Clinical Research Group


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  • We currently provide research management services to HUH and Saint Christophers and this year we have engaged with Saint Peter’s University Hospital in a full fledge research center.
  • 3 Master Clinical Trial Agreements and have 6 pending execution.
  • 3 Master Clinical Trial Agreements and have 6 pending execution.
  • We pride ourselves in a program known as the pipeline presentation series. Usually sent out thorough our list serv it is also advertised in DrexelMoniotr. Drexel Medicine and/or its affiliated hospitals function as a site and/or the sponsor in clinical research studies. 
    Who do we serve: the public, industry, and our researchers and staff.   
    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
  • So How can we get some research opportunities: Grants, Industry Sponsored and or you can help me by talking to the Pharmaceutical Representatives and identifying the Clinical Trial Liaison/Scientific Liaison with the company. Clinical is also another wonderful resource tool.
  • So I have told you about the CRG services, opportunities in getting a clinical trial but what about the patients that go into that trial? Without patients, without public awareness in research there would not be any clinical trials. CISCRP is an organization that was formed in Boston and it’s acronym stands for Centers for the Instruction of Research Participation. Annually a program known as AWARE for ALL provides the opportunity for the public to come and learn about clinical research, the role they play and help them become an informed consumer in the area of clinical trials research. Areas of interest are meet the investigator, Meet the Investigator current issues in research, what is an informed consent, specialists from the regional schools attend and discuss research is special areas such as Cardiology, HIV AIDS, Diabetes, Research and Minorities. I would like to welcome you to join us as a volunteer or even for your own input. Last years AWARE for ALL was over 500 people in attendance.
    Who do we serve: the public, industry, and our researchers and staff.
    AWARE for ALL is a non-for profit program that educates the community about clinical research and value of their participation.
    Along with approximately 30 of our partner academic and community organizations will be sponsoring the 4th annual AWARE for ALL program Philadelphia March xxx 10 -2. We would truly appreciate any volunteer time or just to come and be apart of the program.
    The Research Participant
    Why patients are patients not participating in clinical trials.
    (A survey conducted by CenterWatch) revealed that one out of every four volunteers drops out/ and or withdraws from a study after they have begun participation.
    94% of people recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% of the general public state that they have little to no knowledge about the clinical research enterprise and the participation process. (Source: CenterWatch)
    Also started in 2003, The Center for Information and Study on Clinical Research Participation (CISCRP) a national nonprofit organization was founded for the purpose of educating the public, patients, the media, and policy makers in order to promote greater understanding and awareness of the clinical research process.
    AWARE for All, which is a regional initiative (comprised of area academic health centers and community partners) is an educational program free and open to the public for the purpose of providing information to help people make informed decisions about clinical research participation
    Philadelphia held the first AWARE for all in 2006 at the University of the Sciences with a little over 225 in attendance. The 2nd Annual AWARE for All – Philadelphia, was held on April 12, 2008, was held at Thomas Jefferson University Hospital with over 440 of the public in attendance.
    I am proud to announce the 3rd Annual AWARE for All – Philadelphia, Clinical Research Education Day on Saturday, March 28, 2009 being held in collaboration now with Abington Memorial Hospital, Children’s Hospital of Philadelphia, Doylestown Hospital, Drexel University College of Medicine, Temple University, Thomas Jefferson University, University of Pennsylvania, Saint Peter’s University Hospital and Saint Christopher’s Hospital for Children. Many physicians from the sponsored schools will be presenting, from Saint Christopher’s will be Dr. Jill Foster. I would like to open the invitation and hope you can attend.
  • Clinical Research Group

    1. 1. Clinical Research Group Employee Training And Management Guide
    2. 2. 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.
    3. 3. 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.
    4. 4. 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.
    5. 5. 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
    6. 6. 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!  
    7. 7. Meet the Office Of Research Management Team • Kenny J. Simansky, PhD Vice Dean for Research New College Building, 19116 Phone: (215) 762-8949 Email: Dr. Kenny Simansky is the Vice Dean for Research. Simansky provides leadership and strategic planning as related to basic and clinical research activities.
