Department of Allied Health - Certificate in Clinical Research

z-2018-2019 Program - New - Major or Certificate

completed

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General Catalog Information
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  • Select Program below.

    Shared Cores are available in Acalog for shared information in program curriculum.

  • Type of Program *

  • **Read before you begin**

    1. Please turn on the help text before starting this proposal by clicking on the icon in the top right corner of the heading. Items with help text indicating format should be typed in the exact format as the help text (excluding the quote marks).
    2. Once all required fields have been filled in, click in the upper left corner, to launch proposal.
    3. Once you have launched the proposal form you can then begin editing imported fields, adding justifications, etc. All changes from that point will be tracked. Optionally, you may also attach syllabi or any additional supporting documents by clicking on the Proposal Toolbox icon.  . Please be aware that forms submitted without appropriate justifications will be returned to the proposer without consideration.
  • Status*
  • Identify Purpose of Proposal*
  • College*
  • Department*
    (e.g. Department, Division, School)
  • Program Level*
  • Does this proposal require TEC approval?*
  • Degree Level*
  • If Certificate, select appropriate option
  • Program Type*
  • Degree Type*
  • Title of Proposed Degree Program*
    Certificate in Clinical Research
    Certificate in Clinical Research
  • EEO Status
  • Name of Program Director*
    Olu Ekundayo
    Olu Ekundayo
  • Intended Date of Implementation*
    Summer 2018
    Summer 2018
  • Anticipated Date for Granting First Degrees*
    Summer 2019
    Summer 2019
  • Evaluation Criteria

  • All actions in the approval of new programs for public institutions are subject to a stipulation regarding the program’s ability to attain specified goals that have been established by the institution and approved by the Council on Postsecondary Education (the Council). At the conclusion of an appropriate period of time, the program’s performance shall be reviewed by Council staff following criteria established in the Council’s Academic Programs Policy.

  • Centrality to the Institution’s Mission and Consistency with State’s Goals

  • A program will adhere to the role and scope of the institution as set forth in its mission statement and as complemented by the institution’s strategic plan.

  • List the objectives of the proposed program*
    • Provide students with a strong foundational knowledge base in the ever-growing field of clinical research
    • Prepare students for a wide-variety of clinical research positions at academic institutions, biopharmaceutical companies and contract research organizations
    • Provide students with a sought-after, multidisciplinary skill-set for clinical study conduct in local, regional and global settings
    These objectives should deal with the specific institutional and societal needs that this program will address.
  • Explain how the proposed program relates to the institutional mission and academic plan*

    By offering a much-needed skill set that will prepare graduates for positions at clinical research and academic centers in Kentucky and surrounding states, the Certification in Clinical Research program promotes Northern Kentucky University’s mission to empower graduates to have fulfilling careers while contributing to the economic vitality of the region. The objectives specifically address the College of Health Professions’ goal to address the critical regional need for healthcare professionals. Furthermore, this program supports the mission of the Institute for Health Innovation at Northern Kentucky University.

     

  • Explain how the proposed program addresses the state’s postsecondary education strategic agenda*

    The program also supports the Kentucky Council on Postsecondary Education’s mission to strengthen Kentucky’s workforce and economy.  The Master’s level Certification in Clinical Research program objectives address CPE’s 2016-2021 Strategic Agenda Objective 9 “Improve the career readiness and employability of postsecondary education graduates.” Specifically, the involvement of CTI Clinical Trial and Consulting in the development of the core curricular courses and the certification program in collaboration with NKU supports Strategy 9.4 “Promote regular, meaningful employer involvement in the development and evaluation of postsecondary programs that are relevant to their business/industry.” and Strategy 9.5 “Identify current and emerging workforce demands, entrepreneurial business opportunities and stackable credentials that can lead to additional education/training.”

  • Explain how the proposed program furthers the statewide implementation plan*

    The program also supports the Kentucky Council on Postsecondary Education’s mission to strengthen Kentucky’s workforce and economy.  The Master’s level Certification in Clinical Research program objectives address CPE’s 2016-2021 Strategic Agenda Objective 9: “Improve the career readiness and employability of postsecondary education graduates.”

