ESTABLISHING GRADUATE CERTIFICATES by jolinmilioncherie

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									                                 ESTABLISHING GRADUATE CERTIFICATES
                                      ARIZONA STATE UNIVERSITY
                                       DIVISION OF GRADUATE STUDIES

This form should be used by programs seeking to establish new graduate certificates. All sections should be
completed. Current graduate certificate guidelines may be found at
www.asu.edu/graduate/gapd/GraduateCertificates.htm
The graduate certificate is a programmatic or linked series of courses in a single field or one that crosses disciplinary
boundaries. The graduate certificate facilitates professional growth for people who already hold the baccalaureate
degree and may be free-standing or linked to a degree program. The virtue of the graduate certificate is that it
enables the university to respond to societal needs and promotes university interaction with corporate, industrial, and
professional communities.
Please type.
Contact Name: Renee McLeod, DNSc, APRN, BC, CPNP-PC, Clinical Professor and Director Graduate
Education and Advanced Practice Programs, CONHI
Linda Mottle, MSM-HSA, RN, CCRP, Director Center for Healthcare Innovation and Clinical Trials, Associate
Clinical Professor
Contact Phone: R. McLeod; (602) 496-0855/ Blackberry: (602) 281-5122
                   L. Mottle; 602-496-0684/ 623-570-5772
College: Nursing & Healthcare Innovation
Department/School: Graduate Education and Advanced Practice Programs
Name of proposed Certificate: Graduate Certificate for Clinical Research Management


1. OVERVIEW. Below, please provide a brief overview of the certificate, including the rationale and need for the
program, potential size and nature of the target audience, information on comparable programs (at ASU and/or peer
institutions), how this program would relate to existing programs at ASU, and any additional appropriate information.
Rational and Need for this Certificate Program: This is a 15 credit on-line multi-disciplinary healthcare graduate
certificate utilizing distance education and one initial on site face to face immersion session. The program targets
nurses and healthcare professionals in Arizona and throughout the nation for advanced education as clinical research
professionals in the diversified and complex clinical research industry.
There currently is no option available in the ASU system or in the State of Arizona for certification in the area of
clinical research management. The certificate program is designed to be a stand-alone graduate certificate offered
by CONHI. It will consist of courses designed specifically for this audience and taught by ASU CONHI faculty
members.
The roles of Clinical Research Managers (CRM) are rapidly growing globally and are a career field particularly suited
for nurses as well as for other health care professionals. Nurses have long been involved in clinical research as
study coordinators, principal investigators and data collectors. The medical background, communication skills, critical
thinking skills, and understanding of the clinical environment contribute to their effectiveness in research
management. As importantly, they understand and appreciate the role of patient advocate. The CRM role greatly
expands these responsibilities, demanding extensive expertise in a variety of additional areas.
CRM’s must have an in-depth knowledge and understanding of Federal, state, and local regulations guiding research,
the procedures involved in the development of new drugs, medical devices, biologics, vaccines and other medical
related consumer products, research protocol development, institutional review board requirements and business and
budgetary aspects of the clinical research trials. Nurses and other healthcare professionals working in the role of
CRM are on the cutting edge of research designed to improve health and illness outcomes across the continuum of
care.
They have the opportunity and the responsibility to educate colleagues and research participants of the multifaceted
issues surrounding the conduct of clinical research and development projects. Historically, clinical research
personnel from multiple healthcare disciplines with CRM responsibilities had little opportunity for formal education in
the challenging arena of clinical research management. On-the-job training has been the primary approach for most
individuals in the field. Increased scrutiny on the conduct and ethics of clinical research, the necessity for efficient


