Transcript Clinical Research Group - Drexel University College of

Clinical Research Group
Employee Training
And
Management Guide
Welcome Aboard
Welcome to Drexel University College of Medicine and The
Clinical Research Group!
We are delighted to welcome you to the Drexel University College of
Medicine, Clinical Research Group Employee Training & Management Guide. Please
enjoy a walk with us, through our journey of how we started and who we are; what
we do; who our partners are and all available resources that we would like to
share with you, including services of the University that may prove to be
useful for both you and any prospective employees.
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.
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 Clinical Trials 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!
Meet the Office Of Research
Management Team
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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
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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
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Donna J. Walsh, RN, BSN, MS, CIP, CCRC
Chief Operating Officer, Clinical Research Operations
3 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). 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
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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
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Lauren E. May
Senior Coordinator
New College Building, 19118
Phone: (215) 762-8961
Email: [email protected]
Lauren May is the Senior Coordinator. May coordinates the processes required
to develop and foster research activities.
Meet the Office Of Research
Management Team
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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.
Clinical Research Group (CRG) –
An Overview of 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. The 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, the 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 of Who We Are
Our Mission:
Established in 2003, the Clinical Research Group`s 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 of Who We Are
Our Advantages:
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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 (WIRB) for industry-sponsored
clinical trials
Centralized office to foster industry-sponsored research at more than one
research site
Stable patient population
Clinical Research Group (CRG) –
An Overview of What We Do
Our Services:
The CRG is dedicated to assist 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-stop
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 of What We Do
Our Services continued:
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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/Budget:
Priya Sankar
Assistant General Counsel
Associate Director, Contracts and Budget
(215) 255-7845
[email protected]
Stephanie Peterson
Contract Specialist
(215) 255-7805
[email protected]
Legal/Contract/Budget (cont.):
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 III
(215)762-4662
[email protected]
Andrew Francis
Josh Zigmont
Clinical Research Nurse Manager I – HUHSt. Christopher Children`s Hospital
(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 I – HUH-PPP
(215)2 55-7878
[email protected]
Anne Johnson
Research Nurse Coordinator
(215) 255-7877
[email protected]
David Phuong
Clinical Research Nurse Coordinator II
(215) 427-7911
[email protected]
Dr. 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
Website:
www.drexelmed.edu/crg
Clinical Research Group Organizational
Chart
Who we work with – CRG partners
The CRG helps coordinate clinical research operations in the following areas and
more, within DUCOM:
1) Clinical Departments
2) Administrative Departments
3) Institutes
4) Centers
Who we work with – CRG partners
Clinical Departments: DUCOM
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Anesthesiology
Cardiothoracic Surgery
Dermatology
Emergency Medicine
Endocrinology
Hematology/Oncology
Infectious Diseases & HIV
Medicine
Family, Community and Preventive
Medicine
Medicine
Neurology
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Obstetrics and Gynecology
Ophthalmology
Orthopedic Surgery
Otolaryngology
Pathology and Laboratory Medicine
Pediatrics
Psychiatry
Radiation Oncology
Radiologic Sciences
Surgery
Women’s Health
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
Drexel Center for Women’s Health
Who we work with – CRG partners
Office of Regulatory Research Committees ORRC)(IRB/WIRB)
Ensures the protection of human subjects through:
• Responsible for providing provision of protocol review and
approval
• Continuing review of regulatory documentation
• Compliance with federal guidelines
• Proper reporting of study related adverse events and injury
• Human Subject protection through voluntary consent
Location: Office of Regulatory Research Committees
1601 Cherry Street, 3 Parkway Bldg., Suite 10-444
Philadelphia, PA. 19102
Phone Number(s): 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 Areas of Responsibility:
• Assist in non-technical project conceptualization and planning
• Provide general guidelines and interpretation 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 Principal Investigators in the financial closeout of the project
Who we work with – CRG partners
Office of Research Compliance & Administration (ORCA)
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Interpret federal, University and sponsor regulations, policies and guidelines
Prepare invoices and financial reports
Collects cash
Maintain proposal and award 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
Every University Department has an ORCA Program Administrator (PA) who manages the
processes listed above. The list of PA’s by department can be found on the ORCA website
by clicking “Proposal Submission” then “Contacts.”
