Sect Ed 103 & Ed 104: Applied Principles of Clinical Research

Several years ago, at the recommendation of students, Yale Medical School established a new requirement for all students carrying out  thesis work in clinical research areas,  including those graduating in  four years, which is participation in the Applied Principles of Clinical Research Tutoring Sessions in July and August each summer. The NIH now also requires these sessions.

Students have found these sessions to be extremely useful and have encouraged their continuation. Instructors will use examples from your applications for summer research support. It is strongly recommended that you attend these tutoring sessions that will aid you in the design and execution of your planned summer research, thesis work, and our meetings for which you will receive credit. Below is the syllabus:

Ed 103 & Ed 104          Applied Principles of Clinical Research, Nancy Kim, MD, PhD, Summer 2012 
                   

The purpose of this intensive two-week course is to provide an overview of the objectives, research strategies, and methods of conducting patient-oriented research. Emphasis is placed on applying concepts to students' actual research projects. Sessions are workshops that combine didactics and use students' projects to illuminate concepts. Participation is critical to the success of this seminar.

Seminar Leaders, Sections, Contact Information

  • Sarwat Chaudhry, MD,Assistant Professor, GIM
  • Karen Dorsey, MD, PhD,Assistant Professor, Pediatrics
  • Nancy Kim, MD, PhD,Assistant Pofessr,GIM
  • Emily Wang, MD, Assistant Professor, GIM

Administrative Assistance in the Office of Student Research

DISCUSSION SECTIONS

CONTACT INFORMATION

Sarwat Chaudhry

1:00 - 2:30 pm

July 9 - July 12

July 16  - July 19

Location: Harkness Mezzanine

203-688-2471
sarwat.chaudhry@yale.edu

Karen Dorsey

11:30 am - 1:00 pm

July 9  - July 12

July 16 - July 19

Location: Harkness Mezzanine

203-737-9227
karen.dorsey@yale.edu

Nancy Kim

11:30 am - 1:00 pm

July 10 - July 13

July 17 - July 20

Location: ESH 311 (367 Cedar Street)   

203-764-5675

nancy.kim@yale.edu

Emily Wang

July 9 - 1:00 - 2:30 pm 

July 10 -July 12 - 10:30 am - 12:00 pm

July 16 - 2:30 - 4:00 pm

July 17 - July 19 - 1:00 -2:30 pm

Location - SHM -B145 (333 Cedar Street) 

203-737-6317

emily.wang@yale.edu

Office Hours

To make an appointment, please send an e-mail with the issue that you would like to discuss and the times that you are available within a 1-2 week period; We will schedule a meeting as quickly as possible. If you have any questions or need additional information, please do not hesitate to contact us.

Readings (before class)

Readings include articles and text chapters. The readings provide a broad overview of topics for students with diverse interests.  Materials will be available in class and posted on BlueDogs.

Recommended texts

  • Stephen Hulley, Designing Clinical Research
  • Lange, Basic Clinical Biostatistics

Attendance

Students are expected to attend all tutorials in their own section.

If you are unable to attend any section during a given week you can complete a make-up assignment. This can only be done once during the summer session.

In order to receive credit for the course students must attend or receive credit for at least 6/8 sessions.

Learning Objectives

The overall objectives of these assignments are to:
  • Understand the fundamental principles of research architecture and design in the medical literature
  • Assess critically the scientific literature as presented in professional journals and the popular media
  • Construct research hypotheses and study designs to test these hypotheses

Course requirements/Grading

Course requirements are designed to focus on the development of skills and a knowledge base that should be useful as your research project develops – and beyond. 
  1. Class Participation (40%)
    All students are expected to attend and participate in class discussion.  The discussion groups provide a great opportunity to develop intellectual relationships with your peers, the Seminar Leaders, and to move your projects forward with help from the group in real time.
  2. Daily Exercises  (in class) (30%)
    This course is a brief introduction to some of the fundamental principles of patient-oriented research.  To deepen discussion and understanding of course topics, you will be asked to apply the concepts from the readings and didactics to your own research projects.
    This process is not to be a burden or to interfere with the reading itself.  The goal is to promote critical thinking, and to help students abstract a few key points from a group of readings. The ideas generated will guide our class discussion. These will be graded on quality, not the amount written.
  3. Project proposal or abstract (not to exceed 5 pp) (30%)
    A completed project proposal will be the final assignment.  It should include specific aims, hypotheses if appropriate, background, methods, significance, limitations, and human subjects sections. As with all assignments, be sure to include appropriate scientific citations.  Details for this assignment will be discussed during class.  Proposals due one week after the last class.

Schedule

  • Session 1, Research Design
    Readings: Hulley, Chs. 1, 7
    Supplementary Reading: Hulley, Ch. 8
  • Session 2, How to Ask a Research Question
    Readings: Hulley, Ch. 2
  • Session 3, Bias / Confounding
    Readings: Hulley, Ch. 9
  • Session 4, Data Collection
    Readings: Hulley, Ch. 15
  • Session 5, Qualitative Studies
    Readings: Bradley, JAMA articles (2)
    Supplementary reading: Green, Kitto
  • Session 6, How to Write a Research Proposal
    Readings: Hulley, Ch. 19
  • Session 7, How to Write a Paper/Give a Presentation
    Readings: Driscoll
    Readings: Harradine
  • Session 8,  Managing Mentors/Special Topics/Wrap up
    Readings: Sackett, Thoma
    Supplementary reading: Reynolds, DeLong