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management of clinical trial budgets, and the proliferation of complex, multi-site studies have created an environment
that demands a professional level of education for the individual involved in clinical research management.
Health care professionals from fields outside of nursing may complete the curriculum to obtain a certificate in CRM,
with completion of stated deficiencies. The CRM specialty takes a multidisciplinary approach in providing an
education strong in business and financial practices, ethical and regulatory aspects of research, and overall
management of clinical drug, biological, and medical device trials. It is designed to be flexible and conducive to the
adult learner. All CRM courses are offered online. A 3-4 day on site face to face immersion session at the beginning
of the program will introduce students to faculty, technology requirements and provide opportunities for small group
activities and content delivery.
The student will complete an individual 3 credit hour synthesis of practice/capstone course, which may include
experiences such as serving as a member of a project team working on a drug, biological, device or healthcare
practice development project in industry, academia or government. Other experiences may be arranged based on
the student’s needs. Students meet remaining course requirements through electives chosen from the sciences,
management or other relevant specialty areas.
A wide range of opportunities is open to graduates of the CRM specialty. These include positions within private
industry, such as with pharmaceutical, bio-science, medical device, bio-tech, Federal agencies or federally sponsored
research programs. Managing multi-site projects often involves travel within the United States or in other countries.
The CRM graduate may also choose a more traditional position managing clinical trials conducted within individual
medical facilities, large medical group practices, or specialty clinics that conduct clinical research in addition to their
standard medical practices.
The College of Nursing & Healthcare Innovation 2005-2010 strategic plan notes that College strategies supporting
this Certificate initiative include; “developing new innovative educational programs that would bring national visibility,
strengthen research capabilities, create additional revenue streams, and form Centers of excellence based upon
faculty expertise and the needs of Arizona and the nation”. Early in 2006, College of Nursing Healthcare Innovation
and ASU began developing the University as Entrepreneur initiatives and received the Kauffman Foundation grant for
the development of New Entrepreneurial Initiatives, including starting the new Center for Healthcare Innovation &
Clinical Trials (CHI&T) and the Graduate Certificate for Clinical Research Management. This Certificate is an integral
part of the College’s strategic goals for expanding statewide innovation education programs.



2. ORGANIZING STRUCTURE


A.   Program administration (e.g., executive committee, director, etc.)
Linda Mottle, MSM-HSA, RN, CCRP is a Clinical Associate Professor and has over 30 years experience in the health
and clinical research fields as an administrative manager, nursing clinician, and organizational leader, specializing in
health program and clinical research development. Other faculty in the College of Nursing & Healthcare Innovation
who will be involved in teaching the content of the certificate program includes Drs. Graciela E. Silva, PhD, MPH, MT,
Assistant Professor and Southwest Borderlands Scholar, Kimberly J. Arcoleo, PhD, MPH, Assistant Professor and
Jacalyn A. Askin, PhD, CGFM, Assistant Dean for Finance and Business Support Services. Phyllis Zeno, Center
Coordinator has over 15 years experience in the health sciences development and campus administration arena,
specializing in marketing and program management. Renee McLeod, DNSc, APRN, BC, CPNP, Director, Graduate
Education and Advanced Practice Program, Mary Z. Mays, PhD, Associate Professor, Denise G. Link, DNS,
WHCNP, FNAP, Clinical Associate Professor, Associate Dean for Clinical Practice & Community Partnerships, Carol
Baldwin, PhD, RN, CHTP, AHN-BC, Associate Professor, Southwest Borderlands Scholar, Director, Office of
International Health, Scientific and Educational Affairs, Ruth Brooks, MS, RNC, Manger, Learning Resource Center
are also part of a CONHI faculty planning committee for this certificate program.

B.   Organizing procedures (including how the organizing body will be chosen and function)
This graduate certificate will be administered through the Graduate Education and Advanced Practice Program office
of the College of Nursing & Healthcare Innovation. Faculty named above are experienced research faculty, with
broad perspectives and many specialty research areas as PI’s conducting various type of research studies (basic,
health outcome/process, clinical trials, etc) interested and experienced tenured and clinical faculty in conducting
industry sponsored clinical trials and distance educational programs.

3. ADMISSIONS PROCEDURES AND CRITERIA
A.   Admission criteria



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         ASU Graduate College admission as a non-degree seeking applicant if student is not already a graduate
          student at ASU.
         Must hold a bachelors degree from a regionally accredited institution and have a cumulative junior/senior
          undergraduate GPA of 3.0 or higher in the last two years of course work leading to the bachelors degree.
         All applicants must have completed the following undergraduate 3-credit pre-requisite courses with a grade
          of C or better:
               o    Anatomy and physiology
               o    Medical terminology
               o    Healthcare system overview
               o    Health policy
         A goal statement the outlines the rationale for why the student desires admission and future career goals
          once certificate is completed.
         Resume or curriculum vitae
         Three letters of professional reference
         Unencumbered professional license in the state where the individual Capstone project will be conducted, if
          required (e.g., RN, NP, MSW, PA, and MD).
         Fingerprint clearance for U.S. citizens
         Only completed applications will be reviewed.
B.   Admission decision process
Students who are not already a graduate student at ASU must apply to the Graduate College for admission as a non-
degree graduate student and be admitted to the university before their application can be considered by CONHI, the
Office of Graduate & Advanced Practice Programs. Candidates who meet the above admission criteria may then
apply to The Office of Graduate & Advanced Practice Programs in the CONHI for admission to the Graduate
Certificate in Clinical Research Management as a non-degree seeking student. The Office of Graduate & Advanced
Practice Programs in the CONHI will receive applications from potential students who meet the above admission
requirements. A supplemental admission packet is required for the Certificate in Clinical Research Management.
Completed applications will be reviewed by program faculty and a face to face, web online, or telephone interview will
be conducted with a Program faculty member. Once a student has completed the Graduate College admission and
approval process, the selected and approved students for the next Clinical Research Management Graduate
Certificate admission cycle will then receive an acceptance letter. A waiting list may be instituted, as indicated and
will be based upon acceptance date.
Projected annual admission/enrollment
First year projected enrollment: 25 students
Projected annual enrollment after the first year: 50 students



