square foot Pennsylvania Biotechnology Center
located in Doylestown, PA.
Who we work with – CRG partners
Institute for Molecular Medicine and Infectious Disease:
The Institute also provides an organized framework to guide the development of
inter-campus, inter-college, and inter-unit research initiatives across the
University, stimulating functional interactions across the basic and clinical science
boundaries and increasing the extent and quality of these interactions.
The Institute strives to enhance visibility of Drexel University and
interactions of the University with other academic, industrial, and
governmental organizations at the regional, national, and international levels with
respect to research concerning the treatment and prevention of human disease.
Who we work with – CRG partners
DUCOM Centers:
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Adult Cystic Fibrosis Center
Center for Study of Hospital-Acquired Infection
Drexel Autism Center
Memory Disorders Center
National Institute on Drug Abuse Center of Excellence
Center for Molecular Diagnostics and Genome Research
Who we work with – CRG partners
Office of Research Technology Commercialization:
The overall philosophy of Technology Commercialization is to set in motion an
interactive process that aims to provide significant benefits to the inventors,
the university, the business community and the general public.
Their goals are to:
• Work with industry leaders, venture capitalists and the university researchers
to create new product ideas for commercial development
• Determine and improve the commercial viability and commercial success
potential for new inventions
Who we work with – CRG partners
Office of Research Technology Commercialization:
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Foster a team spirit among industry, University researchers and the Research Office to
formulate strategies for success in the commercial marketplace and the medical
community
Encourage the development of an environment for creativity, innovation and
entrepreneurship
Incentivize the research community through shared rewards with business and
industry
Help the University, through its technological prowess, participate in economic
development for the well-being of the community, the region and the nation by
increased business competitiveness in a global marketplace
Located in the Laurence A. Baiada Center on Arch Street between 32nd and
33rd, across from Buckley Field
Who we work with – CRG partners
DUCOM Office of the General Counsel:
The Office of the General Counsel represents Drexel University and the Drexel
University College of Medicine.
• It provides legal services and representation to all parts of Drexel University
and the Drexel University College of Medicine on all of their campuses: the
University City Main Campus, Center City Campus and the Queen Lane
Campus
• The Office of the General Counsel is also responsible for engaging outside
counsel, when deemed appropriate, in order to provide additional expertise
and support
Who we work with – CRG partners
DUCOM Office of the General Counsel:
• Their services include litigation and risk management, contract negotiation,
drafting and review, legal and regulatory compliance, and legal advice and
counsel in business transactions, labor and employment, real estate, intellectual
property and technology transfer matters, and other matters impacting
institutions of higher education
• The Office of the General Counsel provides legal counsel to the trustees,
officers and employees of Drexel University and the Drexel University College
of Medicine in matters relating to their services on behalf of each
Note:
The Office of the General Counsel cannot provide legal advice or
representation to individual members of the University community in
connection with matters against the University or with other personal matters.
Who we work with – CRG partners
DUCOM Office of the General Counsel:
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A member of the DUCOM Office of the General Counsel represents the University in
transactions relating to research and compliance.
The member advises the Clinical Research Group, Office of Research Compliance and
other University departments on various issues including HIPAA, intellectual property,
conflict of interest, compliance, and other research-related issues.
In addition, the member manages the negotiations of agreements for clinical research
conducted at the College of Medicine.
This representative also works with the Clinical Research Group and University
researchers in developing research affiliations and collaborations.
Located at: 1601 Cherry Street, Suite 10627 Philadelphia, PA 19102
Phone: 215.255.7835 Fax: 215.255.7856
Who we work with – CRG partners
The Office of Equality and Diversity (OED):
• OED is committed to promoting, supporting and providing resources to
sustain a living, learning and working environment of diversity, equality,
fairness, inclusion and respect where all members of the University
community are valued
• OED is responsible for ensuring that the University complies with its own
policies and with federal, state and local laws prohibiting discrimination and
harassment based upon race; color; religion; gender; pregnancy; national
origin; age; disability; sexual orientation, identity, and expression; and veteran
status
• In addition to investigating complaints, OED utilizes various conflict
resolution processes to address complaints of discrimination, harassment and
retaliation
Who we work with – CRG partners
The Office of Equality and Diversity (OED):
To further uphold its mission, the Office of Equality & Diversity offers the
following training and educational opportunities:
Training:
Without Regard is a mandatory discrimination, harassment and retaliation
prevention training program for all faculty and staff.
