Speciality Requirements Student must complete 30 credit hours

Course Code	Course Name	Credit Hours	Prerequests
7750501	Introduction to Clinical Epidemiology Research	2
This course provides a basis for an understanding of the concepts and methodological skills necessary for designing and interpreting observational studies. These include validity (random error, bias and confounding), measures of disease occurrence and impact, measures of association, reliability and generalizability, causal inference, and critically reviewing evidence. The objectives for this course are for participants to: 1) Apply epidemiological study designs and methods to answer questions of clinical relevance. 2) Evaluate quality of scientific literature, assess available evidence, generation of evidence and levels of evidence 3) Apply principles of observational study design, including variants of the case-control design, use of matching, sample size and power calculations. 5) Select and develop appropriate exposure and outcome measurement procedures, including questionnaires, interviews, collection of biological specimens, physical measurements, and quality control and assurance methods. 6) Identify major sources of bias in observational studies and ways to identify their likely direction, magnitude and nature of their threat to causal inference. 7) Understand the concept of prognosis, design of prognostic studies, bias in prognostic studies, and the development of clinical prediction rules. 8) Understand the principles of diagnostic testing and applying them in clinical research and practice, interpretation of multiple tests.
7750502	Designing Clinical Research	2
In this problem-based course, each student is expected to build a clinical research proposal in his/her field of interest. Each week, students are asked to present specific parts of their protocols to facilitate the discussion of successive stages in study design. This course is an introduction to the process of clinical research, defined broadly as patient-oriented, translational, epidemiologic, comparative effectiveness, behavioral, outcomes, or health services research (i.e., any research that has individual human beings or groups of human beings as its unit of observation). Students are exposed to overarching concepts and essential vocabulary for designing and interpreting clinical research. This is primarily accomplished by instructing students in the creation of a research protocol that is intended to address a relevant research question in their specific area of interest. The objectives for this course are for participants to: 1) acquire skills for designing and interpreting clinical research; 2) produce a complete clinical research protocol, including background, sampling, measurements, and data analysis; and 3) help others in the class to develop these skills and protocols.
7750503	Social Determinants and Behavioral Aspects of Clinical Research	2
The health and well-being of individual patients and society as a whole may be more related to social and behavioral factors than to purely medical factors. This course will promote an understanding of the design, implementation, analysis, and interpretation of studies of social and behavioral determinants of disease, interactions between these determinants, and medical treatment, or interventions to improve health problems. The objectives for this course are: 1) Identify the meaning and measurement of race/ethnicity, socioeconomic status and other core concepts; 2) Understand a multi-level and longitudinal framework for influences on health in diverse populations; and 3) Describe the essential role of community engagement when conducting research with diverse populations.
7750504	Quality and Safety in Healthcare	2
This course begins with an overview of health services research (HSR). Subsequent classes will focus on either important topics within HSR or methods used in HSR; conceptualization of healthcare quality and safety; quality of care measurements; improvement science; and introductions to survey research and qualitative research. Understand how to assess quality of care for a medical condition The objectives for this course are for participants to: 1) Describe key elements of published quality assessment and improvement studies; 2) Understand how to develop a workable quality improvement and evaluation plan Safety; 3) Recognize the extent of problems in patient safety in medical care; 4) Describe the role of various systems and factors in creating safety and in causing errors and adverse events; 5) Discuss problems and issues in measuring and reporting safety; 6) Demonstrate knowledge of the basics of conducting an incident investigation and disclosing an adverse event; 7) Design solutions to improve patient safety; and 8) Understand the ethical, legal, and regulatory implications related to patient safety
7750505	Biostatistics for Clinical Investigators	2
This course begins with an overview of descriptive statistics and provides students with the tools to perform univariate analyses using parametric and non-parametric methods for paired and unpaired designs. Emphasis is placed on choosing appropriate tests, evaluating assumptions for the tests, understanding the limitations of statistical tests, and appropriate interpretation of test results. The objectives for this course are for participants to: 1) Describe the role biostatistics serves in the discipline of public health; 2) Differentiate among different sampling methods and discuss their strengths and limitations; 3) Describe the strengths and limitations of designed experiments and observational studies; 4) Distinguish among different measurement scales, choose the appropriate descriptive and inferential statistical methods based on these distinctions, and interpret the results; 5) Determine preferred methodological alternatives to commonly used statistical methods when assumptions are not met; 6) Apply basic concepts of probability, random variation, and commonly used statistical probability