4. ACADEMIC REQUIREMENTS
A.   Minimum credit hours required for certificate
The certificate is comprised of 5 courses, totaling 15 credits
A minimum of 15 credit hours consisting of 5 courses at 3 credit hours each will be required to complete the Graduate
Certificate for Clinical Research Management. Students who are admitted first through ASU Graduate College as a
non-degree student, and have identified deficiencies in undergraduate preparation for CONHI- Office of Graduate &
Advanced Practice Programs, Clinical Research Management Graduate certificate program will be notified of the
deficiencies. The program director will track those deficiencies and the students who successfully complete all the
deficiency courses and have successfully completed the admission process to the CRM program will be admitted to
the next cohort group . Students must satisfy the deficiencies before starting any CRM courses. The CRM graduate
certificate can be completed in one year. The required courses are taken from new courses offered in the CONHI.
B.   Course delivery mode (e.g., online, face-to-face, off-site)




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This certificate will be on-line distance education and an initial 3-5 day immersion/practicum program at ASU
Downtown Phoenix Campus for orientation to the certificate program. Online lecture modules, online discussion
forums, required readings, synchronous and asynchronous delivery methods (Macromedia Breeze, Web casts,
conference calls, etc.) and self-study assignments will be used. Students are expected to utilize basic informatics
competencies, as outlined in syllabi.
Please describe culminating experience required (e.g., internship, project, research paper, capstone course,
etc.)
The final project for this certificate program will be the Capstone Clinical Research Management Project which is
designed to apply the concepts learned in CRM core courses and present evidence of knowledge in 1) clinical
research principles, ethics, and regulations, 2) clinical trial design and implementation, 3) date entry, management
and statistical analysis, and 4) dissemination of clinical trial results. Students will work individually on a pre-approved
project utilizing clinical research project management methodologies, tools, and processes.
The Capstone course and project will be the last course taken in the certificate program. Students in Plan of Study-I
(part time) will complete their Capstone project during the summer session and Students in Plan of Study II
(accelerated) will complete their Capstone project during the fall semester.
The mechanism for demonstrating this evidence is through a prepared presentation to faculty and classmates online
and one of the following activities:
     1.        the preparation and presentation of a project management plan for designing a clinical trial, preparing a
               detailed research protocol, IRB application, study operations manual, and a data management and
               analysis plan.
     2.        participate as a team management member in a developed clinical trial, chronicling activities and
               completing a written project management evaluation of the clinical trial process and providing evidence
               for suggested quality improvements.
     3.        carry out a written research and analysis project on a clinical research project management topic, area
               of interest, or industry issues or trend that is pre-approved by the faculty.


          For example; Students may work with pre-approved mentors/faculty at other ASU Colleges or Departments,
          such as College of Design-Innovation Space, AZ BioDesign, School of Global Leadership & Management,
          School of Public Affairs. Or, students may achieve their capstone project at pre-approved community
          external research sites, such as Tgen, International Genomics Consortium, healthcare facilities, Sun Health,
          Pivotal, MDS Harris, etc. Mentors/faculty, or research professionals at external capstone sites will provide
          ongoing operational project oversight, while CONHI program faculty will retain academic oversight.
C.   Expected learning outcomes for the program and appropriate methods and measures for evaluation
     Upon completion of the graduate certificate program for Clinical Research Management students shall
     demonstrate the following competencies:
          Evaluate various study designs; recognize their relevance and limitations, and potential threats to validity
          including sources of bias, confounding, and misclassification.
          Formulate a written protocol to address a health services/medical question utilizing sound epidemiological or
          clinical trial designs and principles.
          Articulate the role and responsibilities of clinical research sponsors, investigators, Institutional Review
          Boards, and Data Safety Monitoring Boards and high performance work teams.
          Summarize the OHRP and FDA reporting requirements for clinical trials.
          Formulate a project plan and timeline incorporating project management tools and techniques that includes
          a budget, project tracking and reporting system for a clinical trial synthesizing the concepts of good clinical
          research project management, and current industry trends.
          Identify the challenges and ethical considerations in conducting research with vulnerable populations and
          demonstrate a thorough understanding of the HIPAA Privacy Rule and OHRP human subject regulations.
          Develop a sample clinical research protocol with a completed Institutional Review Board submission packet,
          including a consent form that adheres to the principles for responsible conduct of research.
          Demonstrate how to appropriately estimate the staff, money, and technical resources required for the data
          entry, management and analysis of a multi-site clinical trial