Located at: 3201 Arch Street, Suite 100, Drexel University Main Campus
Philadelphia, PA, 19104
Phone Number(s): 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.
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The research coordinator will work alongside the pharmacist to develop a budget
for utilizing pharmacy services
Pharmacist is responsible for drug storage and accountability
Mixing and dispensing of a drug is the responsibility of the pharmacist
If subject is to be discharged on study medication, the research pharmacist is
responsible to be the contacted
Located at: Hahnemann Hospital, Basement, North Tower,
Denise Lai Tomako, Pharm. D
Phone Number(s): 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 Number(s): 215-762-7596
Who we work with – CRG partners
Cashier's Office:
This office assists with procurement of subject reimbursement funds.
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Provides petty cash for study related payments
Open Monday-Friday from 9am-5pm
Located at: Hahnemann Hospital , 1st Floor, North Tower (lobby)
Phone Number(s): 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 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
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
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
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
Office of Entrepreneurship and Technology Commercialization
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Works with faculty and staff to identify technologies with commercial potential
Files patents and copyrights to protect technologies
Works with companies, entrepreneurs and investors to license technologies and
bring them to market
Located at: the Laurence A. Baiada Center on Arch Street between 32nd and
33rd, across from Buckley Field
Who we work with – CRG partners
Office of the General Counsel:
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The Office of the General Counsel is the College's lawyers. This office provides
legal services to support the College’s initiatives, missions and operations
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Their services include
– litigation and risk management
– contract negotiation, drafting and review
– legal and regulatory compliance
– 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
Who we work with – CRG partners
Office of the General Counsel:
The Office of the General Counsel provides legal counsel to DUCOM trustees, officers
and employees with regard to legal matters affecting the College.
Note that the OGC 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
Office of the General Counsel:
The Office of the General Counsel provides the following legal services with regard to
clinical research:
• Counsels all research administrative offices (Office of the Vice Dean for Research,
CRG, ORRC and ORCA) in the following:
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Conflicts of interest in research
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Research misconduct and noncompliance
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Protecting the College’s Intellectual Property
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HIPAA and other privacy issues affecting patients and Study subjects
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Any other legal issues affecting research
Who we work with – CRG partners
Office of the General Counsel (legal services cont.):
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Serves as an ex officio member on the IRB
Reviews and negotiates all agreements in connection with research. Thus, you
should not negotiate or sign any research agreements without legal counsel
Located at: 1601 Cherry Street, 3 Parkway Building Suite 10627 Philadelphia, PA 19102
Phone: 215-255-7835 Fax: 215-255-7856
Who we work with – CRG partners
Corporate Compliance and Privacy Office:
What is the Compliance and Privacy Program and why does it exist?
The Corporate Compliance and Privacy Program is a College of Medicine program
designed to ensure regulatory compliance and patient privacy rights as everyone
works to satisfy the College's nonprofit teaching, research and healthcare delivery
missions.
Who we work with – CRG partners
Compliance Hotline :
The following telephone number or web-link may be used to report any improper
conduct:
• College of Medicine/Health Sciences toll free: 866-936-1010
• Web-site reporting: click "Make a Report"
• Every call or web report is kept completely confidential. No information likely to
reveal your identity will be shared with anyone else without your permission. Callers
will be completely protected from retaliation for having made good faith reports
Who we work with – CRG partners
Compliance Hotline continued:
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If you are aware of any conduct - act or omission - which you think violates the
law, College or University policy, rule or regulation, you are urged to report them
to your supervisor, your Department Head, your Dean, or a Vice President, or to
use the hotline
Questions about the University's Code of Conduct or the hotline may be addressed
either to the College of Medicine Chief Compliance and Privacy Officer, Edward
G. Longazel, at [email protected] or to the University's Vice
President and General Counsel, Michael J. Exler, at [email protected]
Who we work with – CRG partners
What are the functions of the
Corporate Compliance and
Privacy Office and staff?
