Master's in Clinical Investigations Curriculum

A Unique Training Environment

The Master’s in Clinical Investigations program provides students with a unique educational opportunity to advance their understanding of the development, implementation, conduct and oversight of clinical investigation under the mentorship of St. Jude clinical investigators.

The Clinical Investigations program equips students with knowledge, tools and skills to enable them to:

assemble and assimilate scientific evidence
understand the principles of developing and conducting clinical trials
apply analytical tools to interpret the findings
report findings to the broader medical community
acquire leadership and management skills to implement findings that improve human health

Core Competencies

Students will be trained in multiple core competency domains, which are modeled on those developed by the American College of Epidemiology and the Association of Schools of Public Health and will serve as the core of the program. Each student is also required to demonstrate mastery of applicable core competencies through an original research project related to a specific topic as part of their training (Thesis Research Project).

Domain	Competency
Descriptive epidemiology	Produce the descriptive epidemiology of a given condition, including case definition, calculation of primary measures of disease morbidity/mortality, and appropriate comparisons by person, place and time
	Identify data from existing national and international sources
	Identify major chronic and infectious diseases, their general pathophysiology, descriptive epidemiology, and risk factors
	Know the principles of screening and of surveillance systems, including understanding the concepts of validity and reliability of screening tests; be able to calculate associated measures and know the types of surveillance systems and approaches used in disease surveillance
Problem Conceptualization	Search the scientific and biomedical literature
	Review and critically evaluate the literature
	Synthesize available information and identify meaningful gaps in knowledge
	Formulate an original and key hypothesis or statement of the research problem
Study Design	Design a study using any of the main study designs (including clinical trials and community trials)
	Understand the advantages and limitations of each design for addressing specific problems, as well as the practical aspects of their uses, including trade-offs; this understanding will be reflected in selecting the most appropriate and efficient design for a designated problem
	Calculate the requisite sample size
	Identify and minimize sources of bias; describe both the direction and magnitude of the bias and the effect of potential biases on the measures of association
	Use basic population sampling methods
Data Collection and Monitoring	Use appropriate methods of measurement; design data-collection forms assessing both exposures and outcomes; determine the validity of the instrument; identify the presence and magnitude of measurement error; adjust for measurement error when appropriate data are available
Data Collection and Monitoring	Monitor the conduct and progress of data collection; develop, implement and assess quality control measures
Data Management	Create data files appropriate for analysis; carry out the steps needed to create new variables, clean the data sets, and maintain the data
Data Analysis	Use statistical computer packages to calculate and display descriptive statistics, analyze categorical data, and perform multivariable regression, survival analysis, and longitudinal analysis
Data Analysis	Examine data for the presence of confounding and interaction (effect modification), identify their presence, and manage them appropriately
Data Interpretation	Interpret the research results, make appropriate conclusions and inferences based on results, and recognize the implications of the research results
Communication	Communicate research results orally and in writing to both scientists and non-scientists (includes presenting research proposals and preparing a manuscript suitable for publication in a scientific journal)
Ethics	Understand the concepts of human subjects protections, privacy and confidentiality in research, and awareness of particular issues relevant to the study of specific populations
Ethics	Apply this understanding as evidenced in the design and conduct of one’s own research
Regulatory Oversight	Understand the current rules and regulations that define the conduct of clinical trials including Food and Drug Administration (FDA) and European Medicines Agency (EMA) requirements
Regulatory Oversight	Understand the rationale, content and process of Clinical Trials Agreements, Material Transfer Agreements and Data Transfer Agreements
Substantive Area	Demonstrate mastery of a substantive area, including knowledge and application of that knowledge in conducting original research related to a specific topic

Through the program, students build an understanding of the relationship between clinical trials and progress in improving human health. Students also gain necessary skills to not only develop and implement independent new clinical research but also to critically appraise the clinical research of others. It is envisaged that students will master new knowledge and skills, critically examine assumptions and beliefs, and engage in an invigorating, collaborative quest for learning and personal development.

Courses and Schedule

The core curriculum of the Clinical Investigations program comprises 11 courses over two years. The courses run from week to week through Fall and Spring semesters and are listed below. Trainees take most of their coursework the first year, allowing for focus on elective course work and independent research in the second year.

The Clinical Investigations curriculum follows a hybrid synchronous and asynchronous delivery model. Synchronous class sessions occur on Tuesday/Thursday afternoons via web conference. Attendance for synchronous sessions is mandatory. Additional self-paced course content is available to students online.

Year 1
Fall Semester	Biostatistics for the Health Sciences I
	Introduction to Epidemiology
	Introduction to Patient-Oriented Research
Spring Semester	Biostatistics for the Health Sciences II
	Advanced Clinical and Translational Research Methods
	Scientific Writing and Communications
Year 2
Fall Semester	Ethical and Legal Issues in Clinical Research
	Critical Assessment of Contemporary Clinical Trials
	Elective
	Thesis Research Project I
Spring Semester	Thesis Research Project II

Year 1: Foundations of Clinical Investigation

During this year, students participate in classroom instruction and readings that seek to establish an understanding of the process of clinical investigation. The semester requires attendance in class as well as outside readings and homework. Midterm and final examinations are also given.

Year 2: Focused Clinical Investigation Project

Year 2 of the program focuses on acquisition of in-depth knowledge of the student’s career pathway. Students choose an elective course specifically focused on an aspect of clinical investigation. Through this elective course, students gain insight on how to develop a career in their specialties and begin to develop the interpersonal connections critical to success. Options for the elective course are:

Behavioral and Social Sciences
Advanced Epidemiology
Clinical Genomic Data Science
Drug Development – from Bench to Bedside
Translational Neuroscience
Implementation Science

Another course that focuses on the ethical and legal issues in clinical research familiarizes students with guiding principles and regulations necessary for the conduct of ethical research. Critical Assessment of Contemporary Clinical Trials is a seminar class that reviews recently published clinical investigation to better understand the real-world applications of their classroom learning.

Students spend the majority of their time focused on developing and completing their thesis research project. To guide the student’s progress in this project, the program directors will identify a primary subject matter expert and ensure that progress is occurring.

Master's Thesis Research Project

The thesis research project is the culmination of studies and the primary locus for translation of the knowledge and skills students acquired through the program. Students write a clinical research project, including background, justification, process and measurable results that are expected to make significant contributions to positive change. Impact may be achieved through direct action to improve human health, development of a new intervention, or a better understanding about risk or causality.