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          Design a data management and analysis plan synthesizing the course content related to forms and
          database design, technology assessment, data quality and data security.
          Synthesize and apply clinical research project management principles, regulations, and best practices by
          preparing a clinical research operations plan that includes; scope of work, enrollment forecasts, deliverable
          timelines, critical path staffing plan, outsourcing requirements, contract negotiations, project budgets, risk
          analysis and contingency plans.
          Analyze the process of clinical trials and formulate evidence-based quality improvement processes.


          Methods of Evaluation;

Each certificate course has an individual final project based upon course competencies. These projects are all
designed to be the foundation for the capstone final project that will demonstrate an integration of program
competencies. Periodic face to face, online web, or telephone discussions with capstone mentors/faculty, CONHI
program faculty and students will occur throughout the capstone semester.

Individual course and capstone pre-approved projects will be presented to classmates and faculty via electronic
submission, web/pod casting and/or teleconferencing. Student interim work status reports, selected research topical
papers and presentations shall be submitted electronically via Blackboard. Mandatory weekly online discussion
forums in all courses are graded. Periodic quizzes, mid-terms, and final examinations via Blackboard in core
courses. Grading rubrics for individual projects, interim reports, and weekly discussion forums will be posted in
Blackboard.

D.   Policies and procedures for tracking students to certificate completion
Students will select a program of study as they enter the certificate program. Plan of Study I is for part time, one
course per semester for a total of 5 semesters to complete the program. Plan of Study II, accelerated, is 2 courses
per semester and can be completed within 3 semesters. Student progression throughout their approved program of
study will be monitored by the CONHI graduate division staff, certificate directors, and program faculty.
E.   Satisfactory student academic progress standards and guidelines (including any time limits for
     completion)
Students will need to obtain a final grade of B in all of the courses in the certificate program per the College of
Nursing & Healthcare Innovation handbook for graduate students.
F.   Proposed policy on students in the certificate program sharing hours used towards the certificate with
     another ASU degree program. (Please note that a maximum of 9 hours taken as a non-degree student at
     ASU, including as a part of a certificate program, may be used towards a future graduate degree at ASU.)
Students in this certificate program may be able to transfer up to 9 hours of this program towards a Master of Science
degree, post-master’s nurse practitioner certificate or doctor of nursing practice degree.
Below, please list all required and elective courses in the appropriate boxes (you may attach additional
pages if necessary).

Please ensure that all new core course proposals have been submitted to the Provost’s office through
ACRES online course proposal submission system. Please note: a minimum of 2/3 of the courses required
for a graduate certificate must be at the 500-level or above.

                                      Core Courses                                  Credit Hours

                      (Prefix & Number)
                                                4 courses are New                          -
                        PROPOSED
                                          Responsible Conduct of
                         HCR XXX                                                          3                                    Comment [f1]: Please assign permanent
                                          Research                                                                             numbers to all of these courses and submit
                                          Clinical Research                                                                    them to ACRES for their approval. Nancy
                         HCR XXX          Management & Regulatory                         3                                    Kiernan in the Provost’s office handles all
                                                                                                                               course approvals. It is a requirement of the
                                          Affairs
                                                                                                                               Provost’s office that course approvals be
                                          Data Management &                                                                    submitted to ACRES simultaneously with the
                         HCR XXX                                                          3                                    program proposal.
                                          Technology Implementation



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                                           Principles of Epidemiology
                    CHP 598/HCR XXX        (approved course- requesting                    3                                  Formatted: Highlight
                                           slight section modifications for
                                           CRM students)




                             Elective Courses (Prefix & Number)                       Credit Hours




                           Culminating Experience (if applicable)                     Credit Hours
                   HCR XXX Capstone Clinical Research Management
                                                                                           3
                                      Project


