Section: Module 4: Nuts and Bolts of Research Design and Human Subjects Research | Training in Practice Based Research TIPR

Presented by Susan Hughes

Objectives

After this module, trainees should be able to:

Part 1:

1. Describe how the type of question determines study design

2. Be able to name three common clinical research study designs

3. Discuss the importance of human research subject protections

Part 2:

4. Name the key steps to experimental design

5. Explain why the best design to answer a treatment question is: randomized, blinded, controlled

Select activity Lecture 4.1: Residency training, researach design and human subjects

Lecture 4.1: Residency training, researach design and human subjects Media Resource
Select activity PDF of Lecture 4.1

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Select activity Module 4.1 knowledge check

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Select activity Lecture 4.2: Residency trainining, experimental research design

Lecture 4.2: Residency trainining, experimental research design Media Resource
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Select activity Suggested readings
Suggested readings Folder
Section 4.1
Designing Clinical Research, Section II: Study Designs Chapters describing components of different study designs that are commonly used in clinical research.
Chapter 8: Designing Cross-Sectional and Cohort Studies. Designing Clinical Research. Steven R. Cummings and Alka M. Kanaya
Chapter 9: Designing Case-Control Studies. Designing Clinical Research. Steven R. Cummings and Alka M. Kanaya
Chapter 10: Estimating Causal Effects Using Observational Studies. Designing Clinical Research. Steven R. Cummings and Alka M. Kanaya
Section 4.2
Designing Clinical Research, Section II: Study Designs Chapters describing components of different study designs that are commonly used in clinical research.
Chapter 11: Designing Randomized Blinded Trials. Designing Clinical Research. Steven R. Cummings and Alka M. Kanaya
Chapter 12: Alternative Interventional Study Designs. Designing Clinical Research. Steven R. Cummings and Alka M. Kanaya
Select activity Optional additional readings and resources

Optional additional readings and resources Folder
Select activity Module activity
Module activity Assignment

Opened: Monday, August 1, 2022, 12:00 AM

Due: Sunday, June 25, 2023, 12:00 AM

Students must

Mark as done
Complete the CITI Human Subjects Protection Training course online at www.citiprogram.org and share the certification form with your faculty mentor.
See reference document, CITI registration 2021, if you need help registering (under optional reading). Note, if you have a current CITI certificate you will only need to add an affiliation to UCSF and possibly complete additional module(s).

UCSF requires you to take 4 core modules and 2 modules of your choosing. See list of options in reference document, UCSF CITI training modules. You can take additional optional modules on other topics, if you wish.

We suggest selecting something pertinent to your question (e.g. protected populations or behavioral). Ask your mentor for suggestions if you can’t decide.
Based on your readings, if you were to approach your research question as a clinical research study, what designs are most appropriate and why? In one page, propose a clinical research design to answer one of the study questions you are considering for your project, and discuss how you would structure your research question. Include a brief consideration of the following questions in your proposal:
Is it feasible to carry out this research with the time and resources you have available to you?
Why did you select this design over other methods?
Select activity Module 4.2 knowledge check

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Select activity Module 4 evaluation

Module 4 evaluation Assignment

Opened: Friday, July 5, 2024, 12:00 AM

Due: Friday, July 12, 2024, 12:00 AM

Section outline