---+!! Residency Project Year One Guide Return to Residency Project Guidelines

1 - Find mentor(s)

You're ready to start your residency project, and you have picked a clinical area that interests you. How do you pick a good mentor?

  1. Your mentor needs to have clinical expertise in the area you want to study.
  2. Your mentor needs to have experience in planning, carrying out, and publishing research.

2 - Meet with mentor(s)

Choose at least 3 papers that present a similar problem. (it may be a similar patient population, a similar question/problem, or a similar disease state).

These papers do a nice job of discussing residency projects.

3 - IRB Application and Training Requirements

This document provides an excellent overview of Navigating the Clinical Trials Administrative Process at UC Davis.

Specific Site Information: At UC Davis download the IRB Expedited Review Application and complete all training required to submit an IRB application, for accessing data, and completing a research project.

Completing the IRB Application

Papers Discussing Medical Records Review

Papers Discussing the Scientific Problem and Rationale for Conducting the Study

Papers Discussing Research Methods

Using the Davis Discovery Tool, find out the data that is available to answer your question. This is an iterative process. As you work with the Data Discovery Tool, you can find number and type of patients that are available to answer. The types of patients or the questions that you ask may need to be changed as you discover what data is available to answer your question.

Specific Site Information: UC Davis

An Example of IRB Expedited Review Guidance

Specific Site Information: UC Davis

An Example of Medical Records Review Guidance

Specific Site Information: UC Davis

4 - Make Arrangements for Data Collection

Make an appointment with informatician to see about services that are available.

Specific Site Information: At UC Davis CTSC Biomedical Informatics Services. Information regarding REDCap can be found at: REDCap Services. You will also need to complete Application for Resource Use and UC Davis REDCap Project Agreement. Text describing REDCap for IRB submissions can be found at: REDCap Text.

5 - Determine Cohort and Data for Project

Review data available for your project.

Specific Site Information: At UC Davis, Cohort Discovery (i2b2) includes de-identified data from the electronic health record (EHR) and provides patient counts. The tool allows researchers to determine the feasibility of a study, determine the study cohort, and help with power calculations. For instance if you are looking for patients between the ages 18-24, male, with hypertension, Cohort Discovery will return N patients. The researcher can then include this query as a part of their IRB submission and request the identified dataset upon approval. The CTSC Biomedical Informatics program can help determine what data is available, then pull it from the EHR and deliver it through REDCap. The data should NEVER be downloaded to a laptop or any device, it should only be accessed on a secure server through a secure connection.

Where you run into problems:

6 - Meet with team:

Meet with mentor(s), biostatistician, and informatician. Review your findings.

7 - Submit IRB application.

Complete and submit IRB application

Additional Assistance

Hamann - Year 1 Residency Project Preparations
Task Operationalize
Choose a topic Draw from your own questions encountered during patient care.
  Discuss your ideas with as many people as possible.
Formulate a specific question Define the population, intervention, and outcome.
Find a mentor (or two) Discuss research, personal, and professional interests with your mentor(s).
  If you don’t “click” with someone, look for another mentor.
Identify existing institutional resources Consult with experts in your area of interest.
  Look for existing databases to help answer the question.
Detail the study design Think through each and every step of data collection.
  Anticipate what problems may arise.
  Create a database.
Complete the institutional review board (IRB) paperwork Call the IRB directly for questions related to category of review.
  Make sure your study is HIPAA compliant.
  Determine whether informed consent is necessary (ask the IRB).
Consult with a statistician Clarify what a clinically significant finding would be.
  Perform a power calculation.
  Determine the statistical tools you will need after data collection.

This topic: CTSpedia > WebHome > EducationalMaterialsBERD > ResidencyTrainingPrograms > ResidencyProjectGuidelines > ResidencyYearOne
Topic revision: 16 Aug 2012, MaryBanach
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