    Specifically, the involvement of CTI Clinical Trial and Consulting in the development of the core curricular courses and the certification program in collaboration with NKU supports the following State prost secondary strategic agenda items:

    1). Strategy 9.4 “Promote regular, meaningful employer involvement in the development and evaluation of postsecondary programs that are relevant to their business/industry.” and

    2). Strategy 9.5 “Identify current and emerging workforce demands, entrepreneurial business opportunities and stackable credentials that can lead to additional education/training.”

  • Program Quality and Student Success

  • The curriculum should be structured to meet the stated objectives and student learning outcomes of the program.

  • Student learning outcomes of the program
    <p style="margin-left:.5in">Graduates completing the curriculum for the Certification in Clinical Research program will be able to demonstrate each of the following learning objectives:</p> <ul> <li>Explain the basic processes required for effective clinical study design, implementation and analysis</li> <li>Apply sound ethical principles to the conduct of human clinical research and to recognize potential ethical challenges</li> <li>Describe the relationship between current International Conference on Harmonisation &ndash; Good Clinical Practice (ICH-GCP) guidelines and effective study conduct and documentation of trial objectives</li> <li> <p style="margin-left:.5in">Graduates completing the curriculum for the Certification in Clinical Research program will be able to demonstrate each of the following learning objectives:</p> </li> <li>Explain the basic processes required for effective clinical study design, implementation and analysis</li> <li>Apply sound ethical principles to the conduct of human clinical research and to recognize potential ethical challenges</li> <li>Describe the relationship between current International Conference on Harmonisation &ndash; Good Clinical Practice (ICH-GCP) guidelines and effective study conduct and documentation of trial objectives</li> </ul>
    List all student learning outcomes for the program.
  • Explain how the curriculum achieves the program-level student learning outcomes*

    The overall curriculum fulfils one of the three eligibility criteria for certification as a Clinical Research Professional (CRP), Category 3. (Hold an Undergraduate or Graduate Certificate in “Clinical Research” with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university). http://www.socra.org/certification/ccrp-certification-exam/candidate-eligibility/

    Describe the relationship between the overall curriculum or the major curricular components and the program objectives.
  • Highlight any distinctive qualities of this proposed program*

    Offering a Certificate Program allows for a prospective student to gain expertise in the clinical research field in one to two years. This allows both professionals and recent graduates to enhance their skillset and knowledge in a specific area that is attractive to the CRO and biopharmaceutical industry.

    The NKU Clinical Research Certificate program will be focused around 3 core courses, which have been designed by professionals in the CRO industry. These three courses have been carefully designed to provide the necessary preparation for a successful career in clinical research by a broad audience – ranging from recent graduates to those who have worked in the professional field for many years and are looking to focus their expertise in a niche area. The three core courses will ensure students gain an appreciation for the regulations and ethics surrounding clinical research, as well as for the entire clinical research process, starting at the conception of a clinical trial, and through the implementation and completion of a trial.

    In addition to the 3 core courses, 3 additional courses have been carefully selected to facilitate research methodologies in the health care industry, (MHI 650 Evidenced Based Health Care Methods), as well as interprofessional relationship and management skills (COM 603 Business Communications, MGT 670 Negotiations and Conflict Resolution + Applied (MGT 671 (1 credit)). This specific focus allows this program to differ substantially from other clinical research certificate programs, which may have a stronger focus on therapeutics or clinical aspects, while neglecting a major part of the job description for many positions in the clinical research industry. Having these courses will prepare students to effectively communicate in a professional setting and how to manage conflict and negotiations. According to articles in the Business and Professional Communication Quarterly (Ortiz, L.A., et.al, March 10, 2016) and the National Federation of Independent Business (September 30, 2016), employers are struggling to find candidates with these highly sought after “soft skills”, specifically oral and written communication, teamwork and organization.  The National Association of Colleges and Employers (NACE) Job Outlook 2016 report also cites verbal communication as the most important candidate skill/quality with teamwork and decision making/problem solving rated in the top three. As the CRO industry is built on a client-facing platform, while being able to simultaneously manage an internal team, these skills are paramount in having a successful career.