    8. 8. 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: 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.
    9. 9. Meet the Office Of Research Management Team • 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: 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.
    10. 10. Meet the Office Of Research Management Team • Richard Huneke, DVM Executive Director of University Laboratory Animal Resources (ULAR) Phone: (215) 762-7970 Email: 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.
    11. 11. Meet the Office Of Research Management Team • Lauren E. May Senior Coordinator New College Building, 19118 Phone: (215) 762-8961 Email: Lauren May is the Senior Coordinator.  May coordinates the processes required to develop and foster research activities.
    12. 12. Meet the Office Of Research Management Team • Danyelle P. Blackwell Executive Assistant New College Building, 19th Floor Phone: (215) 762-8949 Email: Danyelle Blackwell is the Executive Assistant to the Vice Dean for Research.
    13. 13. 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.
    14. 14. 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.
    15. 15. Clinical Research Group (CRG) – An Overview of 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 (WIRB) for industry-sponsored clinical trials • Centralized office to foster industry-sponsored research at more than one research site  • Stable patient population
    16. 16. 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
    17. 17. Clinical Research Group (CRG) – An Overview of 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
    18. 18. Meet the Team Clinical Research Group (CRG) Operations: Donna J. Walsh Chief Operating Officer, Clinical Research Operations (215) 255-7803 Theresa M. Piechowski Research Program Administrator (215) 255-7804 Adam Fuhrer Research Administrative Assistant (215) 255-7879 Legal/Contract/Budget: Priya Sankar Assistant General Counsel Associate Director, Contracts and Budget (215) 255-7845 Stephanie Peterson Contract Specialist (215) 255-7805 Legal/Contract/Budget (cont.): Anna Wong Senior Financial Analyst (215) 255-7806 Douglas Livolsi Financial Coordinator (215) 255-7876 Sally Eells Financial Coordinator (215) 255-7745 Research Management – Affiliate Sites: Esther Nkrumah Assistant Director, Clinical Research Management St. Peter’s University Hospital, New Brunswick, NJ (732)745-8600 X5143
    19. 19. Meet the Team Clinical Research Group (CRG) Clinical: Elizabeth Connor Senior Clinical Research Nurse Coordinator (215) 762-3393 Andrew Francis Clinical Research Nurse Manager I – HUH- St. Christopher Children`s Hospital (215) 427-5360; (215)961-8225 Marjorie Hepler Clinical Research Nurse Manager I – HUH-PPP (215)2 55-7878 Anne Johnson Research Nurse Coordinator (215) 255-7877 David Phuong Clinical Research Nurse Coordinator II (215) 427-7911 Clinical continued: Karen Skinner Clinical Research Nurse Coordinator III (215)762-4662 Josh Zigmont Data Coordinator (215) 255-7879 Research Management/Training and Development: Dr. Marcellina Oparaoji Associate Director, Clinical Research Management & Training (215) 255-7807 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:
    20. 20. Clinical Research Group Organizational Chart
    21. 21. 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
    22. 22. Who we work with – CRG partners Clinical Departments: DUCOM • Anesthesiology • Cardiothoracic Surgery • Dermatology • Emergency Medicine • Endocrinology • Hematology/Oncology • Infectious Diseases & HIV Medicine • Family, Community and Preventive Medicine • Medicine • Neurology • Obstetrics and Gynecology • Ophthalmology • Orthopedic Surgery • Otolaryngology • Pathology and Laboratory Medicine • Pediatrics • Psychiatry • Radiation Oncology • Radiologic Sciences • Surgery • Women’s Health
    23. 23. 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 • Drexel Center for Women’s Health
    24. 24. 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
    25. 25. 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
    26. 26. Who we work with – CRG partners Office of Research Compliance & Administration (ORCA) (cont.) • 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
    27. 27. 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 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
    28. 28. 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
    29. 29. Who we work with – CRG partners Cashier's Office: This office assists 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 Number(s): 215-762-8480
    30. 30. 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.
