*All courses offered by the MS-CTR  and Graduate Certificate programs have an ONLINE/SYNCHRONOUS component*


CLTR500 Research Ethics with Human Subjects - 3 Credits - ONLINE
Course Director: James Giordano, PhD 
This interactive case-based course explores ethical considerations and issues pertaining to scientific research, especially biomedical research with human subjects. Issues regarding scientific integrity, ethical research design and implementation, and research involving special populations are analyzed. Certification of training in the protection of human subjects is accomplished during progression through the material. The foundational principles of the Belmont Report underlying the responsible conduct of research are explored fully in the core content areas of human subjects, conflicts of interest and commitment, collaborative science, data acquisition, management, sharing, and ownership, publication practices and responsible authorship, mentor/trainee responsibilities, peer review, and research misconduct. The course is designed to help participants become comfortable with the language and literature of research ethics through the analysis stakeholder interests and perceptions using case studies presenting moral dilemmas in research ethics. This course is especially helpful to clinical investigators and members of Institutional Review Boards (IRB) as the application of federal regulations to particular cases is probed in depth.
Fall Term
CLTR 501 Introduction to Biostatistics in Clinical Research - 3 Credits  - ONLINE
Course Director: Nawar M. Shara, PhD 
This course provides a foundation for current and future thinking in terms of practical aspects of the importance of biostatistics in conducting clinical research and thereafter translating its findings. One purpose of this course is to make the student aware of the complexities of the relationships between biostatistics and clinical research, particularly as they pertain to decision making. This course provides students a scientifically oriented perspective on the types of information that is integral for the proper design and conduct of clinical research. The goal is to improve students’ conceptual understanding of the differences and similarities among the different inferential tests, and the appropriate use of statistical tests. Assessments target articulation of arguments and decisions involving, or based on, fundamental aspects of biostatistics in the context of medical research. Each of the modules are enhanced by examples using PRISM software (GraphPad). 
Fall Term
CLTR 502 Clinical Research Administration - 3 Credits - ONLINE
Course Directors:  Shaunagh Browning, RN, FNP
This course prepares students to implement successful clinical investigations. Specifically, this course teaches how to establish a clinical research practice, understand and apply the federal and local regulations governing clinical research, develop, implement and financially-manage a protocol. As well, it addresses assurance of study quality, private and reliable data systems, intellectual property, and the identification and resolution of problems and risks. Student performance is evaluated by periodic quizzes covering content from several lectures, class participation, and a final examination. 
Fall Term 
CLTR 503 Core Clinical and Translational Research Seminars - 1 Credit - ONLINE
Course Director Jason G. Umans, MD, PhD 
This weekly CCRS anchors the entire CTR curriculum and supplements both coursework and mentored research by bringing together all students along with CTR Scholars in GHUCCTS faculty and research development programs to: 1) share issues and challenges in design and execution of CTR; 2) host monthly presentations by outstanding clinical investigators; 3) host monthly presentations by outstanding translational investigators; and 4) provide the forum for a monthly interdisciplinary CTR journal club and stimulate cross-disciplinary approaches and collaborations. 
Fall  & Spring
CLTR 504 - Project Development in Clinical Research - 1 Credit - ONLINE
Course Director: Jason G. Umans, MD, PhD
This interactive course focuses on applying knowledge experimental design, biostatistics, and research ethics to trainee specific proposal.  Students will work in groups to identify a researchable question and study hypothesis, and consider alternative approaches to study design, participant recruitment, and data collection.
Following the introduction session, the students will submit a draft project title.  Students should work with their mentors to produce a first rough draft of a grant for submission to NIH as well as industry sponsors. 
Fall & Spring
CLTR 505 Social and Behavioral Aspects of Public Health - 3 Credits -  ONLINE
Course Director: Carla Williams, PhD 
Aspects of the social and behavioral sciences (e.g., psychology, sociology, and anthropology) that are applicable to public health will be reviewed and their applications defined through case studies and presentations by public health leaders. 
Fall Term
CLTR 506 Study and Clinical Trial Design - 2 Credits - ONLINE
Course Director: Nawar M. Shara, PhD 
This course builds upon the introductory statistics concepts and skills developed in the first term, extending them to practical application in study and clinical trial design and interpretation. Topics include structural aspects of clinical trials, protocol design, randomization and blinding, issues of error, bias and hypothesis testing, selecting and working with trial outcome variables, issues in safety versus efficacy trials, power and sample size calculations, secondary subgroup and exploratory analysis. 
Spring Term 
CLTR 507 Epidemiologic Methods - 3 Credits -  ONLINE
Course Director: Loral Patchen, PhD
This course provides an overview and introduction to epidemiology, particularly as it relates to the design, interpretation and importance of clinical (experimental) research. Topics include understanding association and causality; cross-sectional studies and surveys. The design, analysis, and interpretation of case-control and cohort studies are emphasized together with sources of bias in both contexts. Other topics include population attributable risk; confounding factors; effect modification (interaction); analysis for confounding and interaction. This course builds on the multivariate analysis techniques and analyses for sensitivity, specificity and screening that were introduced in the introductory biostatistics course. 
Spring Term
CLTR 508 - Capstone Project  3-6 Credits -  ONLINE
Individuals pursuing the MSCTR will be required to complete a final project in which they will design and develop a clinical or translational research proposal or in which they will conduct and report the results of a clinical or translational research project, including the option of a secondary analysis of existing data. Students should demonstrate and apply skills and knowledge gained in the in the MSCTR coursework to their approved final project.
The capstone project must be designed and approved by a research mentor and by the student’s faculty advisor (a member of the Program Faculty) and Program Director. To obtain approval, the trainee must submit a one-two page concept paper in the first or second term of his or her course of study. The Final Project Approval form must provide a brief description of the intended project and must be approved by the trainee's advisor and the Program Director. 
Summer Term