  • Will this program replace or enhance any existing program(s) or track(s) within an existing program?*
  • If yes, please specify. Include the projected faculty/ student in major ratio
  • Is there a specialized accrediting agency related to this program?*
  • If yes, identify the agency
    Society of Clinical Research Associates (SOCRA)
    Society of Clinical Research Associates (SOCRA)
  • Do you plan to seek accreditation?*
  • If yes, explain your plans for accreditation. If no, explain your rationale for not seeking accreditation*

    One reason this certificate was developed to prepare those who complete it to be prepared to take the certification as a Clinical Research Professional (must have 2 years exp.)

  • Attach the SACS Faculty Roster Form in the Proposal Toolbox . Faculty resources shall be demonstrated to be adequate and appropriate for the proposed program. The number of faculty should meet external standards where appropriate. The qualifications of faculty will support the objectives and curriculum of the proposed program.

  • Access to the qualitative and quantitative library resources must be appropriate for the proposed program and should meet recognized standards for study at a particular level or in a particular field where such standards are available. Adequacy of electronic access, library facilities, and human resources to service the proposed program in terms of students and faculty will be considered. Physical facilities and instructional equipment must be adequate to support a high quality program. The proposal must address the availability of classroom, laboratory, and office space as well as any equipment needs.

  • Describe the library resources available to support this program. You may attach any documentation provided to SACS*

    Three of the courses in the program are existing NKU courses, which already have ample resources in the library. The three new courses specific to clinical trials will only utilize online sources that are free to students (most are government sites). Students will purchase 1 textbook which is costs $71.99 as an ebook or $89.95 as a paperback. It would be ideal if the library purchased this book for the reserves stack.

  • Describe the physical facilities and instructional equipment available to support this program*

    The current physical facilities and instructional equipment are adequate to meet the needs of this program even with growth.

  • Clearly state the admission, retention, and completion standards designed to encourage high quality*

    All students will be required to meet NKU graduate admission standards and have an undergraduate GPA of 3.0.

    The 3 clinical trial specific courses will require students to achieve a B as the minimum grade for successful completion of the course.

    In the 3 existing NKU courses students will be required to meet the individual course standard.

    The certificate coordinator will monitor student progress and track retention/completion over time.

    An Advisory Board will be implemented to assure that the certificate is meeting industry needs. All faculty will be screened before hire to ensure they meet expectation in regards to content expertise etc.

  • Clearly state the degree completion requirements for the program*

    The three (3) clinical trial specific courses will require students to achieve a B as the minimum grade for successful completion of the course. In the 3 existing NKU courses students will be required to meet the individual course standard. All six courses must be successfully completed to earn the certificate.

  • Provide the following information for the program and for each concentration (some categories may not apply to all programs):

  • Total number of hours required for degree (incuding General Education credits)*
    18
    18
  • Number of hours in degree program core*
    18
    18
  • Number of hours in concentration*
    0
    0
  • Number of hours in guided electives*
    0
    0
  • Number of hours in free electives*
    0
    0
  • Delivery Method*
  • Alternative Delivery Mode Formats (Check all that apply)*
    Does the program use alternative learning formats (e.g. distance learning, technology-enhanced instruction, evening/weekend classes, accelerated courses)?
  • Describe how the proposed program will articulate with related programs in the state*

    This certificate does not intend to directly articulate with any educational institution. All courses were intentionally selected as NKU courses. This was intentional to make sure it ran smoothly with the 1st cohort. Despite this reality, a student may transfer up to 1/3 of the courses for the certificate from another institution. We did anticipate that individuals from other institutions with degrees in biology, chemistry, psychology, health professions and others might be interested in the certificate and we will market to those groups. CHP did collaborate with Clinical Trials & Consulting (CTI) to develop this certificate. In the future we plan to make the certificate fully online. At that point we may develop articulations with other institutions.

    It should describe the extent to which student transfer has been explored and coordinated with other institutions.

  • Attach all draft articulation agreements related to this proposed program in the Proposal Toolbox .