Workshops:
Several workshops are offered by request, on a range of topics; such as:
• Discrimination, Harassment, and Retaliation Prevention
• Diversity Recruitment and Hiring Practices
• Diversity and Inclusion, Conflict Resolution Skills
Located at 3201 Arch Street, Suite 210
Philadelphia, PA 19104
Who we work with – CRG partners
DUCOM Human Resources:
Mission: Enable increased faculty, staff and student engagement through a
human capital approach that attracts, rewards, develops and retains diverse,
quality talent.
For HR questions and/or requests, we suggest you contact the following:
• Benefits Administration:
Questions regarding your employee benefits administered by HR.
Note: for Dragon Plan questions, please call the Benefits Service Center @
866-806-0950
• Recruitment / Employee Relations:
Questions related to submitted recruitment forms; Dept Mgrs requesting to
post student positions online; or employee issues that may require private
considerations.
Who we work with – CRG partners
DUCOM Human Resources:
• Policy and Procedures:
Questions that pertain to one or more of HR policies as shown in the website
• Request a call back from a HR Representative:
For questions not related to any of the above categories
Located at 3201 Arch St. Suite 430
– Phone: 215-895-2850 - Fax: 215-895-5813
– Email: Click 'Ask HR' feature
Clinical Research Resources
Guides for Grant Applications: use link to access topics below
http://new.drexelmed.edu/Home/Research/ResourcesforResearchers/NIHReso
urces.aspx
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NIH Office of Extramural Research
Funding Opportunities and Notices
NIH Forms and Applications
Types of Grant Programs
Research Training Opportunities
Submission Dates and Deadlines
New Investigator Program
Clinical Research Resources
Educational Information for Grant Applications: use link for
topics below
http://new.drexelmed.edu/Home/Research/ResourcesforResearchers/NIHRes
ources.aspx
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Getting Started at NIH
Grants Tutorials
Grant Writing Tip Sheet
Resources for New Investigators
Data Sharing Policy
Model Organism Sharing Policy
Clinical Research Resources
How to Start a Trial:
• Priya please send me your item for here.
Thanks
Clinical Research Resources
Research Coordinator Responsibilities
• The primary responsibility of the research coordinator is to facilitate the daily
activities required of clinical research
• Report directly to the Principal Investigator
• Ensures required training has been completed by study personnel
• Always maintain site in anticipation of FDA audit
• Assist PI with feasibility for new trials based on staff and resources
• Provide mentorship to new research coordinators
Clinical Research Resources
Study specific responsibilities of the Research Coordinator
• Collaborate with financial team to develop study budget
– Standard of Care vs. Non Standard of Care
• Study Documentation
– Set up and maintain regulatory binder
– Create required source documentation for the study
• Submission preparation and review
– Fabricate consent form and have PI review for accuracy
– COI Forms completed by all study personnel
– Has required training been completed?
Clinical Research Resources
Research Coordinator Responsibilities cont.
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Performing Research
– Training
• Have all study staff complete required study training
• Train nursing staff on procedure requirements of the study
– Enrollment
• Screening patients
– Inclusion / Exclusion Criteria
» PI to provide final confirmation and sign
• Remind PI of enrollment status of the study and enrollment goal
• Maintain screen failure log
– Documentation
• Collect appropriate data using CRF source doc’s
• Maintain subject data according to University and Sponsor policies
• Document communication
– Telephone logs
– Emails
– Meeting minutes
• Report AE/SAE according to sponsor/IRB requirements
Clinical Research Resources
Responsibilities of the Principal Investigator
• A Principal Investigator has absolute responsibility for the overall
conduct of a sponsored project, including all technical, programmatic,
financial, compliance and administrative aspects. The Principal
Investigator is responsible for controlling the technical direction and
academic quality of the project, and will ensure that a sponsored project is
carried out in compliance with the terms, conditions and policies of the
Sponsor and the University.