BCHB 572 Bioinformatics - 2 Credits
Course Directors: Danielsen M., Roberts, Natalia 
A mixture of lectures and hands-on sessions on the bioinformatic analysis 
of protein sequences, covering phylogenetic analysis, sequence alignment, protein family classification and structural and functional analysis. 
Students should take either BCHB 572 or BCHB 521 but not both. 
Permission of course director required. 
BCHB-594 Translational Bioinformatics - 3 Credits
Course Directors: Yuriy Gusev, Sona Vasudevan, Raja Mazumder 
This new didactic course is a one semester course that will cover major concepts, methods and tools used in translational bioinformatics. It is designed as a combination of lectures and practical computer based exercises utilizing functionality of web-based GU resources - such as Protein Information Resource (PIR), and Georgetown Database of Cancer (G-DOC) - a unique translational research platform for connecting molecular and clinical data. Additional hands-on experience will be provided to students in the applications of advanced systems biology level analysis of experimental multi-omics data using Pathway Analysis tools from Pathway Studio software suite (Ariadne Genomics). A campus-wide license for Pathway Studio is available to all GU students
BCHB 591 Biomedical Informatics - 3 Credits 
Course Directors: Sona Vasudevan, Subha Madhavan, Alan Zuckerman, Robert Jenders - 
This new didactic course will provide an overview of the field of Biomedical Informatics from different perspectives. Particular emphasis is given to understanding the basic building blocks, various information resources and the application areas of Biomedical Informatics. Students will learn to explore the process of developing and applying computational techniques for determining the information needs of health care providers and patients. 
BCHM 580 Systems Biology and Related Technologies - 3 Credits 
Course Directors: Nathan Edwards, Habtom Ressom & Rado Goldman 
This didactic course will introduce the basic concepts of systems medicine and systems biology and the key “-omic” and other related technologies. This course will introduce students to bioinformatics in systems biology, covering microarray data analysis, proteomic informatics, and regulatory network and pathway analysis, and discuss how a systems approach to the analysis of “omics” data can improve our understanding of biology.
PBIO 566 Fundamentals of Molecular Biology & Genetics - 1 Credit

Course Director: Thomas Sherman, PhD
Fundamentals of Molecular Biology & Genetics is a one-credit, graduate school course taken during the fall semester. This course is designed to complement the medical BCHB-560 and 561 courses. Topics include structure of DNA, genes and chromosomes; DNA replication and repair; cell replication; control of gene replication; and the basic principles of genetics and heredity. 

