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This course provides an overview of the clinical research enterprise from a historical and evolutionary perspective, including examples of landmark studies and controversies. Students consider the context in which human clinical study is designed and implemented, with a focus on the components, general principles, and issues in clinical research; types and classification of research studies; formulation of research objectives and outcomes; definition and phases of clinical trial protocols; and the roles and responsibilities of the clinical research team and of study sponsors. The course facilitates the understanding of key medical terminology, in addition to basic knowledge of health, wellness, and disease. The course also emphasizes the development of critical thinking, as well as written, verbal, and interpersonal communication skills, with attention to building competencies needed for student success within an online environment. Students will begin developing a portfolio based on assigned learning activities that include a journal of interaction/interviews with clinical research administrators, an assessment of an organization’s culture, and the identification of management challenges in clinical research.

This course provides basic knowledge of normal and pathophysiological mechanisms of disease, providing the foundation for clinical assessment, decision-making, and management of clinical trials. Attention is given to interpretation of the rationale and procedures underlying the clinical research protocol in order to adequately assess the subject’s response to therapeutic interventions.

This Course Explores The Ethical, Legal, And Regulatory Dimensions Of Human Clinical Research, As Well As The Variety Of Issues That Arise In The Conduct Of Clinical Investigations. Ethical Codes Of Conduct, Regulatory Requirements, And Existing Laws That Govern Clinical Research Are Examined In The Context Of The Historical Events That Contributed To Their Development. Topics Include The Recruitment And Protection Of Human Subjects, Diversity And Vulnerable Populations In Research, Informed Consent, Privacy/confidentiality, The Role Of Independent Review Committees (e.g., Irbs, Iecs), And The Reporting Of Serious Adverse Events (saes). Other Areas Addressed Are Scientific Integrity And Misconduct, International Research, Relationships With Industry, Conflict Of Interest, Intellectual Property, And Publications And Authorship. Social And Ethical Implications Of Genetic Technologies And Research Will Also Be Discussed.

This Course Provides An Introduction To The Basic Elements Of Research Design For Clinical Inquiry. Consideration Is Given To Methods And Goals Of Clinical Research, Formulation Of The Research Objective And Hypothesis, Identification Of Outcome Measures, Issues Of Reliability And Validity, Specification Of The Study Population With Identification Of Exclusion And Inclusion Criteria, Sample-size Calculation, Randomization Procedures, And Documentation Requirements, As Well As Data Collection, Analysis, And Interpretation. Practical Aspects Of Clinical Trial Management Are Presented, Including The Design Of The Case Report Form (crf), Clinical Laboratory Management, Outsourcing, And The Management Of Multicenter Trials. The Influence Of Health Disparities And Cultural Diversity As Factors That Affect The Participation Of Subjects In Clinical Trials Research Is Also Addressed.this Course Provides An Introduction To The Basic Elements Of Research Design For Clinical Inquiry. Consideration Is Given To Methods And Goals Of Clinical Research, Formulation Of The Research Objective And Hypothesis, Identification Of Outcome Measures, Issues Of Reliability And Validity, Specification Of The Study Population With Identification Of Exclusion And Inclusion Criteria, Sample-size Calculation, Randomization Procedures, And Documentation Requirements, As Well As Data Collection, Analysis, And Interpretation. Practical Aspects Of Clinical Trial Management Are Presented, Including The Design Of The Case Report Form (crf), Clinical Laboratory Management, Outsourcing, And The Management Of Multicenter Trials. The Influence Of Health Disparities And Cultural Diversity As Factors That Affect The Participation Of Subjects In Clinical Trials Research Is Also Addressed.

This Course Introduces The Process And Procedures Of Managing And Monitoring A Clinical Trial From Study Initiation To Closeout Of The Clinical Study. The Course Examines Essential Elements Of Good Clinical Practice (gcp) And How Regulations Relate To This Concept And How Gcp Impacts The Practical Elements Of Conducting Clinical Studies. The Basic Tenets Of Gcp, Including Historical Considerations, Compliance, And Recruitment Of Study Participants Are Addressed, With A Focus On Quality Assurance And Data Safety Monitoring Boards (dsmbs), As Well As The Practical Challenges Of Multicenter Or Large-scale Trials; Protocol Management And Amendments; Audits; And Various Considerations For Reporting Requirements. The Course Describes Risk Assessment And Risk Management, In Addition To Adverse-event Reporting And Premature Discontinuation Of Clinical Studies. Official Guidance On Gcp From The U.s. Food And Drug Administration (fda) Will Be Emphasized As Well As Operational Imperatives Of Gcp.