• The principal investigator is responsible for ensuring a research study is
conducted according to the investigation plan
Clinical Research Resources
Responsibilities of Principle Investigator
• Providing protection of rights, safety, and welfare of human subjects
– Primary Investigator should educate subject on purpose, risks, benefits, and
procedures of the study
– Study subjects should have access to the Primary Investigator at all times if any
study related issues should arise
– Concrete understanding of the study protocol and device/drug that is being
studied
– Go over safety monitoring reports to have a better sense of risks of the study
– Meet with research coordinators on a regular basis
– In the event human subject is injured, Primary Investigator should ensure that
adequate medical care is provided
Clinical Research Resources
Principle Investigator Study Specific Responsibilities
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Delegation of study related tasks appropriately
Determine study feasibility at research site
During screening phase, provide final feedback on subject I/E criteria.
AE/SAE’s are reported in timely fashion
Follow protocol, complete required procedures, and avoid deviations
Would our site be ready for an FDA audit?
Clinical Research Resources
Eligibility for Principal Investigator Status
Granted to all regular full time faculty including
• Emeriti, research professors and officers of the University who hold
director-level administrative positions.
Visiting scholars will not be granted Principal Investigator status
under any circumstances
• Student Investigators are not eligible for Principal Investigator status, but
may be permitted to conduct sponsored projects under the direction of a
faculty advisor
• Postdoctoral fellows, lecturers, adjuncts, instructors and other
professional staff may be eligible for Principal Investigator status in
certain circumstances as described in the next slide
Clinical Research Resources
Process for a Petition to Grant Principal Investigator Status
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Individuals who do not meet University eligibility requirements may be granted
Principal Investigator
The petition for Principal Investigator status is must be specifically approved on a
case-by-case basis
A petition to request Principal Investigator status should be submitted to the
respective dean, director or vice president for first review and approval
– The applicant’s review package must include:
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A letter of endorsement from a senior faculty member
A letter of endorsement from the department head
The approval of the respective dean, director or vice president
The applicant’s curriculum vitae
The applicant’s written request for consideration which must include the research plan, the
proposed sources for external support, a space utilization summary and a statement of how the
project will further the University’s mission
All requests must be approved by the head of the applicant’s academic or business unit
and sent to the attention of the Vice Provost for Research, Office of Research
Compliance and Administration, 3201 Arch Street, Suite 100
Clinical Research Resources
Regulatory Requirements
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IRB submission (full review)
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Project Submission Transmittal Form
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Full Review/Expedited Review Combined Form
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Co-Investigator Form if more than 2 Co-Investigators involved in study
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Conflict of Interest Form
• Primary Investigator, Sub-Investigator, Study staff
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Research Proposal or NIH Grant (Thesis/Dissertation Proposal)
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Investigator’s Brochure (If Applicable)
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Informed Consent
• Review by Primary Investigator
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Assent Form
• Pediatric Studies
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Copy of Advertisement (If Applicable)
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Data Collection Instrument (If Applicable)
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Radiation Safety Form (If Applicable)
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Bio-safety Form for Risk Groups 3 & 4 (If Applicable)
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Human Specimens Study Registration Form (All Risk Groups)
Clinical Research Resources
Important addresses and Phone numbers:
Clinical Research Group:
phone– (215) 255-7879
fax– (215) 255-7885
Help Desk:
phone– (215) 762-1999
Hahnemann Library:
phone– (215)762-7631
Center City Bookstore:
phone– (215) 762-7629
Clinical Research Resources
When to use DUCOM services:
Human Resources:
http://www.drexel.edu/admin/hr_hs/
Comptroller`s Office
http://www.drexel.edu/depts/compt/payroll/basics_med.html
Clinical Research Resources
When to use Drexel University services:
Gym
http://www.drexeldragons.com/sports/2007/2/14/membership_fees.aspx?tab=
membershipinformation
Shuttle
http://www.drexel.edu/facilities/ShuttleBrochure.pdf
Clinical Research Resources
When to use Drexel University services (cont):
Holiday Schedule
DAY
Friday
Monday
Monday
Thursday
Friday
Friday
Friday
Monday
Monday
DATE
July 3, 2009
September 7, 2009
October 12, 2009
November 26, 2009
November 27, 2009
December 25, 2009
January 1, 2010
January 18, 2010
May 31, 2010
HOLIDAY
Independence Day
Labor Day
Columbus Day
Thanksgiving Day
Day after Thanksgiving
Christmas Day
New Year’s Day
Martin Luther King Day
Memorial Day