Clinical Investigation Curriculum

Course ID: AMC 501

For research, student must choose a laboratory and a mentor of their interest. The number of credits is determined by the student and mentor. These credits are earned during thesis research in the laboratory. The goal of research is to provide supervised experience in designing, conducting a research project and then writing up results of research projects, or in reviewing and synthesizing a body of research literature. Learning assessment includes mid-semester and end-of semester evaluations completed both by mentor and student.

MS and Certificate

Course ID: AMC 503

During each journal club, a student or faculty will present critical reviews of papers in subject matter to a group’s interest. The student will be given a list of existing journal clubs (basic science and clinical to attend). A minimum of 10 journal clubs must be attended. The Department of Neuroscience and Experimental Therapeutics (DNET) journal club includes options for basic science articles as well as clinical journal club (DNET with psychiatry). The student will need to present a minimum of one peer-reviewed journal article during journal club (usually a PowerPoint slide presentation). With the permission of the mentor and the Certificate in Clinical Investigation steering committee, other journal clubs may be substituted. Learning assessment involves feedback on class participation.

MS and Certificate

Course ID: AMC 508

The purpose of this course is to provide learners with an introduction to ethics in clinical research, as well as provide them with the fundamental institutional certification for conducting research with human subjects. Learners will prepare for and take three Collaborative Institutional Training Initiative (CITI) training modules: Biomedical Investigators Training, Good Clinical Practice (GCP) and Human Subjects Research. They will also attend separate lectures on biomedical research ethics and medicine and human rights. Bioethics Case Conferences will be attended monthly, and learners will prepare an 800-1000-word reflection on 6 of the presented cases. Learning Assessment is based on attendance at 6 of the 9 Case Conferences is mandatory and an 800-1000-word reflection on 6 of the Case Conference presentations/discussions will be due by the end of the course.

MS and Certificate

Course ID: AMC 509

This is an intensive, hands-on, advanced course in writing for publication in biomedical journals, how to be a successful peer reviewer, and how to communicate research findings to a broad audience. Learners will be expected to draft all components of a research paper, respond to two peer review cycles and, at the conclusion of the course, to write a manuscript that may be suitable for submission to a peer-reviewed journal, as well as a shorter, Media Communication article. Learners will also prepare and present both a poster and a 10-minute oral presentation on that topic to the class. There will be lectures on nuances of writing each component of a paper, poster and presentation and learners will submit their own version for peer review during class. Based on these edits, learners will complete the portfolio as described at the conclusion of the course. Learning Assessment is based on written assignments, including final manuscript submission, peer review, and presentations.

MS and Certificate

Course ID: AMC 550

The goal of this course is to provide a practical context for learners to gain skills and processes for conducting clinical trials. The course encompasses group activities using interactive case studies with realistic scenarios illustrating how clinical trial regulations and guidelines impact each situation. It provides an overview and in-depth introduction to principles of clinical research, utilizing reading, protocol development and seminars. Brief mini-lectures to review concepts are followed by in-class discussions built on assigned reading and exercises. Formative assessments (pre-tests) will be included for some session material. Each learner will develop a research protocol that describes in detail the aims, background, and study plan for an investigation to address a research question formulated by the student. This protocol will be developed following an iterative process, and learners will receive feedback in individual and small group protocol review sessions. Learning assessments include class participation, written and oral assignments and pre-and post-session quizzes.

MS and Certificate

Course ID: AMC 601

This course provides the fundamental information to understand, evaluate and design clinical research studies. Students will learn multiple aspects of clinical study design, including participant selection, sample size estimation, cohort, case-control and cross-sectional designs, and experimental design of clinical trials. Students will also become proficient with common statistical analyses used in clinical studies. Regulatory components of clinical trials, such as quality control and database management will be discussed. Finally, research software including STATA, Redcap and Qualtrics will be covered and students will develop a Qualtrics questionnaire or other assessment tool. Learning Assessments include practice problems, graded problem sets, self-assessments, exams, and quizzes.

MS and Certificate

Course ID: AMC 602

This course introduces the scope and study of bioinformatics. This course serves as the foundation for further study in this interprofessional multidisciplinary field. It provides students with specialized knowledge and skills needed to support the adoption and use of health information systems and data analysis for a variety of Clinical, administrative and research purposes. It introduces R and the topics include fundamental concepts of data mining and data preprocessing, knowledge representation and visualization, cluster analysis, basic concepts of epidemiology and an overview of practical tools for discovering knowledge from medical data. These topics are illustrated by examples of practical applications in health care. Learning Assessment is based on mid-term exams, final exam and assignments.

MS only

Course ID: AMC 600

This course is designed to prepare students to be able to use basic statistics in order to perform appropriate statistical analysis of their research so they can determine if appropriate analysis was performed when reading the literature in their field of study. The first part of the course is lecture/exercise-based sessions run by the faculty that exposes students to basic principles and tests commonly used in biostatistics, including sessions on what inferential statistics is and determining the statistical analysis as part of your experimental design. In the second part of the course students bring in experiments and/or data from their laboratory and describe the experimental design and the statistical test that was used (or will be used) to analyze the data and how this allowed (or will allow) them to formulate a conclusion from the data. Learning assessment involves graded homeworks, quizzes and tests.

MS and Certificate

Course ID: AMC 603

This course is designed to provide the student the fundamental knowledge necessary for writing research grants and understanding the grant review process. The course will focus on what should be included in the different sections of a NIH research proposal (Research Plan Section). To emphasize the purpose of this information in supporting the grant proposal, students will be provided with sections of well written proposals, as well as proposals that did not do well in study sections. Discussions of these examples will highlight how proposals can be improved.

As part of each module, students will write (1) a Specific Aims page, (2) a Significance and Innovation section, and (3) an Approach section that is focused on one of the specific aims. Students will then read and critique one another’s written assignments and discuss their reviews using a study section format. Students will then revise each section in response to the reviewers’ critiques. The course will culminate in a mock study section performed by AMC faculty with experience serving on NIH grant review panels, in order to demonstrate how the grant peer review process works at the NIH. Learning assessment involves peer and instructor feedback in written critique form.

MS and Certificate