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Clinical Research Courses - MSHS in Clinical Research Administration

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Set the Standard for Leadership in Clinical Research

The George Washington University (GW) developed the online Clinical Research Administration program to offer students a real-world curriculum that will impact their careers today. Housed in GW’s School of Medicine and Health Sciences, the program combines an applied approach with a strong focus on strategic leadership to provide students with the competencies necessary to become a visionary clinical research leader.

GW’s online Master of Science in Clinical Research Administration is uniquely aligned with the eight published competencies of the Joint Task Force for Clinical Trial Competency, as identified by the Consortium of Academic Programs in Clinical Research (CoAPCR).

The online MSHS program consists of 36 credit hours of clinical research courses and can be completed in 2 years.

  • Core CRA Courses: 18 credit hours
  • Strategic Leadership Courses: 9 credit hours
  • Graduate Research Coursework: 6 credit hours
  • Elective CRA Course: 3 credit hours

Curriculum at a Glance

Core CRA Courses

Credits

CRA 6201

Critical Analysis in Clinical Research

3

CRA 6202

Medicines Development

3

CRA 6203

Partnerships with Human Subjects

3

CRA 6204

The Clinical Research Industry

3

CRA 6209

Quality and Risk Management

3

CRA 6275

Leadership and Change in Clinical Research Administration

3

Strategic Leadership Courses

Credits

HSCI 6223

Topics in Health Care Leadership

3

HSCI 6240

Issues and Trends in Health Systems

3

HSCI 6241

The Health Care Enterprise

3

Graduate Research Courses

Credits

HSCI 6263

Biostatistics for Clinical and Translational Research

3

HSCI 6264

Epidemiology for Clinical and Translational Research

3

Course Descriptions

CORE CRA COURSES (18 credit hours)

CRA 6201: Critical Analysis in Clinical Research (3 credit hours)

Students develop the academic skill sets necessary to succeed in this program in the context of exploring scientific, clinical and regulatory concepts required in medicines development. Students demonstrate their critical analysis skills through literature research, analysis of information from various perspectives, and formulating their own opinions in choosing their ‘defendable positions’, rather than stating the “correct answers”.

Learning Objectives:

  • Synthesize various perspectives from professional, scholarly clinical research and regulatory literature.
  • Analyze the role of critical analysis/evidence-based decision making throughout the process of pharmaceutical new product development.
  • Develop an evidence-based argument in support of a strategy addressing a clinical research challenge.
  • Examine the components of therapeutic product development from discovery through late stage development.

CRA 6202: Medicines Development (3 credit hours)

This course examines the nonclinical, clinical, commercial, regulatory and risk assessment strategies required to develop a clinical development plan for an approvable, marketable new therapeutic and propose life cycle management strategies.

Learning Objectives:

  • Analyze the critical role that nonclinical testing plays in assessing initial safety prior to clinical trials and the types of studies conducted during development to demonstrate long term safety.
  • Evaluate and utilize the strategies attributed to different clinical phases in the clinical development process.
  • Apply appropriate regulatory requirements required to create a regulatory strategy for a particular therapeutic category.
  • Examine the commercial attributes in addition to the clinical characteristics needed to develop an approvable, marketable new investigational therapeutic that demonstrates an adequate benefit/risk profile and commercial viability.

CRA 6203: Partnerships with Human Subjects (3 credit hours)

This course explores regulatory, policy, ethical and practical considerations associated with the engagement, recruitment, retention and interaction with human research subjects.

Learning Objectives:

  • Apply regulatory and ethical considerations to decision-making activities involving recruitment and retention of human subjects in clinical trials as well as the dissemination of clinical trial results to patients by evaluating past and current practices with human subject participants.
  • Evaluate the definition and meaning of partnership, relationship and engagement with patients in the context of clinical research and how these influence societal perceptions of clinical research at large and individual decisions to participate in clinical research activity.  
  • Analyze various methods and their effectiveness for enhancing clinical trial participation and engagement of patient populations within the subject recruitment and retention planning process.

CRA 6204: The Clinical Research Industry (3 credit hours)

The Clinical Research Industry integrates project management principles, decision-making models, cross cultural competency, and interdisciplinary team dynamics to facilitate effective and efficient conduct of clinical trials.

Learning Objectives:

  • Integrate core project management principles and processes for effective clinical trial management.
  • Evaluate how elements of cultural competency, project management and meeting management improve the performance of a culturally diverse, multi-disciplinary team.
  • Assess organizational, cultural and personnel factors that influence successful clinical trial performance.

CRA 6209: Quality and Risk Management (3 credit hours)

This course explores how to manage risk and safety assessments to ensure quality in clinical research.

Learning Objectives:

  • Examine how to manage risk and ensure quality in clinical trial conduct by applying management concepts and training methods.
  • Explore safety risk assessment during clinical development and post marketing for new products.
  • Appraise data quality assurance methods including SOPs to ensure data quality.

CRA 6275: Leadership and Change in Clinical Research Administration (3 credit hours)

Students integrate many of the learnings from the CRA program coursework to create a Masters level proposal intended to address a major area of a change, as well as how to implement the change management proposal, within the clinical research industry. Students initially evaluate and develop strategic alternatives through case studies prior to drafting the Master’s proposal.

Learning Objectives:

  • Explore and assess, and differentiate between the theoretical constructs of change management, and links to complexity theory.
  • Identify and differentiate the critical elements for successful outcomes in organizational and process change.
  • Further develop and demonstrate effective communication skills using a variety of written, verbal and electronic formats.
  • Demonstrate the ability to conceptualize and synthesize information and knowledge as a key component of critical thinking and decision-making.
  • Develop and defend a proposal for initiating a key strategic change initiative within the field of major for graduation.
  • Participate in and further develop interdisciplinary team work with colleagues focused on patient-centered care, evidence-based practice, utilization of informatics and research data, and quality improvement within health systems.