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The staff of the Corporate
Compliance and Privacy Office
manage the day-to-day operations of
the Compliance and Privacy
programs providing the following
services:
Training
Education
Regulatory research
Auditing, monitoring and
investigations
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Coding analysis
Encounter form review
Screening for federal program
exclusion
Electronic Medical Record (EMR)
access approval, auditing and
monitoring
Research protocol reviews for
HIPAA issues
Monitor and manage the Hotline
Report quarterly to the Audit
Committee of the Board of
Directors (PHEC)
Who we work with – CRG partners
The Office of Equality and Diversity (OED):
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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, gender 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
Phone: 215-895-1403
Email: [email protected]
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
Communications and Marketing:
Mission:
The Office of Communications and Marketing raises awareness for Drexel
University College of Medicine through the strategic use of external and
internal communications, fundraising and special events. They are an awardwinning staff dedicated to providing services to their colleagues and the public.
They strive to concentrate their creative energy on the greatest
opportunities, tackling most projects with a team-approach that draws from
the individual strengths of the staff.
Who we work with – CRG partners
Communications and Marketing:
Services rendered:
• Media relations | Media Relations Policy
• Public relations
• Marketing
• Special events | Black Tie White Coat Ball | Golf Outing
• Internal and external communications | Brand Identity Manual
• Web content management | Web Style Guide
• News releases
• Newspager
• Drexel Medcast®
• Drexel Med Monitor
• Strategy for the Future
• 10-Year report
Who we work with – CRG partners
Communications and Marketing:
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Main phone: 215-255-7330
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Media calls: 215-255-7328
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Marketing: 215-255-7333
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Newspager: 215-255-7329
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Website: 215-255-7334
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Events: 215-255-7327
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Fax: 215-255-7301
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 at 866806-0950
• 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: Performance Appraisal
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Communication:
Expresses verbal and written ideas and thoughts clearly and effectively; good
listening and comprehension skills; keeps others adequately informed; uses
appropriate communication methods
Teamwork/Cooperation:
Works effectively with others; establishes and sustains a positive impact on people;
actively contributes to teamwork; balances team and individual responsibilities;
exhibits objectivity and openness to other`s views
Adaptability/Flexibility:
Adapts to changes in the work environment; manages competing demands; accepts
criticism and feedback; adjusts approach or method to best fit the task
Who we work with – CRG partners
DUCOM Human Resources: Performance Appraisal
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Job/Technical Knowledge:
Demonstrates skills and technical competence needed to execute job duties; able to
learn and apply new skills; keeps up with current developments; understands how
job relates to others; uses resources effectively
Initiative:
Seeks solutions to problems both within and beyond area of direct responsibility;
looks for and takes advantage of opportunities; seeks opportunities to increase job
skills and knowledge
Dependability:
Arrives as scheduled, prepared to work; takes responsibility for own actions;
commits to doing the best job possible; keeps commitments
Customer Service:
Understands the service needs of students, patients and/or co-workers and
regularly meets or exceeds them; confirms satisfaction with the customers s/he
serves; continually seeks to enhance/improve the interactions and processes that
influence the satisfaction of those customers; solicits customer feedback to
improve service
Who we work with – CRG partners
DUCOM Human Resources:
Performance Appraisal: Staff Annual Performance Evaluations
To initiate a new staff evaluation, access the online performance management
system by logging in to DrexelOne and following these steps:
• Log in to DrexelOne
• Select the Employees tab
• Select BannerWeb Services for College of Medicine Employees
• Select Employee Information
• Select Performance Management
Who we work with – CRG partners
DUCOM Human Resources:
Performance Appraisal: Staff Annual Performance Evaluations
• Please make sure that pop-ups are enabled. If you select the Performance
Management link and only see a blank screen, use the following instructions to
enable the pop-ups:
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Click on the bar that appears under the URL field on the browser and select Always Allow
Pop-ups from this Site
Select the Performance Management link again
If you have the Google toolbar, select the (1)Pop-ups block icon in the toolbar. Select the
Performance Management link again
The annual Performance Management process can be found on the HR website.