BCHB-522 Drug Targets and Drug Design - 1 Credit 
Professor Chirikjian, Eiden and Helling
This course is designed to provide students with a comprehensive background in the history of pharmacology and therapeutics leading to the current theory and practice of drug design and the basic pharmacology, biochemistry, molecular biology and bioinformatics concepts that drive it. An understanding of fundamental biological and biotechnological concepts required to assess current and future approaches to drug discovery along the "critical path" from basic biomedical research to identification of cellular and molecular mechanisms of disease, drug targets, and rational design and high throughput screening of drug candidates will be gained. 

CLTR597- Introduction to Safety and Quality - 4 Credits - ONLINE
Course Director:  Anne J. Gunderson, M.S., Ed.D. 
The first week of the SQL program will focus on introducing students to the Georgetown University on-line library collection and providing instruction regarding the conduct of a thorough and rigorous literature review.  Faculty will provide guidance on techniques for the critical review of scientific and scholarly articles. This course will introduce learners to relevant theory, content, tools and methods in the field of patient safety and health care quality. This course also focuses on the historical concepts and current issues of patient safety and quality care. Through this course learners will begin exploring techniques for effective improvement science and define quality and select/develop meaningful metrics reflecting patient safety and clinical quality for an organization.
Summer Term
CLTR599- Quality Improvement Methods - 4 Credits - ONLINE
Course Director:  Anne J. Gunderson, M.S., Ed.D.
Learners will gain working knowledge of basic quality improvement tools, data collection and analytical methods, and project management techniques that are common in the implementation, evaluation, and study of healthcare quality and safety.  Through sessions focused on fundamental concepts of systems-thinking, improvement science, and data collection, organization, and analyses, students will learn to create and use data to answer empirical questions.  The course content will provide a basic understanding of quality metric concepts. Basic statistical tools for data analyses, interpretation, and presentation will prepare learners to critically evaluate quality improvement policies, reports, and measures of clinical performance, efficiency, healthcare quality, and patient safety. Learners will encounter techniques for effective improvement science, quality, and select/develop meaningful metrics reflecting quality for an organization. Learners will continue the development of their capstone project during this course. 
Fall Term
CLTR700 Aspects of Drug Development - 3 Credits -  ONLINE
Faculty: M. Scott Harris, MD
In a blending of online and live learning, this course will provide an overview of the process and issues common to all drug development projects, with particular attention to the new chemical entity (NCE). The course will focus on the decisions that need to be made throughout the drug development process and the criteria influencing these decisions. The faculty for this flagship course are experts in their fields. The curriculum will review how molecular targets are identified and how compounds (both small molecules and biologics) are optimized for specificity and pharmacokinetics, minimalizing drug-drug interactions and off-target effects. The course will cover the Investigational New Drug (IND) applications, including the preclinical safety and toxicology studies required to enable these applications; first-in-human trials; pharmacokinetics in humans; drug-drug interactions; proof-of-concept studies; confirmatory trials leading to the filing of a New Drug Application (NDA) or Biologics Licensing Application (BLA) in the US and Marketing Authorization Application (MAA) in Europe; and post-marketing pharmacovigilence. Manufacturing issues and standards unique to small molecules and biologics will also be addressed. The course will review federal and international regulations governing clinical research. Credits: 3
Spring Term
CLTR 803 Global Health in Research - 3 Credits - ONLINE
Course Director: Irene Jillson, PhD
This course is designed to introduce students to the practice of global health research, with a focus on but not limited to the conduct of research in developing countries. This is both a principles course, in which mastery is obtained through class lectures, readings, discussions, and research groups regarding health research, and a skills course in which mastery is obtained through the development of research proposals, the structured review of peer-reviewed health research articles, and the completion of the online CITI course for the protection of human subjects. The course emphasizes the scientific method as a mode of inquiry applied to quantitative, qualitative and mixed method research. It considers particular issues related to global health research, including: the use and interpretation of secondary data; cultural, linguistic, socioeconomic and other considerations in study design, data collection instruments, study methods, and analysis and interpretation of data; involvement of donors in funding and conduct of health research; opportunities for and considerations in collaborative global health research; and ethical issues and related to global health research.
Spring &Summer Terms
CLTR 804 Qualitative Methods in CTR - 3 Credits 
Course Director:  Pamela Saunders, PhD
This course is the introductory course in qualitative research methods offered for students in the MS-CTR program.  Students require training in foundational aspects of research methods, study design and data analysis.  Many clinical research projects include qualitative methods as part of the study design. This  course is designed to give students an understanding of the logic, tools, and practice of qualitative research methods as they have evolved and are currently being used in research in clinical and translational sciences. The focus of this course is on the paradigmatic assumptions of qualitative research; qualitative design, and methods and strategies of data collection. 
Spring Term

