Courses

Course Requirements for Laboratory-Based Research

• IMED 5625 (summer – year 1)
• IMED 5645 (summer – year 1)
• IMED 5630 (fall – year 1)
• IMED 6635 (qualifying exam semester – typically spring year 1)
• IMED 6680 (spring – year 1)
• IMED 9665 (fall/spring – year 2)
• Elective (CB&B 740 Clinical and Translational Informatics or an equivalent)
• Elective

Course Requirements for Patient-Oriented Research

• IMED 5661 (fall – year 1)
• IMED 5630 (fall – year 1)
• IMED 5662 (spring – year 1)
• IMED 6635 (qualifying exam semester – typically spring year 1)
• IMED 9665 (fall/spring – year 2)
• IMED 6680 (spring – year 2)
• Elective
• Elective

*All Clinically-based students are required to take IMED 5660 Methods in Clinical Research as a prerequisite the summer prior to their starting semester

IMED 5645: Introduction to Biostatistics in Clinical Investigation
Date: July 7- July 18, Monday – Friday
Lecture: 8:30AM–10:20AM
Lab: 10:30 AM–11:30AM

Location: JEH Hope 110

The course provides an introduction to statistical concepts and techniques commonly encountered in medical research. Previous course work in statistics or experience with statistical packages is not a requirement. Topics to be discussed include study design, probability, comparing sample means and proportions, survival analysis, and sample size/power calculations. The computer lab incorporates lecture content into practical application by introducing the statistical software package SPSS to describe and analyze data.

Instructor: Veronika Shabanova, PhD

IMED 5625: Principles of Clinical Research
Date: July 21- August 1, Monday – Friday, 2:00 - 4:00 PM

Location: Brady Auditorium

The purpose of this intensive two-week course is to provide an overview of the objectives, research strategies, and methods of conducting patient-oriented clinical research. Topics include competing objectives of clinical research, principles of observational studies, principles of clinical trials, principles of meta-analysis, interpretation of diagnostic tests, prognostic studies, causal inference, qualitative research methods, and decision analysis. Sessions generally combine a lecture on the topic with discussion of articles that are distributed in advance of the sessions.

Instructor: Eugene Shapiro, MD

IMED 5660: Methods in Clinical Research, II

Spring Term, Days and Times TBA By NCSP

Location

This yearlong course (with IMED 661 and 662), presented by the National Clinical Scholars Program, presents in depth the methodologies used in patient-oriented research, including methods in biostatistics, clinical epidemiology, health services research, community-based participatory research, and health policy. Permission of instructor required.

For additional information, please contact NCSP: NCSP Curriculum

IMED 5630: Ethical Issues in Biomedical Research
Fall Term, Tuesday, 3:30 - 5:00 PM
Location: Giarman Room, SHM B-201, Sterling Hall of Medicine

This term-long course addresses topics that are central to the conduct of biomedical research, including the ethics of clinical investigation, conflicts of interest, misconduct in research, data acquisition, and protection of human subjects. Practical sessions cover topics such as collaborations with industry, publication and peer review, responsible authorship, and mentoring relationships. Satisfactory completion of this course fulfills the NIH requirement for training in the responsible conduct of research.

Course Instructor: Lauren Ferrante, MD

IMED 5661: Methods in Clinical Research, II
Spring Term, Days and Times TBA By NCSP
Location TBA By Instructor

This yearlong course (with IMED 660 and 662), presented by the National Clinical Scholars Program, presents in depth the methodologies used in patient-oriented research, including methods in biostatistics, clinical epidemiology, health services research, community-based participatory research, and health policy. Permission of instructor required.

For additional information, please contact NCSP: NCSP Curriculum

IMED 9665: Writing Your K- or R-type Grant Proposal
Fall Term, Wednesday, 1:00 - 3:00 PM
Location: Yale Child Health Research Center

Students will gain intensive, practical experience in evaluating and preparing grant proposals, including discussion of NIH study section format. The course gives investigators the essential tools to design and to initiate their own proposals for obtaining career development grants. The course is intended for students who plan to submit grant proposals (for either a K-type career development award or an R-type investigator-initiated award). The course can be taken as a writer (strict deadlines for homework - a section of the proposal is due for review approximately every 2 weeks culminating with mock study section for full proposal, or as a non-writer (no homework due). Enrollment of writers is limited; approval of course director required.
Instructor: Eugene Shapiro, MD

IMED 5662: Methods in Clinical Research, III
Spring Term, Days and Times TBA By NCSP
Location TBA By Instructor

This yearlong course (with IMED 661 and 662), presented by the National Clinical Scholars Program, presents in depth the methodologies used in patient-oriented research, including methods in biostatistics, clinical epidemiology, health services research, community-based participatory research, and health policy. Permission of instructor required.

For additional information, please contact NCSP: NCSP Curriculum

IMED 9665: Writing Your K- or R-type Grant Proposal Section 1
Spring Term, Wednesday, 1:00 - 3:00 PM
Location: Yale Child Health Research Center

Students will gain intensive, practical experience in evaluating and preparing grant proposals, including discussion of NIH study section format. The course gives investigators the essential tools to design and to initiate their own proposals for obtaining career development grants. The course is intended for students who plan to submit grant proposals (for either a K-type career development award or an R-type investigator-initiated award). The course can be taken as a writer (strict deadlines for homework - a section of the proposal is due for review approximately every 2 weeks culminating with mock study section for full proposal, or as a non-writer (no homework due). Enrollment of writers is limited; approval of course director required.
Instructor: Eugene Shapiro, MD

IMED 9665: Writing Your K- or R-type Grant Proposal Section 2
Spring Term, Wednesday, 3:00 - 5:00 PM
Location: Yale Child Health Research Center

Students will gain intensive, practical experience in evaluating and preparing grant proposals, including discussion of NIH study section format. The course gives investigators the essential tools to design and to initiate their own proposals for obtaining career development grants. The course is intended for students who plan to submit grant proposals (for either a K-type career development award or an R-type investigator-initiated award). The course can be taken as a writer (strict deadlines for homework - a section of the proposal is due for review approximately every 2 weeks culminating with mock study section for full proposal, or as a non-writer (no homework due). Enrollment of writers is limited; approval of course director required.
Instructor: Eugene Shapiro, MD

IMED 6680: Topics in Human Investigation
Spring Term, Thursday, 3:00 - 4:30 PM
Location: TAC N223The course teaches students about the process through which novel therapeutics are designed, clinically tested, and approved for human use. It is divided into two main components, with the first devoted to moving a chemical agent from the bench to the clinic, and the second to outlining the objectives and methods of conducting clinical trials according to the FDA approval process. The first component describes aspects of structure-based drug design and offers insight into how the drug discovery process is conducted in the pharmaceutical industry. The format includes background lectures with discussions, labs, and computer tutorials. The background lectures include a historical perspective on drug discovery, the current paradigm, and important considerations for future success. The second component of the course provides students with knowledge of the basic tools of clinical investigation and how new drugs are tested in humans. A series of lectures and discussions provides an overview of the objectives, research strategies, and methods of conducting patient-oriented research, with a focus on design of trials to test therapeutics. Each student is required to participate (as an observer) in an HIC review, in addition to active participation in class.

Consent of instructor required.

Instructors: Karen Anderson, PhD and Joseph Craft, MD