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 HR Policies
and Procedures website
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Code of Conduct
Drug and Alcohol free workplace
Discrimination or Harassment Complaint
Resolution Procedure
Sick Leave
Email Policy
Termination of Employment
Performance Evaluation
Personal Relationships
No Smoking and Tobacco Use
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Weather/Transportation/Emergency
Closing
Confidentiality
Corrective Action
Attendance
Appropriate Business Relationships with
Industry
Appearance
Conflict Of Interest and Commitment
Policy
Grievance/Complaint Resolution
Hours of Work/Overtime
Vacation Leave
Harassment policy
Who we work with – CRG partners
•
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
Our Affiliates
Drexel College Of Medicine (DUCOM):
Regional Medical Campuses:
Alleghany General Hospital
Monmouth Medical Center
Saint Peter’s University Hospital
Over 18 Academic Affiliates, including:
Saint Christopher’s Hospital for Children
Abington Memorial
Friends Hospital
Academic and Research Affiliates
Drexel College Of Medicine (DUCOM)
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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, while 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, even educating more than 500 graduate students. The
College is also the academic partner in 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
Academic and Research Affiliates
Drexel College Of Medicine (DUCOM)
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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 our
Psychiatry Department 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 patient-focused
practice emphasizing quality, innovation and community service, and enhanced
by physician involvement in the research and educational programs
Academic and Research Affiliates
Drexel College Of Medicine (DUCOM)
Since Drexel University College of Medicine does not own its own hospital, it has
partnered with area hospitals and health facilities to achieve its academic and
research missions. The following slides identify DUCOM`s affiliated hospitals.
Academic and Research Affiliates
Friends Hospital
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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
Academic and Research Affiliates
Friends Hospital
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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
Academic and Research Affiliates
Hahnemann University Hospital
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Established in 1885
Located in the heart of Philadelphia
541 licensed beds
Tertiary care academic medical center
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
Academic and Research 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
Academic and Research Affiliates
St. Christopher's Hospital for Children
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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.
Academic and Research 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.
Academic and Research 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
Academic and Research Affiliates
Saint Peter's University Hospital
Specialty services include:
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Cardiac care for adults offering cardiac catheterization and angioplasty
Diabetes care and control center for adults and children
Health center for women
A full service Oncology program
Dorothy B. Hersh regional child protection center
Specialized geriatric services, provided through its Comprehensive
Care Group at Monroe, Adult Medical Center at Monroe and
Margaret McLaughlin McCarrick Care Center in Somerset
Clinical Research Investigator Pipeline
Committee/Forum
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Meetings are open to all Investigators or those interested in
becoming an Investigator
Co-chairs include:
– Dr. Ari Brooks
– Dr. Michael Sherman
– Donna Walsh
Clinical Research Management & Training
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Management of CRG Clinical Research Staff, with dotted line management
to the rest of DUCOM coordinators
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Development and implementation of Clinical Research Staff training
programs
Clinical Research Process Review Groups
• Clinical Research Coordinator Task Force/Committees
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New Employee Orientation/Mentoring – Meets quarterly
Guidance Documents Review Committee – Meets Monthly
Training Action Group (TAG) – Meets weekly
Quality Assurance/ Quality Improvement Program – Meets every other month
Locations and Time schedule are sent via
invitation to volunteer members
Clinical Research Management:
Affiliate/Site Visits
Objectives of the site visits with the staff include:
• To discuss practical trial issues and challenges at site
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To share best clinical practices in support of CRG representative(s) at site
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To establish effective use of new Guidance Documents/guidelines by
reviewing gaps (if any), between what is and what should be
Training & Development
Training at CRG (What is covered):
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Good Clinical Practices (GCP)
Clinical Research Group (CRG) Processes
DUCOM Guidance Documents
Who is trained?
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All DUCOM coordinators and nurse managers
All our affiliate coordinators
4th year medical students (Clinical Research Concepts)
Department of Medicine Residents and fellows
Training & Development
When does training occur?
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During monthly DUCOM CRC scheduled meetings
Self-paced and online
Immediate training on new regulatory updates, outside of established
training dates above
Requests from Departments and Affiliates
As needed
For updated training schedules, please see handout
Schedule is also posted on CRG website
Training & Development
Where is training done?