This course addresses the application and interpretation of biostatistics in public health research and practice, including descriptive methodologies, statistical inference and probability, analysis of variance, and simple linear regression. Students are introduced to a statistical computer package such as SPSS.

This Course Examines The Importance Of Information Systems And Information Technology In Increasing Efficiency In The Management Of Clinical Research Data. Consideration Is Given To The Application Of Legal And Ethical Principles With Attention To The Development Of A Data Collection And Management Plan That Promotes Information Archiving And Access As Well As Edit And Query Management. Issues Of Confidentiality And Security Of Information Systems Are Addressed. The Course Also Examines Emerging Technology That Facilitates The Capture And Analysis Of Clinical Study Results, Such As Electronic Data Capture (edc) And Electronic Case Reporting Forms (ecrfs).

This course examines current trends and issues in the pharmaceutical, biotechnology, and medical device industries, with a focus on how the commercial enterprise uses clinical research to bring products to market through the clinical development and regulatory process. Topics include the process by which discoveries become new drugs or medical devices, the preclinical process, and the development of the clinical research plan. Consideration is given to new drug and medical device applications, premarket approvals, and marketing authorizations and postmarketing surveillance, as well as pharmacogenomics, pharmacoepidemiology, recent safety concerns of regulators, globalization, politics of drug pricing and healthcare reimbursement, product life-cycle management, outsourcing of studies to developing countries, patent strategies, and accelerated approval of medications. Case studies representing several therapeutic categories will be analyzed from business, medical, scientific, ethical, regulatory, and biomedical engineering perspectives.

This course provides the foundations for economic evaluation and financial management in clinical research administration, with a focus on the development, analysis, and communication of economic and financial data in the context of clinical research. Special attention is given to health economic issues in the competitive global marketplace, such as resource scarcity and choice in the clinical research environment, cost/benefit considerations in study design and in evaluation of the clinical intervention, opportunity costs, quality of life considerations, valuation of research outcomes, and case studies from the National Institute of Clinical Excellence (NICE). In addition, the course considers financial management aspects of clinical research, including estimating the full cost of a clinical protocol, deciding whether to outsource, calculating direct clinical costs versus research administrative costs and institutional overhead, and developing and negotiating clinical trial budgets and payment terms with sponsors.

This Course Provides An Epidemiological Approach To The Study Of Incidence, Prevalence, And Patterns Of Disease And Injury In Populations And The Application Of This Study To The Control Of Public Health Problems. Key Sources Of Data For Epidemiological Purposes Are Identified, And Principles And Limitations Of Public Health Screening Programs Are Addressed. Students Learn To Calculate Basic Epidemiological Measures And To Draw Appropriate Inferences From Epidemiological Data And Reports. (prerequisite: Pubh 6110 Or Pubh 6125.)

The capstone project concludes the program. This practical, real-world application requires participants to apply the knowledge, skills, and dispositions learned in this program to an actual educational environment. Serving as a consultant, participants will examine a school or district’s curriculum plans against a set of data and make recommendations for improvement and reform.

The optional practicum provides students with an opportunity to apply and integrate the knowledge and skills they have acquired throughout the M.H.A. program and further develop key professional competencies. This experience is in alignment with the students’ academic and professional goals and proceeds under the supervision of faculty. Supervision by an on-site preceptor is a critical component of the practicum. Students begin their 120-hour practicum, participate in an accompanying online seminar course, and continue development of the ePortfolio informed by the practicum. Ongoing monitoring and evaluation is provided by the on-site supervisor and the course instructor.

In this course, learners improve their ability to navigate the virtual campus and become familiar with library, career center, and writing center resources. This course requires the articulation of a professional identity based on master’s-level training in psychology. Learners examine professional roles, organizations, specialization requirements, and codes of ethics in psychology. Learners choose a focused area of study within the field of psychology and identify the educational steps necessary to successfully complete the master’s degree in their chosen specialization. PSY5002 must be taken by master’s learners in their first quarter. Cannot be fulfilled by transfer.

In this course, learners explore lifespan development from infancy through adulthood, including human developmental processes and milestones. Learners evaluate theories and approaches to examining human development and use them to analyze human development processes as they relate to their area of discipline.

In This Course, Learners Analyze Multicultural Perspectives And Factors Such As Ethnicity, Socioeconomic Status, And Gender, And Their Influences On The Ethical Behavior Of Psychology Professionals. Learners Evaluate Multicultural Issues Within The Context Of Different Settings And Learn To Apply Ethical Reasoning Principles And Standards Within Their Profession. Prerequisite(s): Psy5002 Or Psy8002.