STRATEGIC LEADERSHIP COURSES (9 credit hours)

HSCI 6223: Topics in Health Care Leadership (3 credit hours)

Students examine leadership/leadership change theories in the healthcare industry setting, as well as management and communications strategies, and values in a systems framework. Students develop their own personal leadership philosophies through the various assignments.

Learning Objectives:

  • Discuss the evolution of organizational leadership literature and theories.
  • Apply various leadership theories and their principles in the solution of personal leadership dilemmas and organizational leadership challenges in healthcare settings.
  • Explain relationships that exist between culture and leadership.
  • Identify your own, personal leadership philosophy and style.
  • Relate leadership theory to the health care enterprise.
  • Identify strategies available for developing leadership qualities in others.
  • Explain how leadership relates to learning.

HSCI 6240: Issues and Trends in Health Systems (3 credit hours)

Students examine the major themes on healthcare policies, trends, and issues in the major health systems and research enterprise. Students evaluate the larger contemporary issues, trends, policies, and implications that influence and shape current research and health care practices.

Learning Objectives:

  • Analyze the structure and organization of the US healthcare system.
  • Differentiate and describe the major forms of health care delivery in the US.
  • Evaluate and critique the major legal, ethical, and applied bioethical issues and their impact on health care delivery and the research enterprise.
  • Examine and differentiate conflict of interest issues from personal, organizational, and policy perspectives.
  • Review the structure and roles of the legislative, executive (regulatory), and judiciary branches of the US government and outcomes relevant to health policy development.
  • Analyze the implications of federal, state, and local budget considerations in health policy formulation and implementation.
  • Analyze strategies that can influence health policy, including interest groups, grassroots campaigns, use of research and the media.
  • Compare and contrast current and emerging health policy issues and assess various stakeholder positions on those issues.
  • Given an issue that needs to be addressed within the health care system, formulate a policy analysis within the cost quality access model to influence and improve a health care system.

HSCI 6241: The Health Care Enterprise (3 credit hours)

Students create the essential components of an enterprise strategic business plan. Students develop a mission and vision, strategic initiatives, marketing strategy, and an economic model for sustainability. Through preparing this type of plan, students develop their own strategic planning skill sets for implementing change.

Learning Objectives:

  • Develop a strategic plan that will become part of your degree portfolio.
  • Develop and promote a healthcare enterprise mission and purpose.
  • Apply financial principles in strategic business decision making and evaluation.
  • Apply marketing strategies towards the cultivation of a customer and stakeholder base.
  • Relate organizational theory and practice in order to integrate the various facets of the enterprise into a coherent "organizational enterprise."
  • Utilize information and quality improvement to further develop strategic, analytical and critical thinking skills.
  • Develop strategies for successfully embracing the legal and regulatory influences in the healthcare environment.
  • Develop critical thinking, analytical capabilities, and creative insights that support leadership development in the context of environmental changes affecting the health care enterprise.

GRADUATE RESEARCH COURSES (6 credit hours)

HSCI 6263: Biostatistics for Clinical and Translational Research (3 credit hours)

Students develop the foundation skills in biostatistics to design and analyze a research study. Students examine topic areas such as populations, sample selection, variables, hypothesis formulation, correlation, t-tests, ANOVA, regression, and chi-square analysis. Students examine output from statistical software (SPSS and SAS), practice problems and reviews of scientific literature through assignments such as a research analysis plan.

Learning Objectives:

  • Evaluate data sources and data quality for the purpose of selecting appropriate data that suit specific research questions.
  • Discuss basic principles and the practical importance of key concepts, namely: probability, distribution, measures of central tendency, inductive and deductive reasoning, hypothesis testing, significance level, confidence interval, power, errors of type I and type II, threats to validity, and confidence intervals.
  • Apply numerical, tabular, and graphical descriptive techniques commonly used to characterize and summarize public health data.
  • Transform research objectives into clear, testable statistical hypotheses.
  • Select appropriate statistical methods to be applied in a given research setting and acknowledge the limitations of those methods.
  • Compare two or more groups of data using both parametric and non-parametric statistical methods.
  • Present a research idea in a written proposal.

HSCI 6264: Epidemiology for Clinical and Translational Research (3 credit hours)

Students explore the basic concepts of epidemiology which includes various epidemiological study designs used to examine disease frequency, cause-effect relationships between risk factors and disease states, and effects of bias as examples. Students apply epidemiologic concepts in the context of translational research.

Learning Objectives:

  • Develop a population-based perspective of disease and other health-related events.
  • Calculate and interpret measures of disease frequency, morbidity and mortality.
  • Compare, contrast and describe appropriate applications of the major types of epidemiologic study designs.
  • Examine association and cause-effect relationships between risk factors and specific diseases and conditions.
  • Evaluate strengths and limitations of epidemiologic studies.
  • Assess effects of bias and confounding in published epidemiologic literature.
  • Discuss the impact of epidemiology on public health policy and programs.
  • Evaluate ethical and legal issues in epidemiologic research.
  • Articulate the value of multidisciplinary research in addressing public health problems.
  • Apply epidemiologic concepts in the context of translational research.

ELECTIVE COURSES (3 credit hours)

Discover Excellence in Clinical Research Leadership

To learn more about the online Master’s in Clinical Research Administration, contact an Admissions Advisor today at (844) 386-7323 or request more information.