Course guides research scholars through the essential components for writing a clinical research protocol, developed around their own clinical research question. The course covers hypotheses, specific aims, study types, sample size estimation, power calculations, and data analysis. While the course work is especially applicable to residents, all researchers and scholars can benefit from the learning about creating a clinical research protocol. All enrollees are welcome. Please see Prerequisites below.
- Describe study design, data analysis and management, sample size calculations, and power calculations.
- Identify the inferences that may be drawn from findings of clinical research studies.
- Draft a five-page clinical research protocol for use in your proposed research projects.
- Provide peer review and be able to helpfully critique your co-learners' protocols.
Designing Clinical Research for Clinical Trainees (DCR-CT) Online is a 6-week course. Participants are expected to devote at least 6 hours per week to individual work and online peer interaction. Topics include:
- Review Course Instructions
- Small Group Sync Session: Getting Started
- The Research Question
- Study Designs
- Subjects and Variables
- Enhancing Causal Inference
- Sample Size and Power
- Questionnaires and Qualitative Research
- Ethical Considerations in Clinical Research
- Final Protocol Due
- Final Protocol Critique
Hulley, Stephen B.; Cummings, Steven R.; Browner, Warren S.; Grady, Deborah; Hearst, Norman (2013). Designing Clinical Research. Lippincott Williams & Wilkins. 378 pages - ISBN 1608318044.
Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing.
All participants are required to develop a five-page clinical research protocol that can be used in their proposed research projects. The suggested protocol format is as follows:
- Title and Investigators
- Research question
- Specific aims
- Overview of design
- time frame and nature of control
- Study subjects
- selection criteria, target and accessible populations
- plans for sampling, recruiting and retaining subjects
- predictor variables (intervention if an experiment) and potential confounders
- outcome variables
- Statistical issues
- hypotheses and sample size estimates
Protocols are developed in four iterative steps. For each step, learners are required to post their work within the course site and then engage in peer review (giving and receiving of feedback) before moving on to the next step. To maximize the value of peer feedback and dialogue, learners are expected to log into the course site and engage with others at least three days per week.
- Sample Protocol #1 by Elizabeth Cedars (pdf 70KB)
- Sample Protocol #2 by Todd Driver (pdf 120KB)
- Sample Protocol #3 by Victoria Parikh (pdf 70KB)
Faculty and Staff
Designing Clinical Research draws on the experience and expertise of a stellar team of researchers. Your specific course will include lecturers and section leaders such as:
- Douglas Bauer
- Kirsten Bibbins-Domingo
- Steven Cummings
- Deborah Grady
- Jeff Kohlwes
- Miriam Kuppermann
- Bernard Lo
- Charles McCulloch
- Kala Mehta
- Thomas Newman
- Emily von Scheven
Online Learning Guide (Course Concierge)
Christian Leiva is the Coordinator of the Resident Research Training Program, the K Scholars Program, and the Pre-Health Undergraduate Program for the Clinical and Translational Science Institute at UCSF. Mr. Leiva was previously the Fellowship Coordinator for the Division of Endocrinology and Metabolism. He has been working as an administrator of the online version of Designing Clinical Research for Clinical Trainees since 2012.
- Current dental, medical, nursing, pharmacy student or resident, or postgraduate clinical trainee. Others who do not meet these criteria are welcome and may apply.
- All participants must provide a research question they will work on throughout the course. All participants must have a mentor with whom they will work throughout the course and beyond.