CLTR 800 – Introduction to Community Engagement in Translational Research - 3 Credits - ONLINE
Course Director:  Carla Williams, PhD
This course introduces social science and behavior theory concepts in understanding of health disparities and research in this area. It provides students with an introduction to community engagement principles and offers the necessary foundation for translating research into practice. Topics include: defining community engagement and its guiding principles; role of community engagement in translational; foundations in behavioral science (theory); practice-based research networks; data collection; resources; program evaluation; and ethics in community engagement research.
Fall Term
CLTR 801-Cultural Competence in Translational Research -  3 Credits 
Course Director: Souzan Hawala-Druy
This inter-professional /interdisciplinary course is designed to help students increase awareness and knowledge of how the delivery and acceptance of health care may be influenced by social, cultural and environmental factors and increase the delivery of culturally competent care (individuals, families, communities, institutions) to reduce health disparities. Students will be introduced to how to craft respectful, reciprocal and responsive effective interactions across diverse cultural boundaries. The course will utilize cultural concepts; theories and models; cultural assessment; critical thinking; and evidence-based practice appropriate for developing knowledge. Students will be able to analyze cultural factors that facilitate/hinder communication (researcher/ participants & inter-professional team from diverse professions and cultures) in recruiting research participants. Furthermore, experiential activities and practical applications of the learned classroom material will contribute to life-long learning.
Fall Term
CLTR 802 -Elimination of Racial and Ethnic Disparities in Health - 3 Credits - ONLINE
Course Director: Kimberly Henderson, PhD 
There is convincing evidence that most racial and ethnic minorities in the United States experience health disparities as compared with the majority of the population. These disparities differ in the several minority groups but they all result in limiting the length and quality of life of many members of this group. The public health profession has taken as one of the its major challenges the need to eliminate these health disparities within the next decade. 
Summer Term

PHARM 620 Introduction to Regulatory Science - 2 Credits - ONLINE
Course Director:  Erin Wilhelm, MPH
Regulatory science is an applied scientific discipline that generates and makes use of evidence-based knowledge to inform decision-making about the safety and benefits of medical products. This survey course will examine the myriad issues that arise in the field of regulatory science, and will introduce students to fundamental principles of regulatory science, describe the differences between regulatory science and regulatory affairs, and provide an overview of the innovative clinical research tools of regulatory science. Building upon the Food and Drug Administration’s (FDA) Strategic Plan: Advancing Regulatory Science at FDA (August 2011), individual classes will focus on the eight priority areas defined by the FDA as necessary for advancing regulatory science. Expert lecturers from Georgetown University and the FDA will present case studies, best practice examples, and guide discussion of key issues.
Fall Term