  • Provide Catalog Program Description:*

    This certificate is designed for those individuals interested in working in the field of Clinical Trials Research. Areas of study include clinical study management and associated components such as biopharmaceutical development, regulatory requirements, components of start-up of clinical studies, regulatory documentation, safety reporting, data and statistical consideration, management of clinical supplies, and monitoring of clinical studies.  Coursework related to the development of soft-skills in leadership and communication necessary to effectively conduct clinical studies is also included. 

  • List courses under the appropriate curricular headings, byThen follow the directions below to create proposed curriculum in Proposal.

    Prospective Curriculum Field

    Step 1

    There are two options to add courses for proposed changes: "Add Course" and "Import Course." For courses that already are in the catalog, click on "Import Course" and find the courses needed. For new classes that are in the Curriculog Approval Process click on "Add Course"-- a box will open asking you for the Prefix, Course Number and Course Title.

    Step 2

    Click on  "View Curriculum Schema." Click on "Add Core" which will be the header for your course groups of the program. After creating the different sections you can proceed to assign courses in each header by clicking on "Add Courses" this will bring up the list of courses available from Step 1. Select the courses you wish to add and reorder as needed by dragging courses. For removing courses click on the .

    Commonly used headers: Degree Requirements, Core Courses, Electives.

  • Prospective Curriculum*
  • Describe planned alternative methods of program delivery*
    The 3 existing NKU courses will be online. The new courses will be face to face initially but the plan is to make them online
    The 3 existing NKU courses will be online. The new courses will be face to face initially but the plan is to make them online

  • Complete the following only if the proposed program is an advanced practice doctorate:

  • Describe how the doctorate builds upon the reputation and resources of the existing master’s degree program in the field
  • Explain the impact of the proposed program on undergraduate education at the institution
    Within the explanation, note specifically if new undergraduate courses in the field will be needed.
  • List and discuss the nature and appropriateness of available clinical sites
    Supply letters of commitment from each clinical site that specifies the number of students to be accommodated and identifies other academic programs that also use the facilities.

  • Supply letters of commitment from each clinical site that specifies the number of students to be accommodated and identifies other academic programs that also use the facilities.

  • Program Demand/Unnecessary Duplication

  • Proposed programs must respond to the needs of the academy and to larger economic and social environments. Thus, the institution must demonstrate demand for the proposed program. All proposed programs must address student demand. Programs must also address either employer demand or academic disciplinary needs.

    Student Demand:

  • Clearly describe all evidence of student demand*

    According to the US Bureau of Labor Statistics, the healthcare sector is expected to grow faster and add more jobs than any other sector over the next decade. In 2016, the healthcare industry accounted for 15.8 million jobs, growing by over 400,000 jobs per year. With the aging population and continued advances in medical care, the biotechnology and pharmaceutical industries will only continue to grow. The US Bureau of Labor Statistics reported that employment in the biotech and pharmaceutical industries will increase at a faster rate than average over the next 15 years. This will result in excess jobs and demands for employees with scientific backgrounds and training in clinical research and informatics.

    The changing landscape of drug development has spurred a change in the industry, where biotechnology and pharmaceutical companies have begun to target niche operators that offer highly specialized research and development services. The emergence of these Contract Research Services, or Contract Research Organizations (CROs) has grown rapidly over the last 15 years. The pharmaceutical and biotechnology industries have continued to outsource, as they push for cost reductions and improved research efficiencies to drive their products to production. According to Nice Insight’s 2015 Pharmaceutical and Biotechnology outsourcing survey, over half of companies that outsource to CROs expected to reduce project length and costs.

    The CRO market is expected to grow to $45.2 billion by 2022, a 67% increase from the $27.0 billion it was estimated to be in 2014.  Specifically, the United States is the largest CRO market, accounting for $17 billion of the market, and is expected to grow 5.4% annually through 2022. Services by CROs include the operations related to clinical trial management, but also post-marketing surveillance, pre-clinical trials, and other various services. A study at Tufts University School of Medicine (Boston, MA) reported a 7% average annual growth rate in the number of jobs at CROs between 2000 and 2010 (double that reported in the previous decade). In addition as cited in the American Pharmaceutical Review (2016), Persistence Market Research predicts the global biopharmaceuticals market, which was valued at $162 billion in 2014, to grow at a compound annual growth rate of 9.4% to reach $278 billion in 2020, a 71% increase overall from 2014.

