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

• During the first year of your residency project, you will be designing and preparing your Electronic Medical Records Review Study. By the end of the first year, you will need to file your IRB expedited review application. Herein, we provide links to assistance, references and guides for helping you through the first year preparations.

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.

Pick the title and click Go A Methodology for Conducting Retrospective Chart Review Research in Child and Adolescent Psychiatry Clinical research during internal medicine residency: a practical guide Contemporary Issues in Medicine: Basic Science and Clinical Research; Report IV of the Medical Schools Objective Project Common Program Requirements for: Residency Resident research in internal medicine training programs Training physician-scientists: a model for integrating research into psychiatric residency Conducting a successful residency research project Structured research training in residency training programs. The impact on the level of resident research activity Resident research education in physical medicine and rehabilitation: a practical approach Being successful with family medicine residency research: lessons learned from others Getting residents involved in research: a challenge in the era of managed care A curriculum for producing resident researchers A novel curriculum for teaching research methodology The PRIME curriculum clinical research training during residency: response to Kohlwes et al Resident research and scholarly activity in internal medicine residency training programs Factors associated with citation of internal medicine residency programs for lack of scholarly activity The PRIME curriculum. Clinical research training during residency How to develop and critique a research protocol A consortium-based research education program for residents Development of a national course on research methodology for Canadian residents in obstetrics and gynecology A systematic review of resident research curricula The research rotation: competency-based structured and novel approach to research training of internal medicine residents Integrating research training into residency: tools of human investigation Promoting Translational and Clinical Science: The Critical Role of Medical Schools and Teaching Hospitals A Practical Guide for Health Researchers

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

• Describe the study format - Electronic Medical Records Review

Papers Discussing Medical Records Review

Pick the title and click Go Methodology to improve data quality from chart review in the managed care setting Medical record review conduction model for improving interrater reliability of abstracting medical-related information Chart documentation quality and its relationship to the validity of administrative data discharge records Guidelines were developed for data collection from medical records for use in retrospective analyses Pragmatic strategies that enhance the reliability of data abstracted from medical records Chart review. A need for reappraisal The art and science of chart review Advanced statistics: understanding medical record review (MRR) studies Coding data from child health records: the relationship between interrater agreement and interpretive burden Methods to achieve high interrater reliability in data collection from primary care medical records Definition, structure, content, use and impacts of electronic health records: a review of the research literature Ensuring high accuracy of data abstracted from patient charts: the use of a standardized medical record as a training tool ICES Report: Using Data from Electronic Medical Records: Theory versus Practice Data Quality of General Practice Electronic Health Records: The Impact of a Program of Assessments, Feedback, and Training Using your electronic medical record for research: a primer for avoiding pitfalls

• Describe the specific aims, hypothesis, and scientific problem.*

• Provide the rationale for conducting the study and the importance of the knowledge to be gained (if not addressed in the previous question) and provide background information with references, if available.

Papers Discussing the Scientific Problem and Rationale for Conducting the Study

Pick the title and click Go A Methodology for Conducting Retrospective Chart Review Research in Child and Adolescent Psychiatry Clinical research during internal medicine residency: a practical guide Contemporary Issues in Medicine: Basic Science and Clinical Research; Report IV of the Medical Schools Objective Project Common Program Requirements for: Residency Resident research in internal medicine training programs Training physician-scientists: a model for integrating research into psychiatric residency Conducting a successful residency research project Structured research training in residency training programs. The impact on the level of resident research activity Resident research education in physical medicine and rehabilitation: a practical approach Being successful with family medicine residency research: lessons learned from others Getting residents involved in research: a challenge in the era of managed care A curriculum for producing resident researchers A novel curriculum for teaching research methodology The PRIME curriculum clinical research training during residency: response to Kohlwes et al Resident research and scholarly activity in internal medicine residency training programs Factors associated with citation of internal medicine residency programs for lack of scholarly activity The PRIME curriculum. Clinical research training during residency How to develop and critique a research protocol A consortium-based research education program for residents Development of a national course on research methodology for Canadian residents in obstetrics and gynecology A systematic review of resident research curricula The research rotation: competency-based structured and novel approach to research training of internal medicine residents Integrating research training into residency: tools of human investigation Promoting Translational and Clinical Science: The Critical Role of Medical Schools and Teaching Hospitals A Practical Guide for Health Researchers

• Describe the study research methods and procedures.

Papers Discussing Research Methods

Pick the title and click Go Methodology to improve data quality from chart review in the managed care setting Medical record review conduction model for improving interrater reliability of abstracting medical-related information Chart documentation quality and its relationship to the validity of administrative data discharge records Guidelines were developed for data collection from medical records for use in retrospective analyses Pragmatic strategies that enhance the reliability of data abstracted from medical records Chart review. A need for reappraisal The art and science of chart review Advanced statistics: understanding medical record review (MRR) studies Coding data from child health records: the relationship between interrater agreement and interpretive burden Methods to achieve high interrater reliability in data collection from primary care medical records Definition, structure, content, use and impacts of electronic health records: a review of the research literature Quality control in multicentric clinical trials. An experience of the EORTC Gynecological Cancer Cooperative Group Comparison of information content of structured and narrative text data sources on the example of medication intensification Ensuring high accuracy of data abstracted from patient charts: the use of a standardized medical record as a training tool A Framework for Capturing Clinical Data Sets from Computerized Sources Measuring diagnoses: ICD code accuracy ICES Report: Using Data from Electronic Medical Records: Theory versus Practice Data Quality of General Practice Electronic Health Records: The Impact of a Program of Assessments, Feedback, and Training Using your electronic medical record for research: a primer for avoiding pitfalls How to Document a Data Collection

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.

• Briefly describe the resources (study personnel and facilities) required for the conduct of this study and address whether they are sufficient for the conduct this study.

Pick the title and click Go Methodology to improve data quality from chart review in the managed care setting Medical record review conduction model for improving interrater reliability of abstracting medical-related information Chart documentation quality and its relationship to the validity of administrative data discharge records Guidelines were developed for data collection from medical records for use in retrospective analyses Pragmatic strategies that enhance the reliability of data abstracted from medical records Chart review. A need for reappraisal The art and science of chart review Advanced statistics: understanding medical record review (MRR) studies Coding data from child health records: the relationship between interrater agreement and interpretive burden Methods to achieve high interrater reliability in data collection from primary care medical records Definition, structure, content, use and impacts of electronic health records: a review of the research literature Ensuring high accuracy of data abstracted from patient charts: the use of a standardized medical record as a training tool ICES Report: Using Data from Electronic Medical Records: Theory versus Practice Data Quality of General Practice Electronic Health Records: The Impact of a Program of Assessments, Feedback, and Training Using your electronic medical record for research: a primer for avoiding pitfalls

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

Waiver of Informed Consent Guidance

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:

• Not everything is in the EHR,
• Not all follow-up care is listed.
• Images from radiology may not be there.

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

• Check your CTSA site for additional assistance.

• Specific Site Information: Davis List of Clinical Trials Training Programs

• Browse Educational Course Materials.
  • During Year 1, you will focus on data types and study types.

• Browse Articles or Content of Interest and Clinical Research Vocabulary to familiarize yourself with clinical research terms.

• Hamann - A Short Outline of Year 1 Residency Project Preparations

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.

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Topic revision: 16 Aug 2012, MaryBanach

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