                                Total required credit hours                               15




5. RESOURCES REQUIRED
A.   Budget projections (including staffing needs)
The college of Nursing & Healthcare Innovation currently has the faculty on staff to teach the courses for this
certificate program.
    An instructional designer/technical assistant is available on site to assist faculty with the on-line distance courses
     for this program. This person will also be assisting other faculty in the college as it moves towards offering more
     on-line distance educational courses at the graduate level. Linda Mottle, Program Director, is very experienced at
     developing and managing multiple Blackboard online courses at post-secondary institutions.
B.   Additional specialized needs (e.g., space, laboratory equipment, library holdings, etc.)
Additional library holdings for clinical research management are being asked for through the new Center for
Healthcare Innovation and Clinical Trials which will be available for Certificate students use.
6. PRIMARY FACULTY PARTICIPANTS. Please list all primary faculty participants for the proposed certificate,
including home unit and title. You may attach additional pages if necessary.
Name                                   Home Unit                              Title
Graciela E. Silva, PhD, MPH, MT        College of Nursing & Healthcare        Assistant Professor of Nursing
                                       Innovation
Linda Mottle, MSM-                     College of Nursing & Healthcare        Clinical Associate Professor; Director,
HSA,RN,CCRP                            Innovation                             Center for Healthcare Innovation &
                                                                              Clinical Trials
Kimberly Arcoleo, PhD, MPH             College of Nursing & Healthcare        Assistant Professor
                                       Innovation



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Jacalyn Askin, PhD, MBA              College of Nursing & Healthcare     Assistant Professor, Director CONHI
                                     Innovation                          Business Services




7. REQUIRED SUPPORTING DOCUMENTS.
   (Please label accordingly, i.e., Appendix or Attachment A, B, etc.)
  Please include the following with your proposal:
     A.   Sample programs of study for students in the proposed program AT END
     B.   Statements of support from all deans and heads of impacted academic units
Please see Appendix A for Sample Program of Study
Please see Appendix B for Statements of Support from Dean Bernadette Melnyk and Director of Graduate and
Advanced Practice Programs, Dr. Renee McLeod.
8. APPROVALS. If the proposal submission involves multiple units, please include letters of support from those
units.


DEPARTMENT CHAIR (PRINT/TYPE)




SIGNATURE                                                                                   DATE




DEAN (PRINT/TYPE)




SIGNATURE                                                                                   DATE




The following section will be completed by DGS following the recommendations of faculty governance
bodies.


UNIVERSITY VICE PROVOST AND DEAN OF GRADUATE STUDIES
SIGNATURE                                                                                   DATE




Submit the completed and signed (chairs, unit deans and if applicable the Campus Provost) proposal to the Office of
Graduate Academic Programs in the Division of Graduate Studies. Mail code: 1003 and electronic copies to
Denise.Campbell@asu.edu
Please note: Proposals for new certificates also require the approval of the Curriculum and Academic Programs
Committee (CAPC), the Academic Senate, and the Office of the Provost before they can be implemented.
Please refer to the Office of the Provost Curriculum Development website to track the status of your proposal
once submitted: www.asu.edu/provost/curriculum (Section titled: Curriculum Actions in Process – 1999 –
Present.)

GF1106G-89




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                                                   Appendix A: Sample Program of Study Student Timelines
                                                    Graduate Certificate for Clinical Research Management


Plan of Study-Course Progression I (Part-time Students - 1 course per semester, 19-20 months
expected completion)

Semester 1: Spring’08                                  Semester 2; Summer I                     Summer II                               Semester 3; Fall ‘08
Principles of                                          Responsible Conduct                      Advise for                          Clinical Research Management
Epidemiology                                              of Research                      MS CRM degree                                  & Regulatory Affairs
                                                                                               process
Semester 4; Spring’09                                 Semester 5; Summer I/II
Data Management &                                      Capstone CRM Project
Technology Implementation



Plan of Study-Course Progression II (Accelerated Students- 2 courses per semester, 12 months
expected completion)
Semester 1: Spring 08                                Semester 2: Summer I                     Summer II                             Semester 3: Fall ‘08
1.Principles of                                     Responsible Conduct                                                           1. CRM & Regulatory Affairs
Epidemiology                                         of Research                                                                 2. Capstone CRM Project
2. Data Mgt & Tech. Implementation
Advise for MS CRM Degree
Admission


Note; Progression of courses in both plans of study is designed to facilitate efficient course offerings with combining both plans of study with minimal duplication for
faculty while adhering to competency progression.




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