     

     

     

    Typically in the form of surveys of potential students and/or enrollments in related programs at the institution.
  • Provide evidence of student demand at the regional, state, and national levels*

    Locally, Northern Kentucky and Southwest Ohio house corporate headquarters for several CROs, including CTI Clinical Trial and Consulting (Covington, KY) and MedPace (Cincinnati, OH), and Camargo Pharmaceutical Services, LCC (Cincinnati, OH). All of these companies are actively recruiting future employees with experience and/or training in the clinical research industry as they continue to grow. Outside of the CRO industry, other local organizations hire professionals and routinely have job postings for individuals focused in clinical research. These include hospitals and clinical centers such as Cincinnati Children’s, University of Cincinnati, The Christ Hospital, Wright State University, Wright Patterson Air Force Base, St. Elizabeth Hospital, TriHealth, various Phase I units, and other smaller institutions with a research branch. Pharmaceutical and biotechnology companies of varying sizes also have a local presence or are headquartered locally, including companies such as Ethicon (Cincinnati, OH) and Teva Pharmaceuticals (Cincinnati, OH), as well as other smaller biotechnology companies such as Bexion Pharmaceuticals (Covington, KY) and Aerpio Pharmaceuticals (Blue Ash, OH).

     

  • Identify the applicant pool and how they will be reached*

    The initial applicant pool will be recruited from current NKU students from majors such biology, chemistry, psychology & health sciences. Students will also be recruited form our partner on the certificate Clinical Trials & Consulting (CTI). Within the next 1-1.5 years , we plan to move this program to either hybrid or online format to broaden our student base to the entire Tristate region. Initial contacts will be made internally thought flyers and electronic media.

  • Describe the student recruitment and selection process*

    The current application process for Graduate students entering NKU will be used for the certificate. The Department of Allied Health in collaboration with the Colleges of Business & Informatics will develop a process for identifying those who will be admitted to the program.

  • Identify the primary feeders for the program*

    The primary feeders will be NKU, Clinical Trials & Consulting (CTI) and other institutions engaged in clinical research.

  • Provide any evidence of a projected net increase in total student enrollments to the campus as a result of the proposed program*

    We anticipate 24 students in year one and 24-48 in year two.

  • Complete the Projected Student Demand Estimate for the first five years of the program [link to resource document to be provided] and attach in Proposal Toolbox .

    Employer Demand:

  • Clearly describe evidence of employer demand*

    The US Bureau of Labor Statistics reported that employment in the biotech and pharmaceutical industries will increase at a faster rate than average over the next 15 years. This will result in excess jobs and demands for employees with scientific backgrounds and training in clinical research and informatics.

    Such evidence may include employer surveys, current labor market analyses, and future human resources projections. Where appropriate, evidence should demonstrate employers’ preferences for graduates of the proposed program over persons having alternative existing credentials and employers’ willingness to pay higher salaries to graduates of the proposed program.
  • Describe the types of jobs available for graduates, average wages for these jobs, and the number of anticipated openings for each type of jobs at the regional, state, and national levels*

    Types of jobs available for graduates

    Org Type (Major Employers)

    Average Wages

    Number of anticipated openings

    Clinical Trial/Research Manager

    Cincinnati Children's Hospital (181)

    The Christ Hospital Health Network (50)

    Medpace (26)

    Alkermes, Inc. (12)

    Mercy Health (12)

    $45K -  $90K

    Regional: (50 miles) – 384 posted as at 12/18/2017 https://www.indeed.com/jobs?q=clinical+research+manager&l=Cincinnati%2C+OH&radius=50

    state

    national

    Clinical Research Coordinator

    Cincinnati Children's Hospital (48)

    Medpace (19)

    The Christ Hospital Health Network (19)

    University Of Cincinnati (9)