    31. 31. 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.
    32. 32. 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
    33. 33. 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.
    34. 34. 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.
    35. 35. 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.
    36. 36. 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.
    37. 37. 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.
    38. 38. Who we work with – CRG partners Office of Entrepreneurship and Technology Commercialization • 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
    39. 39. Who we work with – CRG partners Office of the General Counsel: • 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 • 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
    40. 40. 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.
    41. 41. 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: – Conflicts of interest in research – Research misconduct and noncompliance – Protecting the College’s Intellectual Property – HIPAA and other privacy issues affecting patients and Study subjects – Any other legal issues affecting research
    42. 42. Who we work with – CRG partners Office of the General Counsel (legal services cont.): • 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  
    43. 43. 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.
    44. 44. 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
    45. 45. Who we work with – CRG partners Compliance Hotline continued: • 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 or to the University's Vice President and General Counsel, Michael J. Exler, at
    46. 46. Who we work with – CRG partners What are the functions of the Corporate Compliance and Privacy Office and staff? 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 • 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)
    47. 47. 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, 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
    48. 48. 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:
    49. 49. 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!
    50. 50. 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 award- winning 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.
    51. 51. 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
    52. 52. Who we work with – CRG partners Communications and Marketing: • Main phone: 215-255-7330 • Media calls: 215-255-7328 • Marketing: 215-255-7333 • Newspager: 215-255-7329 • Website: 215-255-7334 • Events: 215-255-7327 • Fax: 215-255-7301
    53. 53. 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 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
    54. 54. Who we work with – CRG partners DUCOM Human Resources: Performance Appraisal • 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
    55. 55. Who we work with – CRG partners DUCOM Human Resources: Performance Appraisal • 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
    56. 56. 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
    57. 57. 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: – 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.
    58. 58. Who we work with – CRG partners
    59. 59. 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
    60. 60. 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 Our Affiliates
    61. 61. Academic and Research 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, 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
    62. 62. Academic and Research 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 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
    63. 63. 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.
    64. 64. Academic and Research 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
    65. 65. Academic and Research 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
    66. 66. Academic and Research Affiliates Hahnemann University Hospital  • 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
    67. 67. Academic and Research 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
    68. 68. Academic and Research 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. 
    69. 69. 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.
    70. 70. Academic and Research 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 • 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
    71. 71. Academic and Research Affiliates Saint Peter's University Hospital Specialty services include: • 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
    72. 72. Clinical Research Investigator Pipeline Committee/Forum • Meetings are open to all Investigators or those interested in becoming an Investigator • Co-chairs include: – Dr. Ari Brooks – Dr. Michael Sherman – Donna Walsh
    73. 73. Clinical Research Management & Training • Management of CRG Clinical Research Staff, with dotted line management to the rest of DUCOM coordinators • Development and implementation of Clinical Research Staff training programs
    74. 74. Clinical Research Process Review Groups • Clinical Research Coordinator Task Force/Committees – 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
    75. 75. Clinical Research Management: Affiliate/Site Visits Objectives of the site visits with the staff include: • To discuss practical trial issues and challenges at site • To share best clinical practices in support of CRG representative(s) at site • To establish effective use of new Guidance Documents/guidelines by reviewing gaps (if any), between what is and what should be
    76. 76. Training & Development Training at CRG (What is covered): • Good Clinical Practices (GCP) • Clinical Research Group (CRG) Processes • DUCOM Guidance Documents Who is trained? • All DUCOM coordinators and nurse managers • All our affiliate coordinators • 4th year medical students (Clinical Research Concepts) • Department of Medicine Residents and fellows
    77. 77. Training & Development When does training occur? • 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
    78. 78. Training & Development Where is training done? • 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? • Interactive instructor-led training • On-line, web-based training • Self-paced, CBT’s • Group discussions • Blended learning
    79. 79. Training & Development Monthly DUCOM Clinical Research Coordinator Meeting: • 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
    80. 80. CRG Clinical Research Training Plan • 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 
    81. 81. 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 non- compliance, 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
    82. 82. New Employee Orientation: CRG Mentorship for New Staff • 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
    83. 83. 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
    84. 84. 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.
