1. Clinical Research Group New Employee Orientation

2. 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.

3. 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.

4. 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. Message from the Vice Dean for Research Kenny J. Simansky, Ph.D. Drexel University College Of Medicine, Vice Dean for Research

5. Meet the Office Of Research Management Team Kenny J. Simansky, PhD Vice Dean for Research New College Building, 19116 Phone: (215) 762-8949 Email: Kenny.Simansky@DrexelMed.edu Dr. Kenny Simansky is the Vice Dean for Research. Simansky provides leadership and strategic planning as related to basic and clinical research activities.

6. 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: Noreen.Robertson@DrexelMed.edu 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.

7. 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: Donna.Walsh@DrexelMed.edu 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.

8. Meet the Office Of Research Management Team Richard Huneke, DVM Executive Director of University Laboratory Animal Resources (ULAR) Phone: (215) 762-7970 Email: Richard.Huneke@DrexelMed.edu 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.

9. Meet the Office Of Research Management Team Lauren E. May Senior Coordinator New College Building, 19118 Phone: (215) 762-8961 Email: Lauren.May@DrexelMed.edu Lauren May is the Senior Coordinator. Ms. May coordinates the processes required to develop and foster research activities.

10. Meet the Office Of Research Management Team Danyelle P. Blackwell Executive Assistant New College Building, 19th Floor Phone: (215) 762-8949 Email: Danyelle.Blackwell@DrexelMed.edu Danyelle Blackwell is the Executive Assistant to the Vice Dean for Research.

11. 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!

12. 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.

13. 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.

14. 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

15. 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

16. 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.

17. Meet the Team Clinical Research Group (CRG) Operations: Donna J. Walsh Chief Operating Officer, Clinical Research Operations (215) 255-7803 Donna.Walsh@Drexelmed.edu Theresa M. Piechowski Research Program Administrator (215) 255-7804 Theresa.Piechowski@drexelmed.edu Adam Fuhrer Research Administrative assistant (215) 255-7879 Adam.Fuhrer@drexelmed.edu Legal/Contract: Priya Sankar Assistant General Counsel & Associate Director (215) 255-7845 psankara@drexelmed.edu Stephanie Peterson Contract Specialist (215) 255-7805 speterso@drexelmed.edu Financial/Budget: Anna Wong Senior Financial Analyst (215) 255-7806 Anna.Wong@drexelmed.edu Douglas Livolsi Financial Coordinator (215) 255-7876 Douglas.Livolsi@drexelmed.edu Sally Eells Financial Coordinator (215) 255-7745 Sally.Eelles@drexelmed.edu Research Management – Affiliate Sites: Esther Nkrumah Assistant Director, Clinical Research Management St. Peter’s University Hospital, New Brunswick, NJ (732)745-8600 X5143 Esther.Nkrumah@drexelmed.edu

18. Meet the Team Clinical Research Group (CRG) Clinical: Elizabeth Connor Senior Clinical Research Nurse Coordinator (215) 762-3393 econnor@drexelmed.edu Andrew Francis Clinical Research Nurse Manager 1 – HUH- St. Christopher CH (215) 427-5360; (215)961-8225 Andrew.Francis@drexelmed.edu Marjorie Hepler Clinical Research Nurse Manager 1 – HUH-PPP (215)2 55-7878 mhepler@drexelmed.edu Anne Johnson Research Nurse Coordinator (215) 255-7877 Anne.Johnson@drexelmed.edu David Phuong Clinical Research Nurse Coordinator 11 (215) 427-7911 David.Phuong@drexelmed.edu Clinical continued: Karen Skinner Clinical Research Nurse coordinator 111 (215)762-4662 kskinner@drexelmed.edu Josh Zigmont Data Coordinator (215) 255-7879 Joshua.Zigmont@drexelmed.edu Research Management/Training and Development: Marcellina Oparaoji Associate Director, Clinical Research Management & Training (215) 255-7807 Marcellina.Oparaoji@drexelmed.edu 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

19. Clinical Research Group Organizational Chart

20. 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.

21. 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 patient- focused practice emphasizing quality, innovation and community service, and enhanced by physician involvement in the research and educational programs.

22. 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.

23. 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

24. Our Affiliates Hahnemann University Hospital 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

25. Our Affiliates Hahnemann University Hospital 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.

26. 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.

27. 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.

28. Our Affiliates Saint Peter's University Hospital Incorporated in 1908 Located in New Brunswick, NJ 478 bed teaching hospital offering specialized care from pre-mature babies to geriatrics 10 th 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

29. Our Affiliates Saint Peter's University Hospital Specialty services include: 1.Cardiac care for adults offering cardiac catheterization and angioplasty 2.Diabetes care and control center for adults and children 3.Health center for women 4.A full service Oncology program 5.Dorothy B. Hersh regional child protection center 6.Specialized geriatric services, provided through its Comprehensive Care Group at Monroe, Adult Medical Center at Monroe and Margaret McLaughlin McCarrick Care Center in Somerset.

30. Who we work with – CRG partners Office of Regulatory Research Committees (ORRC)(IRB/WIRB) Ensures the protection of human subjects through: 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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 ex- officio members of this Committee, without vote: Directors of Centers and Institutes, Legal Counsel.

37. 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.

38. 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

39. Who we work with – CRG partners CRG helps coordinate clinical research operations in the following areas and more, within DUCOM: 1)Clinical Departments 2)Administrative Departments 3)Institutes 4)Centers

40. Who we work with – CRG partners Clinical Departments: DUCOM Anesthesiology Cardiothoracic Surgery Dermatology Emergency Medicine Family, Community and Preventive Medicine Medicine Neurology Obstetrics and Gynecology Ophthalmology Orthopaedic Surgery Otolaryngology Pathology and Laboratory Medicine Pediatrics Psychiatry Radiation Oncology Radiologic Sciences Surgery

41. 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!

42. 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.

43. 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.

44. 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.

45. 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.

46. 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.

47. Who we work with – CRG partners DUCOM Centers: 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

48. 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

49. Who we work with – CRG partners Office of Research Technology Commercialization: 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

50. 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

51. 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.

52. Who we work with – CRG partners DUCOM Office of the General Counsel: 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

53. 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

54. 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. Without Regard 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

55. 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.

56. 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' featureAsk HR

57. Clinical Research Resources Guides for Grant Applications: use link to access topics below http://new.drexelmed.edu/Home/Research/ResourcesforResearchers/NIHReso urces.aspx 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

58. Clinical Research Resources Educational Information for Grant Applications: use link for topics below http://new.drexelmed.edu/Home/Research/ResourcesforResearchers/NIHRes ources.aspx Getting Started at NIH Grants Tutorials Grant Writing Tip Sheet Resources for New Investigators Data Sharing Policy Model Organism Sharing Policy

59. Clinical Research Resources How to Start a Trial: Priya please send me your item for here. Thanks

60. 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

61. 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?

62. 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 –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

63. 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

64. 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

65. Clinical Research Resources Principle Investigator Study Specific Responsibilities 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?

66. 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

67. 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 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: 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

68. 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 –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)

69. 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

70. 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

71. 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

72. Clinical Research Resources When to use Drexel University services (cont): Holiday Schedule DAY DATE HOLIDAY Friday July 3, 2009 Independence Day Monday September 7, 2009 Labor Day Monday October 12, 2009 Columbus Day Thursday November 26, 2009 Thanksgiving Day Friday November 27, 2009 Day after Thanksgiving Friday December 25, 2009 Christmas Day Friday January 1, 2010 New Year’s Day Monday January 18, 2010 Martin Luther King Day Monday May 31, 2010 Memorial Day