7750507	Ethical Issues of Clinical Research	2
This course introduces the fundamental ethical principles of autonomy, beneficence, nonmaleficence, and justice and applies these principles to clinical research involving human subjects. The use of unproven therapies, the use of placebos, the consent process, institutional review board submission and review processes, conflict of interests, and the costs of clinical research are covered. The objectives for this course are for participants to: 1) Compare tools for ethical analysis used in clinical practice; 2) Identify and critically discuss ethical issues in clinical research; and 3) Prepare an analysis of a case study presenting an ethical dilemma in clinical research
7750508	Statistical Computing in Clinical Research	2
Performing clinical research in the current era requires the use of computers and a high level of competency in the use of database, spreadsheet, and statistical software programs. This course is designed to introduce you to these programs, prepare you for subsequent courses in the Training in Clinical Research Program curriculum, and, in particular, teach you the skills you will need to start exploring your own clinical research data using statistical software. The specific objectives are to provide students with an introduction to 1) The roles of spreadsheets, relational databases, and statistical software packages, such as SPSS, in analyzing clinical research data; 2) Using SPSS, for importing, cleaning, managing, and describing and analyzing clinical research data; and 3) Applying these skills to exploring and analyzing data from your own research project.
7750509	Publishing and Presenting Clinical Research	2
Instruction in preparing abstracts for scientific conferences; the essential components of a research manuscript (Introduction, Methods, Results, Discussion); and navigating the submission and revision aspects of the peer-reviewed process. This course is designed to introduce students to the core knowledge and skills necessary to: 1) Prepare research abstracts for competitive submission to scientific meetings as well as for full-length research manuscripts; 2) Create concise, effective, and engaging oral and poster research presentations for scientific conferences; 3) Develop the critical content and structure of the introduction, methods, results, and discussion sections of a research manuscript; 4) Present research data effectively in table and graphic form in order to highlight the most important findings of their research; 5) Navigate the manuscript submission and review process, both internally with co-authors and externally with a journal; and 6) Develop strategies for writing about science for public audiences via press releases, opinion/editorial pieces, and other perspectives approaches
7750510	Translating Research Evidence into Clinical Practice	2
This course surveys a range of translational tools at the health care system level that you can use to promote the adoption of evidence-based medicine by providers and delivery systems. Learn strategies for change in the broader context of sociological theories of organizational behavior and policy implementation. This course is designed to introduce students to the core knowledge and skills necessary to: 1) Explain the origins, processes and application of evidence-based healthcare practice in relation to the students area of practice; 2) Demonstrate how to develop a clinical question for the implementation of the evidence-based healthcare practice process; 3) Discriminate between the different types and levels of evidence and describe the strengths and deficiencies of each; 4) Use skills in the construction of search strategies and literature searching; 5) Critically appraise research articles; 6) Articulate the methods used to combine evidence to produce recommendations for clinical practice, 7) Understand the meaning of evidence-based medicine and the importance of critical appraisal skills; 8) Be able to identify different study designs; 9) Be able to evaluate the methods of any study for strengths and weaknesses; 10) Understand how to choose a statistical test to analyze data and be able to interpret the results of any study, 11) Be able to calculate clinically useful statistics from results data; 12) Be able to decide whether to change clinical practice based on the results of a study
7750513	Clinical Trial Design	2
This course prepares the student to design and analyze randomized trials of medical interventions. Covered topics include basic study design, recruitment, randomization, masking, data collection and quality control, participant adherence, sample size considerations, data monitoring and analysis, and meta-analysis. The objectives of this course are to provide a detailed understanding of experimental study design options; methods of randomization; blinding; developing interventions and comparators; measuring outcomes and adverse effects; follow-up; compliance and postrandomization problems.