    85. 85. Clinical Research Resources Guides for Grant Applications: The NIH Resources webpage can further explain the topics below. • 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
    86. 86. Clinical Research Resources Educational Information for Grant Applications: The NIH Resources webpage can further explain the topics below • Getting Started at NIH • Grants Tutorials • Grant Writing Tip Sheet • Resources for New Investigators • Data Sharing Policy • Model Organism Sharing Policy
    87. 87. 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
    88. 88. 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: 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. 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)
    89. 89. 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).
    90. 90. 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 Government / Private Foundation Funded IRB Review/Institutional Review ORRC ORRC Contract CRG ORCA Budget CRG ORCA
    91. 91. Contracts and Budget Overview Why Have Contracts for Research? • 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)
    92. 92. Types of Contracts/Legal Issues in Research Type of Research Type of Contracts/Issues DrexelMed Contact Person Government Grants/Cooperative Agreements (DrexelMed is primary grantee) Subcontracts (DrexelMed is sub site) Office of Research Compliance Administration (ORCA) Shella Waters 215-895-6473 Industry Sponsor/Supported 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
    93. 93. How Do I Request Contract/Budget Review • Industry: Stephanie Peterson – Provide all documentation (e.g. CTA, budget, protocol) • Government: Shella Waters – Follow ORCA process
    94. 94. 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
    95. 95. Confidentiality Agreements Protect Yourself! Protect your Colleagues! • Be careful what you sign • Be careful what you open • Make sure you are aware of your obligations • When in doubt, seek legal counsel • If you sign, you will be personally liable! • If your PI signs, s/he will be personally liable!
    96. 96. Clinical Trial Agreements Key Provisions • Intellectual Property • Confidential Information • Publication • Indemnification • Patient Injury Compensation (if clinical) • Budget
    97. 97. Master Clinical Trial Agreements • Current Master Clinical Trial Agreements – 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
    98. 98. Assessing Budgets • Determining Standard of Care (SOC) – Labeling the Study Schematic - Ensure Compliance - SOC v. Research Procedures - Double-billing • Determining the Cost for Research Services – 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
    99. 99. Assessing Budget (Effort) • Common research/clinical tasks: – 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
    100. 100. • 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 (Effort)
    101. 101. • Other Fees Associated with Research    – 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 Assessing Budgets
    102. 102. Clinical Research Resources Research Coordinator Responsibilities • 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
    103. 103. 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
    104. 104. 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
    105. 105. 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 – Develop consent form and have PI review for accuracy – COI Forms completed by all study personnel – Has required training been completed?
    106. 106. 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
    107. 107. 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
    108. 108. Clinical Research Resources Principal 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?
    109. 109. 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
    110. 110. 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
    111. 111. 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
    112. 112. 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
    113. 113. 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)
    114. 114. 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
    115. 115. Clinical Research Resources When to use DUCOM services: Human Resources: Comptroller`s Office
    116. 116. Clinical Research Resources When to use Drexel University services: Gym tab=membershipinformation Shuttle
    117. 117. Clinical Research Resources When to use Drexel University services (cont.): Holiday Schedule MONTH HOLIDAY MONTH HOLIDAY January New Year’s Day September Labor Day *possible Day after New Year`s Day January Martin Luther King Day November Thanksgiving Day May Memorial Day November Day after Thanksgiving July Independence Day December Christmas Day *possible Day after Christmas Day Schedule located at:
    118. 118. Pipeline Presentations “Wyeth Neuroscience Presentation” “Cardio-thrombosis Pipeline” “Opportunities to Partner in Research” “Patient Reported Outcomes: as measured in Cystic Fibrosis” Each meeting has led to at least one collaborative study Pharmatech “Clinical trials in the global market” “Oncology opportunities in clinical research” “Investigator initiated opportunities”
    119. 119. 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
    120. 120. Regional Initiatives 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 Philadelphia