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New College Building, 19th floor
CRG conference room at 1601 Cherry Street, 3 Parkway Building, Suite 1000
Other available locations announced before training
Approved external conferences
How is training conducted?
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Interactive instructor-led training
On-line, web-based training
Self-paced, CBT’s
Group discussions
Blended learning
Training & Development
Monthly DUCOM Clinical Research Coordinator Meeting:
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This is a forum for all DUCOM clinical research coordinators and nurses,
where discussions on study processes, challenges and issues are discussed
The group also discusses clinical research best practices
They strive to harmonize and standardize all procedures, with the use of
written Guidance Documents, initiated by the Clinical Research Group
This forum meets every second Thursday of the month, from 1-3 pm, in the
Boardroom of the 19th floor, NCB building
Meeting notifications and reminders are sent before each meeting
CRG Clinical Research Training Plan
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New Employee Orientation (NEO)
Collect and maintain Job Descriptions/CVs/Training records for Study
Coordinators
Manage Blackboard Learning Management System (Online Bb Vista
training)
Develop, support and package peer presentations
Provide Continuing Education Contact Hours
Coordinate/Provide DUCOM/Affiliate onsite investigator training
Conduct clinical research on-time training for Attending, Fellows,
Residents, 4th Year Medical Students and one-on-one consultations
Periodically provide clinical research professional certification preparation
sessions to DUCOM/Affiliate staff
Training Compliance
Please note:
1. For training participation to be documented and/or Continuing Education
Contact Hours awarded, both the Bb Vista Online assigned courses, as well
as the scheduled monthly meeting/training sessions, must be completed, and
on time
2. To maintain compliance, staff will receive a notification of training noncompliance, if a training assignment is not completed and/or monthly meeting
not attended
3. A second notification will be sent to the staff’s supervisor/administrator(s), if
the non-compliance is not corrected
4. A final non-compliance notification will be sent to the Office of Research
Dean/Vice Dean
5. Those with dotted line report to CRG will not be signed off on the
performance management appraisal reports to their respective direct
management, if non-compliant
New Employee Orientation:
CRG Mentorship for New Staff
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All new staff will attend a 2-day, CRG-managed, on boarding that starts
immediately after HR orientation and ends with the staff’s department
orientation
The 2-day on boarding will be followed immediately with a 6-week mentorship
program, led by CRG nurses and coordinators
Each nurse/coordinator has been assigned research process guidelines. These
guidelines will help provide mentorship for the new staff
What Comes Next?
•
After the two-day on boarding by CRG, new or transferred staff is handed over
to the respective department's training
•
CRG 6-week mentorship with assigned respective CRG mentors continues for
the department’s period of assignment
Clinical Research Group Guidance
Documents
Clinical Research Guidance Documents:
These are guidelines to standardize the clinical research process
used by staff in the daily conduct of clinical trials. These are located
at the Information for Researchers and Staff page on our website.
Clinical Research Resources
Guides for Grant Applications:
The NIH Resources webpage can further explain the topics below.
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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:
The NIH Resources webpage can further explain the topics below
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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 Do I Start a Clinical Research Study?
The following needs to be completed to initiate a clinical research study:
1.Obtain Institution Approval – DrexelMed must allow you to conduct the study
2.Obtain IRB Approval – You must prepare your study for IRB review and
approval
3.Execute Clinical Research Agreement – You must forward any agreements in
connection with your study to the designated DrexelMed administrative office
4.Establish Budget – You must ensure that the sponsor of the study is providing
sufficient compensation for your study. Although the study budget is usually
incorporated into the clinical research agreement, efforts will be needed to establish
the budget
Clinical Research ResourcesS
How Do I Start a Clinical Research Study?
Clinical research at DrexelMed is managed by administrative offices from both Drexel
and DrexelMed. The above activities are all managed by one or more of the
following offices:
DrexelMed
Drexel
Clinical Research Group (CRG)
Office of Regulatory Research Compliance (ORRC)
Office of the Vice Dean for Research
Office of Research Compliance Administration
(ORCA)
The above processes do not occur in a vacuum. The above offices work together to
ensure all activities are coordinated. For instance, the CRG works with the ORRC to
ensure that contract provisions are consistent with the informed consent that is
approved by the IRB.