7750515	Writing Grant Proposals for Clinical Research	2
This course is designed to support students as they work to complete their training grant applications. At the time of entry into this course, students will have learned the basics of developing their research question into their specific aims in earlier grant writing courses. The course usually covers the fundamentals of good grant writing, and general preparation of the grant application (i.e., specific aims, research design, budgets, analysis of reviews and strategies for rebuttal and re-application) In this course, students complete the bulk of their writing and preparing all of the grant components so that the grant is ready for submission by the end of the term.
7750599	Thesies	6
Under the guidance of a supervisor, this whole semester course consists of writing and public defense of a Master Thesis in Clinical Research. Students shall formulate a research question of relevance within the field of clinical research, choose a methodology that can be used to find answers to the research question, use concepts, theories, and methods to analyze and answer the research question and present a written, scientifically convincing argumentation to justify the results. Each student is given a supervisor who will advise the student in the research task included in the course and in the writing of the thesis. To pass the course, the student should be able to: ? Show broad knowledge and understanding in clinical research as a scientific discipline in relation to an independently chosen research problem presented in the thesis and which is examined in relation to an opposition. ? Show a considerable degree of in-depth knowledge and understanding of the selected subject area in relation to an independent research problem. ? Show in-depth knowledge in justifying a selected method and relating it to other methods within clinical research. ? Show the ability to critically and systematically integrate knowledge about theories and methods in relation to an independently chosen research problem. ? Show the ability to analyze, assess, and manage the complexity and inquiry related to available information on the independently chosen research problem. ? Show the ability to critically, independently, and creatively identify and formulate inquiries, adequately choose methods, and plan and conduct their studies within the given time frames. ? Show both verbal and written ability to explicate and discuss their own conclusions drawn as well as those of others and the knowledge and arguments in which they are embedded in dialogue with peers. ? Show such ability required to participate in research and development work or for work in other qualified activities through verbal and written presentations. ? Show ability to make assessments concerning scientific, societal, and ethical aspects in relation to their research rationale and in relation to another thesis analyzed as part of the opposition. ? Show insights about the potentials and limitations of their own research and its function in society and about the responsibility for how it is utilized. ? Show ability to identify proposals for further research and needs for own development of knowledge about the Master thesis.
7750601	Program's Seminar I	1
Presenting one's own work to peers, instructing peers in methodologic topics, and critiquing the work of others are skills that clinical researchers will use throughout their careers. Accordingly, the Program's Seminar I will be dedicated to students presenting the current status of their research projects to their peers as well as instructing their peers in methodologic topics relevant to all clinical researchers. The specific objectives for each scholar's presentation are for 1) Scholar to get practice presenting his/her research in an oral format; 2) Scholar to receive feedback on his/her research from the faculty and the other program scholars; 3) Audience to practice critiquing the research of other investigators; 4) Audience to learn about the presenter's substantive discipline; 5) Audience to learn about a general clinical research method that they can someday apply to their own work. We strive to make these sessions valuable for both the presenter and the audience
7750602	Program's Seminar II	1
This course is similar to Seminar I. However, the student has to present the full manuscript to peers. The discussion will include results and statistical analysis. The Seminar will be set in a group and round table discussion to enhance the publishability of the student projects. The specific objectives of the second Seminar course are 1) to enhance the ability of graduate students to submit manuscripts to various journal websites according to journal guidelines, 2) to enhance the ability of students to write a cover letter explaining the strength of the submitted manuscript, 3) to enhance the ability and broaden the knowledge of graduate students to publication ethics and conflict of interest, and 4) to enhance the ability of graduate students to communicate with editors, reviewers and peers regarding details of the manuscript.