This course is an introduction to the general area of mental measurement. Learners examine measuring devices used in the fields of intelligence, interests, personality, and special aptitudes; study techniques for correctly interpreting test scores such as percentiles, standard errors of measurement, validity and reliability indices, and standard scores; and identify professional standards of test development and use. The course includes an analysis of the psychometric procedures used to develop and validate educational and psychological instruments and presents appropriate applications for each type of methodology. MS School Psychology learners must take this course during their second quarter, immediately following PSY5004.

This course focuses on applying parametric statistical procedures to psychological research and the strengths and limitations of conducting quantitative studies. Learners examine sampling issues, experimental design, and concerns of internal validity and study tests of difference between and among groups, and correlations. This course may involve the use of software in the analysis of data sets provided by the instructor. Prerequisite(s): PhD and MS Industrial/Organizational Psychology and MS Leadership Coaching Psychology learners must have completed PSY7610.

This course provides learners with the tools needed to critically read and evaluate research. Learners explore and develop research design skills, and gain an understanding of the scientific methods of inquiry and the ethical considerations of research. This course prepares learners to critically analyze and apply research methodologies, validity, reliability, and other components of scientific research. Prerequisite(s): PhD and MS Industrial/Organizational Psychology and MS Leadership Coaching Psychology learners must have completed PSY7620.

Learners In This Course Examine The Fundamental Procedures For Using Pasw Statistical Software To Transform And Analyze Data Acquired From Psychological Research. Course Topics Include File Structures And Manipulation, Graphical And Descriptive Functions, Variable Transformation And Recoding, And Syntax. Learners Create A Syntax Program In Pasw That Performs Sophisticated Merge And Transformation Operations On Provided Data Files, Including Computing New Variables Derived From The Provided Data.

Learners In This Advanced Course Examine A Variety Of Statistical Analyses, Including Statistical Power And Effect Size In Research Design, Factorial And Repeated Measures Of Analysis Of Variance (anova), Analysis Of Covariance (ancova), Selected Nonparametric Analyses, And Bivariate And Multiple Regression. Learners Are Expected To Have Proficiency In The Use Of Statistical Software Appropriate To Dissertation-level Research. Prerequisite(s): Psy7620. Cannot Be Fulfilled By Transfer.

This Course Focuses On The Theory And Application Of Multivariate Statistics, Including Discriminant Analysis, Factor (components) Analysis, Multiple Analysis Of Variance (manova), And Logistic Regression. Using Spss, Learners Perform And Interpret The Results Of These Analyses. Learners Also Apply Multivariate Analysis, Read And Understand Research Results In Peer-reviewed Psychology Journals, And Utilize Spss To Produce Output Consistent With The Correct Parameters And Assumptions Of Specific Multivariate Procedures. In Addition, Learners Have The Option Of Exploring The Mathematical Aspects Of Multivariate And Inferential Statistics Theory And Application. Prerequisite(s): Psy7625.

This course addresses advanced issues of research design and methodological consideration in the selection and execution of a research proposal. Relationships between problem formulation, hypothesis testing, sampling, data collection, and data analysis are covered in detail. The final project for this course is a research paper that may be applicable to a dissertation proposal. Prerequisite(s): PSY7650. Cannot be fulfilled by transfer.

Learners In This Course Explore The Conceptual And Applied Aspects Of Survey Construction And Administration Processes. Course Topics Include Comparative Study Designs (cross-sections Versus Panels); Sampling Techniques; Data Collection Procedures And Methods (face-to-face, Telephone, Paper, And Internet); Survey Question Design That Accurately Measures Behavior, Attitude, And Personality; Data Processing And Analysis; Results Reporting; Ethics Of Surveys; Causal Inference; And Survey Critiques. Prerequisite(s): Psy7615, Psy7620.

This course provides an examination of the theories, techniques, methods, and processes of program evaluation. Learners synthesize the knowledge and skills gained from prior course work to design, implement, and communicate the results of a simulated program evaluation. Prerequisite(s): PSY7620.

Learners in the MS in Psychology program enroll in this final capstone course after all requirements have been met for the master’s degree. Learners are expected to demonstrate mastery of knowledge, scholarship, and research proficiencies in an identified field of psychology. For MS in Psychology learners only. Prerequisite(s): Completion of all required and elective course work. Cannot be fulfilled by transfer.