Clinical Research Resources
How Do I Start a Clinical Research Study?
In fact, much of the activities above are also used in one single process. For instance,
the forms and documents submitted to ORRC for IRB review are also used by the
Office of the Vice Dean for Research to review and provide Institutional approval.
The activities and processes referenced above can occur at the same time. For
instance, you may submit for IRB approval while the agreement and budget are being
finalized (provided the sponsor permits).
Clinical Research Resources
How Do I Start a Clinical Research Study? Where Do I Go?
DrexelMed has separate processes to complete the below activities depending on how
a clinical research study is funded. Below is a chart to direct you to the correct office
for the below activities:
Industry Funded
IRB Review/Institutional Review
Government /
Private Foundation
Funded
ORRC
ORRC
Contract
CRG
ORCA
Budget
CRG
ORCA
Contracts and Budget Overview
Why Have Contracts for Research?
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Anti-Kickback Safe Harbor
Ensure Compliance
Protect Existing Rights
Intellectual Property
Confidential Information
Allocate Rights and Obligation
Publication Rights
Intellectual Property (Inventions)
Liabilities (Indemnification & Insurance)
Cost (Budget)
Types of Contracts/Legal Issues in Research
Type of Research
Government
Type of Contracts/Issues
Grants/Cooperative Agreements
(DrexelMed is primary grantee)
Subcontracts
(DrexelMed is sub site)
Industry
Sponsor/Supported
DrexelMed Contact Person
Office of Research Compliance
Administration (ORCA)
Shella Waters
215-895-6473
Confidentiality Agreements
Clinical Trial Agreements
Clinical Research Group
Stephanie Peterson
(215) 255-7805
All other legal issues
Priya Sankar, Esq.
(215) 255-7845
Compliance Hotline
866-936-1010 / DrexelMed Website
How Do I Request Contract/Budget Review
•
Industry: Stephanie Peterson
– Provide all documentation (e.g. CTA, budget, protocol)
•
Government: Shella Waters
– Follow ORCA process
Key Terms - Confidentiality Agreements
Defines what is “Confidential Information”
Defines what is not “Confidential Information
Defines how it will be disclosed
Defines who it may be disclosed to
Defines how long it shall be held confidential
Confidentiality Agreements
Protect Yourself! Protect your Colleagues!
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Be careful what you sign
Be careful what you open
Make sure you are aware of your obligations
When in doubt, seek legal counsel
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If you sign, you will be personally liable!
If your PI signs, s/he will be personally liable!
Clinical Trial Agreements
Key Provisions
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Intellectual Property
Confidential Information
Publication
Indemnification
Patient Injury Compensation (if clinical)
Budget
Master Clinical Trial Agreements
• Current Master Clinical Trial Agreements
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Bayer HealthCare Pharmaceuticals, Inc.
Celgene Corporation
Gilead Sciences, Inc.
GlaxoSmithKline (Template)
Johnson & Johnson
Novartis
Sanofi-aventis US
Pfizer, Inc.
Wyeth
• Pending Master Agreements
– Schering-Plough
– Medtronic
– Novo Nordisk
Assessing Budgets
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Determining Standard of Care (SOC) – Labeling the Study
Schematic
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Ensure Compliance
SOC v. Research Procedures
Double-billing
Determining the Cost for Research Services
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Determine who will be providing service
Evaluating Time and Effort in Conducting the Clinical Trial
Pricing hospital services
Ensure Sponsor is responsible for cost of research procedures
Assessing Budget (Effort)
• Common research/clinical tasks:
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Recruiting and advertising
Screening
Review of records
Consenting patients
Explaining or giving directions to a subject
Answering questions by subject
All procedures required by the protocol
Taking a subject’s history
Concomitant medications
Conducting physical examinations
Explaining the activities of the protocol
Setting up and dispensing study drug
Assessing Budgets (Effort)
•
Common Administrative tasks:
– Maintaining research records
– Completing case report forms or other forms required in the protocol
– Communicating with the sponsor via telephone or in person during monitor
visits
– Sending documents or records via e-mail, fax or mail
– Answering queries
– Preparing IRB renewals and amendments
– Reviewing adverse event reports provided by sponsor
– Adverse events reporting
Assessing Budgets
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Other Fees Associated with Research
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Facilities & Administrative (F&A) Costs
Administrative Study Start-up Fee
Internal Review Board (IRB) Fees
Storage Fee
Hospital Pharmacy Fee
Confirming & Negotiating the Budget
– Principal Investigator
– Research Coordinator
– Charlene Middleton
Clinical Research Resources
Research Coordinator Responsibilities
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The primary responsibility of the research coordinator is to facilitate the
daily activities required of clinical research
Reports directly to the Principal Investigator
Ensures required training has been completed by study personnel
Always maintains site in anticipation of FDA audit
Assists PI with feasibility for new trials based on staff and resources
Provides mentorship to new research coordinators
Clinical Research Resources
Research Coordinator Responsibilities cont.