CLTR900 – Analytic Approaches for Regulatory Health Science - 3 Credits - ONLINE
Course Director: Erin Wilhelm, MPH
Regulatory science analytic approaches include patient-reported outcomes, scientific methods to gather and validate information through systematic reviews, and the use of biomedical informatics. These techniques synthesize quantitative research by systematically searching literature or datasets for areas in which sufficient (and sufficiently comparable) data has accumulated. This course will introduce students to systematic reviews and meta-analysis methods, patient-reported outcomes, and biomedical informatics as analytic tools and approaches used in regulatory science, clinical effectiveness research, and translational research. Students will learn how to use a variety of methods for identifying, evaluating, and synthesizing information from randomized controlled trials and observational studies, assessing the strength of the evidence, and translating the results into regulatory decisions, as well as policy and practice guidelines. Concepts are introduced and illustrated through analysis of drug and vaccine safety and efficacy studies as well as other public health and medical case studies. The use of health data mining techniques to explore data and identify sources of variation among studies is emphasized, as is the use of meta-analysis to identify future research questions. Patients-reported outcomes and the growing need for biomedical information technology tools, advanced biostatistics methods, and health data mining techniques are emphasized throughout the course and by utilizing relevant real-life examples. Working in groups of three to five individuals, students will be expected to carry out a written research synthesis of a public health or clinical topic of their choosing. Intermediate results will be presented and discussed in class.
Spring Term

CLTR904 – Approaches for Assessing Safety, Quality, and Benefit  - 3 Credits  - ONLINE
Course Director: Valeriy Korostyshevskiy, PhD
This course will examine the development and application of new or existing methods along the development pipeline to assess quality and safety of medical products for use in humans. The course will explore the various methods to ensure safety and quality for research participants, patients in treatment, and the public health. Modern tools and methods can analyze clinical data and inform regulators about the safety of medical products and ensure the quality of emerging technologies (i.e., nanotechnologies). Students will learn terminology, approaches, and current practices by which regulators assess quality and safety as well as how novel approaches are incorporated into the regulatory review process to account for latest advances in science. Concepts are introduced and explored in a step-wise fashion through the use of case studies. A series of short essay exams will be administered throughout the semester to gauge student learning and comprehension of the basic assessment approaches before continuing to more advanced concepts. 

Prerequisites: Introduction to Biostatistics in Clinical Research or an equivalent. Spring Term

CLTR905 – Communicating Risk and Benefit for Public Health - 2 Credits  - ​ONLINE

Course Director: Erin Wilhelm, MPH
“Organizations bear economic, legal, and ethical obligations to provide useful information about the risks and benefits of their products, policies, and services.”2 Risk Communication is a state-of-the-art term for communications meant to help people make informed decisions about whether and how to address the risks they encounter. The topics covered in product risk communications, however, typically should not solely be about risk, in that people must understand product-related benefits to be able to effectively evaluate product-related risks. Communications about public health product risks and benefits focus on accuracy and comprehensiveness, thereby differing significantly from typical public relations and many public affairs communications. Regulatory Science should prepare health professionals and the public to make informed decisions about medical, food, and tobacco products. This course will introduce students to the complexities of planning, implementing, and evaluating risk communications in circumstances where all public communications are affected by varying regulatory and legal constraints. The course will explore the perspectives of different key actors, including product developers, manufacturers, advertisers, regulators, and users – both professional and non-professional. The course will introduce critical concepts through didactic lecture (exposing students to core strategies, considerations, and the analyses required to develop and test effective risk communications) and discussion. Students will discuss real-world risk communications examples, and will identify areas where different strategies might have had different effects. Using the concepts learned and learning from the course, students will prepare a term paper describing an ideal process for planning, implementing, and evaluating a risk communication for a specific new medical product, the characteristics of which will be developed with the assistance of the instructor. Students’ ability to apply the lessons, classroom discussion, and readings also will be evaluated from responses to midterm and final exams.
Spring Term