Speciality Optional Requirements Student must complete 6 credit hours

Course Code	Course Name	Credit Hours	Prerequests
410430	Pharmacoepidemielegy & Research Outcomes	2	7750501 or 410315
This course consists of an introduction to Clinical Pharmacy literature evaluation and critique, focusing particularly on drug utilization. The pharmaco-economics of drug utilization studies will be emphasised.
7750511	Data Collection and Management Systems for Clinical Research	1
Every research study involves data that must be collected, stored, updated, queried, and analyzed. While the ability to use a spreadsheet program like Microsoft Excel is an essential skill for the clinical researcher, a spreadsheet program is generally inadequate for most research data collection and management needs. This course is designed to introduce students to the core knowledge and skills necessary to 1) give students hands-on practice with the most popular desktop Microsoft Access, and the most common tool for developing web-based research data collection forms; 2) learning these tools will help students understand the conceptual material and enable them to build genuine solutions; 3) Students will build simple but functional data collection systems, and 4) they will learn to work with datasets, including updating, querying, formatting, deriving new fields, creating reports, and exporting for analysis.
7750512	Cost-Effectiveness Analysis in Medicine	2
In a world where policy-makers, donors, and payers are increasingly cost-sensitive, how does one measure return on investments in health? Cost-effectiveness analyses can help formally evaluate clinical and policy decisions, particularly when, as is usually the case, decisions have to be made with incomplete or imperfect information. this course helps students to know: 1) the principles of cost-effectiveness analysis, including estimating costs, health outcomes, and metrics of cost-effectiveness; 2) understand the effective verbal and written communication of cost-effectiveness analyses; 3) Real-world examples of cost-effectiveness analyses that influenced clinical guidelines or health policy; and 4) Specific challenges with cost-effectiveness analyses pertaining to low- and middle-income countries.
7750514	Cancer Epidemiology	1
This course will cover the basic understanding of how the principles and methods of epidemiology can be applied to the study of neoplastic diseases. The objectives for this course are for participants to: 1) Describe and compare the epidemiology of several cancer types; 2) Explain the differences between normal and cancerous cells, and the progression from a normal cell to a cancerous cell; 3) Use publicly available cancer registry data and be able to plan studies using these data; 4) Describe several key mechanisms that underlie carcinogenesis of different cancers (e.g., DNA repair defects, activation of proto-oncogenes, inherited mutations, growth factors and their receptors); 5) Advance abilities to critically evaluate and interpret findings reported in the scientific literature on cancer research topics; and 6) Demonstrate detailed knowledge regarding a particular cancer type and cancer risk factors.
7750516	Molecular and Genetic Epidemiology	2
Introduction to the concepts, principles, and use of molecular and genetic methods in epidemiologic and clinical research and how to develop a framework for interpreting, assessing, and incorporating molecular and genetic measures in research. Upon successfully completing this course, students will be able to: 1) Present fundamental concepts and methods in molecular and genetic epidemiology; 2) Review basic terminology in molecular and genetics and introduce various molecular and genetic epidemiology study designs, covering basic analysis, inferences, plus their strengths and limitations; 3) Discuss basic terminology in the field of human genetics; 4) Discuss the basic principles behind major molecular biology techniques, such as PCR, and their applications in genetic epidemiology studies; and 5) Discuss various exposures, or markers, used in genetic epidemiology studies.
7750517	Pharmacovigilance and Medication Errors	2
This course will provide students with the opportunity to learn more about and discuss the following topics: Adverse drug reactions? epidemiology and classification; Adverse drug reactions ? mechanisms; Adverse drug reactions ? monitoring and prevention; Systematic reviews of adverse drug reactions; Drug interactions ? epidemiology and mechanisms; Drug interactions ? prevention; Beneficial drug interactions?using combinations of drugs and methods of pharmacovigilance. Understand the system-based causes of medication errors in community pharmacies. Causes and prevention of medication errors in printed prescription. Error-prone in abbreviations and dose expressions.