• 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
Clinical Research Resources
Research Coordinator Responsibilities (cont.)
– 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
Study specific responsibilities of the Research Coordinator
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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
– Develop consent form and have PI review for accuracy
– COI Forms completed by all study personnel
– Has required training been completed?
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 the Principal Investigator
•
Providing protection of rights, safety, and welfare of human subjects
– Principal Investigator should educate subject on purpose, risks, benefits
and procedures of the study
– Study subjects should have access to the Principal 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
Principal 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
•
•
Individuals who do not meet University eligibility requirements may be
granted Principal Investigator
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:
• 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
Clinical Research Resources
Process for a Petition to Grant Principal Investigator Status
(cont.)
• 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
• The petition for Principal Investigator status must be specifically approved
on a case-by-case basis
Clinical Research Resources
Regulatory Requirements
IRB submission (full review)
– Project Submission Transmittal Form
– Full Review/Expedited Review Combined Form
– Co-Investigator Form if more than 2 Co-Investigators involved in
study
– Conflict of Interest Form
• Primary Investigator, Sub-Investigator, Study staff
– Research Proposal or NIH Grant (Thesis/Dissertation Proposal)
– Investigator’s Brochure (If Applicable)
– Informed Consent
• Review by Primary Investigator
Clinical Research Resources
Regulatory Requirements (cont.)
– Assent Form
• Pediatric Studies
– Copy of Advertisement (If Applicable)
– Data Collection Instrument (If Applicable)
– Radiation Safety Form (If Applicable)
– Bio-safety Form for Risk Groups 3 & 4 (If Applicable)
– Human Specimens Study Registration Form (All Risk Groups)
Clinical Research Resources
Important addresses and Phone Number(s):
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?t
ab=membershipinformation
Shuttle
http://www.drexel.edu/facilities/ShuttleBrochure.pdf
Clinical Research Resources
When to use Drexel University services (cont.):
Holiday Schedule
MONTH
HOLIDAY
January
New Year’s Day
*possible Day after New Year`s Day
January
Martin Luther King Day
May
Memorial Day
July
Independence Day
MONTH
September
HOLIDAY
Labor Day
November
November
Thanksgiving Day
Day after
Thanksgiving
December
Christmas Day
*possible Day after Christmas Day
Schedule located at: http://www.drexel.edu/HR/benefits/du-holidays.html
Pipeline Presentations
“Investigator
initiated
opportunities”
“Opportunities to
Partner in Research”
“Wyeth Neuroscience
Presentation”
Pharmatech
“Cardio-thrombosis
Pipeline”
“Clinical trials
in the global
market”
“Oncology
opportunities
in clinical
research”
“Patient Reported Outcomes:
as measured in Cystic
Fibrosis”
Each meeting has led to at least one collaborative study
Baxter Bioscience Grants
• Grant Types:
– Research Grants:
– Clinical Research Grants
– Non-Clinical Research Grants
– Education Grants
• Application Types:
– Phase 1: Support Inquiry
– Phase 2: Full Grant Application
Regional Initiatives
Philadelphia
2006
250 Participants
2008
410 Participants
March 28, 2009
Hosted by Drexel University College of Medicine
Sponsors include St. Christopher’s Hospital for
Children
Anticipated: 500+ Participants