    UC Health (6)

    $46,182 (($35K-$62K)

    Regional: (50 miles of Cincinnati) – 144 posted as of 12/18/2017 https://www.indeed.com/jobs?q=Clinical+Research+Coordinator&l=Cincinnati%2C+OH&radius=50

    Clinical Research Associate

    Cincinnati Children's Hospital (116)

    University Of Cincinnati (40)

    Medpace (22)

    Alkermes, Inc. (16)

    The Christ Hospital Health Network (10)

    $62,769  ($41K-$90K)

    Regional: (50 miles) – 311 posted as at 12/18/2017 https://www.indeed.com/jobs?q=Clinical+Research+Associate&l=Cincinnati%2C+OH&radius=50  

    state

    national

    Clinical Project Manager

    Cincinnati Children's Hospital (109)

    Medpace (28)

    Mercy Health (15)

    CTI Clinical Trial Services, Inc (7)

    UC Health (7)

    $82,234 ($2K-$122K)

    Regional: (50 miles) – 275 posted as at 12/18/2017 https://www.indeed.com/jobs?q=clinical+project+manager&l=Cincinnati%2C+OH&radius=50

    state

    national
     

  • Academic Disciplinary Needs:

  • Clearly describe all evidence justifying a new program based on changes in the academic discipline or other academic reasons*

    All health care professions demand that practice be based on sound evidence. Clinical based research (improving patient outcomes, medical device, pharmaceutical etc.) has increased exponentially. The demand for individuals skilled in clinical research management/coordination has increased as a result of this trend. NKU does not currently have a program preparing students for this field.

  • If the proposed program is an advanced practice doctorate explain the new practice or licensure requirements in the profession and/or requirements by specialized accrediting agencies that necessitate a new doctoral program

  • Similar programs:

  • A new program may serve the same potential student population, the proposed program must be sufficiently different from existing programs in the state or access to existing programs must be sufficiently limited to warrant initiation of a new program.

    Identify similar programs in other Southern Regional Education Board (SREB) states and in the nation.

    If similar programs exist in Kentucky,

  • Does the proposed program differ from existing programs?*
  • If yes, please explain

    Due to the increases in growth of the industry state previously (67-71% increase in 2020 from 2014) and the subsequent expansion of careers, employers are searching for prospects with relevant knowledge of the industry Recently, many clinical research programs have emerged at various universities allowing students to obtain professional degrees specific to clinical research.

    Locally, the University of Cincinnati offers a Master of Science (MS) in Drug Development as well as one in Clinical and Translational Research. UC also offers a Certificate in Clinical Research through UC Blue Ash. Specifically, the MS in Drug Development program, which launched in 2004 with 14 students, now enrolls more than 100 students each year and their 11th group graduated in 2016. In total, 80 students have graduated with their MS in Drug Development, and 150 students have taken one or more classes.

    Other universities offering programs include Ohio State which offers a Master of Science in Applied Clinical and Preclinical Research, University of Kentucky which offers a certificate in Clinical and Translational Science, and the University of Louisville which offers a Master of Science and a certificate in Clinical Investigation Sciences. Several other programs within the tristate area are offered at Kent State University, Case Western University, Indiana University, amongst others. Refer to Table 1 for a listing with additional details on programs which are based within the Indiana, Ohio and Kentucky areas.

     

    As referenced above, many of these programs are Master’s level. Having a certificate level program allows for students to move swiftly through the coursework. Only one other institution in the local area – UC Blue Ash – has a certificate program in Clinical Research, thereby monopolizing any local student looking to obtain further education via a certificate in this area. Regionally, both the University of Kentucky and the University of Louisville offer graduate certificate programs in Clinical Research, ranging from 12-15 credit hours for completion and are both offered in-person, without an online option.

    We plan to utilize a blended learning approach to attract students, a feature that none of the local or regional programs utilize. This blended format allows working professionals who are in the program a little more flexibility with regard to travel and in-class work. Following the first year of successful implementation of the certificate program, we plan to continue to move towards more online offerings to attract students who wish to attend remotely. In addition, the proposed program for NKU differs from these local and regional certificate options by having a specific focus on management and interpersonal and soft skills required by the industry.

    An additional promising feature of this program is utilizing working CRO professionals as the course developers and instructors. Current staff working at CTI Clinical Trials and Consulting (a local CRO) in collaboration with NKU faculty will be both developing and teaching the courses which make up the core curriculum. This will allow for students to have access to professional resources in the field through which they can gain a professional network, be presented with real-life examples of what is occurring currently in the industry, and also will afford them potential job recommendations.

  • Does the proposed program serve a different student population from existing programs?*
    (i.e., students in a different geographic area)
  • If yes, please explain

    Not directly unless students are seeking the soft skill courses our program offers.

  • Is access to existing programs limited?*
  • If yes, please explain

    Existing programs are limited to some students because of the requirement or delivery format.

    We plan to utilize a blended learning approach to attract students, a feature that none of the local or regional programs utilize. This blended format allows working professionals who are in the program a little more flexibility with regard to travel and in-class work. Following the first year of successful implementation of the certificate program, we plan to continue to move towards more on line offerings to attract students who wish to attend remotely. In addition, the proposed program for NKU differs from these local and regional certificate options by having a specific focus on the leadership, interpersonal and soft skills required by the industry.

  • Is there excess demand for existing similar programs?*
  • If yes, please explain

    Demand for these positions is expected to exceed the supply due to the rapid growth of Contract Research organizations.

  • Will there be collaboration between the proposed program and existing programs?*
  • If yes, please explain the collaborative arrangements with existing programs

    The program will be supported by and will support the Health Informatics and Communications Programs in the College of Informatics, as well as the Management Program in the College of Business which will all offer required courses in the program. These courses are MHI 650 Evidence Based Health Care Methods, COM 603 Business Communications, and MGT 670 Negotiations and Conflict Resolution + Applied  (MGT 671 – I credit). The deans of all of these colleges have provided confirmation of support for the program.

     

    The future medical school would potentially be supported by this certification program as there are certification programs in Clinical Research at Indiana University and Case Western University, as well as a Certificate in Clinical and Translational Science at University of Kentucky which are offered only to post-graduates with M.D.s or similar degrees. This will enhance the ability of medical professionals to serve as Principal Investigators on clinical trials.

  • If no, please explain why there is no proposed collaboration with existing programs
  • Cost and Funding of the Proposed Program

  • The resource requirements and planned sources of funding of the proposed program must be detailed in order to assess the adequacy of the resources to support a quality program. This assessment is to ensure that the program will be efficient in its resource utilization and to assess the impact of this proposed program on the institution’s overall need for funds.

  • Will this program require additional resources?*
  • If yes, provide a brief summary of additional resources that will be needed to implement this program over the next five years

    One adjunct faculty per course offered is required each semester. It is not anticipated that we would hire a fulltime faculty member. All course would be coverd by adjuncts or current faculty. If the program grew exponentially, there may be the need for a 0.5 FTE staff member.

  • Will this program impact existing programs and/or organizational units within your institution?*
  • If yes, please describe the impact

    3 courses from outside the College of Health Professions are being offered. Two from Informatics and one from Business, These Colleges were involved in the development of this certificate and have indicated they have the capacity.

  • Provide adequate documentation to demonstrate sufficient return on investment to the state to offset new costs and justify approval for the proposed program.

    If this is an advanced practice doctorate, provide assurance that funding for the program will not impair funding of any existing program at any other public university.

  • Cost/Funding Explanation

  • Complete the Funding Sources, by year of program and Breakdown of Budget Expenses/Requirements tables for the first five years of the proposed program [link to resource document to be provided] and provide an explanation of how the institution will sustain funding needs, attach document in Proposal Toolbox. *The total funding and expenses in the table should be the same, or explain sources(s) of additional funding for the proposed program.

  • Program Review and Assessment
  • Describe program evaluation procedures for the proposed program*

    The Department of Allied Health will create a Certificate Program Evaluation committee who will develop a systematic plan for evaluation of the certificate program. This committee will be the oversight body to ensure program quality and to ensure program evaluation occurs in a timely and systematic nature. An Advisory Board for the certificate program will also be developed to ensure that the program meets the needs of external partners etc.

     

    These procedures may include evaluation of courses and faculty by students, administrators, and departmental personnel as appropriate. Program review procedures shall include standards and guidelines for the assessment of student outcomes implied by the program objectives and consistent with the institutional mission.

  • For each assessment method, please provide direct indicators of achievement of program-level student learning outcomes and frequency of data collection:

  • Which components will be evaluated?*

    Completion Rate

    1) 80% of students will successfully complete the certificate on time (150% - 9 semesters)

    Program satisfaction survey

    1) 85% of students completing the certificate indicate that they are satisfied or very satisfied with the certificate.

    2) 85% of students competing the certificate indicate they would recommend the certificate.

    Enrollment

    1) Program will achieve 85% of target enrollment (85% of 24 = 20)

    Certification

    1) 75 % of graduates will achieve certification within 3 years of completion of certificate.

  • When will the components be evaluated?*

    Completion Rate - will be assessed after first cohort finishes last class

    Program satisfaction - will be assessed after first cohort finishes last class

    Enrollment - each semester

    Certification - 3 years after 1st cohort completed all courses

  • When will the data be collected?*

    Completion Rate - student progression through program will be tracked continuously

    Program satisfaction - will be collected after first cohort finishes last class; records will be ongoing

    Enrollment - collected each semester; records will be ongoing

    Certification - collected 3 years after first cohort completed all courses; records will be ongoing

  • How will the data be collected?*

    Completion Rate -initially internally by department review of student academic record. Long term when numbers increase will work with IR to track

    Program satisfaction - initially internally by department vai a Qualtrics survey

    Enrollment - initially internally by department review of class rosters. Long term when numbers increase will work with IR to track.

    Certification - communication with graduates initially; may be able to obtain from certification agency (TBD)

  • What will be the benchmarks and/or targets to be achieved?*

    Completion Rate

    1) 80% of students will successfully complete the certificate on time (150% - 9 semesters)

    Program satisfaction survey

    1) 85% of students completing the certificate indicate that they are satisfied or very satisfied with the certificate.

    2) 85% of students competing the certificate indicate they would recommend the certifcate.

    Enrollment

    1) Program will achieve 85% of target enrollment (85% of 24 = 20)

    Certification

    1) 75 % of graduates will achieve certification within 3 years of completion of certificate.

  • What individuals or groups will be responsible for data collection?*
    Certificate Program Evaluation committee or their designee.
    Certificate Program Evaluation committee or their designee.
  • How will the data and findings be shared with faculty?*
    At program meetings and Advisory Board meetings
    At program meetings and Advisory Board meetings
  • How will the data be used for making programmatic improvements?*

    Data will be reviewed for areas of strength and opportunities for growth. Recommendations will be made and changes implemented in the courses etc. as needed.

  •  

  • What are the measures of teaching effectiveness?*

    Current NKU guidelines for the evaluation of teaching will be used. This includes a review of student course ratings. CHP ID one major item to track over time for all faculty: The instructor was effective.

    It is also expected that 85% of faculty in the certificate program are at or above the college mean for teaching effectveness on course ratings.

  • What efforts to improve teaching effectiveness will be pursued based on these measures?*

    All new faculty will be assigned a FT NKU faculty mentor. Faculty who do not meet benchmarks after one course will meet with the chair and mentor to develop a plan for improvement.

  • What are the plans to evaluate students’ post-graduate success?*

    students will be surveyed one year after completion to ascertain

    1) Did they obtain a position in clinical trials research

    2) How did they feel the certificate program prepared them for their position

    3) Do they  have plans to obtain certification? if yes when?

  • Attachment List
  • Attached
  • Attached*
  • Attached
  • Attached
  • Attached
VPUAA Processes
Next
  • CIP Code
    51.0719
    51.0719
  • BOR Approval Date
    Not Required for Certificates
    Not Required for Certificates
  • CPE Final Approval Date
    1/26/2018
    1/26/2018
  • CPE ID
    14157
    14157

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