Syllabus - Winter 2009

CLASS 1:

PPT1: Introduction

PPT 2: Human Subjects

PPT3: Protocol

Handout 1: HSD Exemption Example

Handout 2: HSD Expedited Review Example

Handout 3: GEMS Study Protocol

NOTICE: EPI 587 HAS BEEN CANCELLED FOR WINTER QUARTER. It will be offered again during Fall quarter 2009. Please contact Annette Fitzpatrick (fitzpal@u.washington.edu) if you have any questions.

COURSE DESCRIPTION:

This two credit seminar course is offered to provide the pragmatic aspects of doing clinical research, primarily covering the day-to-day operations of conducting a study. The course will consist of 7 two-hour seminar style lectures. The final session will consist of student presentations. Lectures are conducted by faculty from the Departments of Epidemiology with guest lecturers from other departments in the University.

The course will cover all of the basics necessary to plan and implement a research study. Topics include human subjects and Institutional Review Board application, data collection methods, hiring and training of staff, participant recruitment, follow-up and retention, data management, quality assurance and control, results reporting, study monitoring and communications, and budgeting. A research plan will be developed over the course of the seminar and the class will culminate in student presentations.

NOTE: Due to two holidays occurring on Mondays over Winter Quarter, there will only be 7 lectures.

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CLASS 1 - 09-27-07: Introduction and Human SubjectsTopics: Collection of information on students' backgrounds; review of topics that will be covered here and the topics that will not be covered; brief explanation of some epidemiologic terms that students should be familiar with. Applying for IRB approval will be covered in the second hour of the class.

.Required Reading (All): Chapter 14, Hulley and Cummings: Addressing Ethical Issues

Assignments (All): Complete the Human Subjects regulations online courses offered by CITI; HIPAA certification is optional (please see instructor for password)

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CLASS 2 - 10-04-07: Protocol Development and Choosing Study Instruments Topics: Review different types of studies and implications for protocol development including specific components of a protocol; pros and cons of different types of data collection including cost and participant burden; choosing a study instrument (forms and questionnaires); tips for developing your own questionnaire.

We'll be moving upstairs (HS Labrary Classroom A) for a demonstration of a computer application to help investigators find standardized questionnaires and insturments ona variety of topics. Joanne Rich, Information Management Librarian in the Health Sciences Library, will present a tutorial called "Finding Measurement Tools" which she helped develop. The module is located at:

http://healthlinks.washington.edu/howto/measurement/

Required Reading (All): Chapter 15, Hulley and Cummings: Designing Questionnaires and Data Collection Instruments

AND The Ginkgo Evaluation of Memory (GEM) Study Protocol (provided in Handouts section of this website).

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CLASS 3 - 10-11-07: Personnel: Hiring, Training and Collecting Data. Topics: We will review issues on hiring staff including qualifications for different jobs and the general process of hiring staff/firing. Different UW job classifications for specific duties will be addressed. How to train staff and implement the study, covering interviewing and study procedures will be a focus of this class as well.

Guest Speaker Kris Wicklund is a Senior Staff Scientist at the Fred Hutchinson Cancer Research Center in the Cancer Epidemiology Research Cooperative (Public Health Sciences), kwicklun@fhcrc.org . She will talk about implementing questionnaires and using study forms focusing on training of interviewers and administration of instruments. Kris manages a data collection and interviewing group at the Hutch.

Required Reading: Chapter 4."Staffing your Laboratory" in Making the Right Moves: A Practical Guide to Scientific Management for Postdocs and New Faculty. Burroughs Wellcome Fund, Howard Hughes Medical Institute (posted in Handouts section of this site).

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CLASS 4 - 10-18-07: Recruitment and Retention of Study Participants. Topics: We will review strategies related to recruiting and retaining participants in your study. Issues including approaches to recruitment, monitoring your goals, when to modify the protocol, and issues related to publishing articles on recruitment and retention will be covered.

Guest Speaker Denise Sharify is the Health Coordinator at Neighborhood House, a social service agency working with multi-ethic communities in Seattle. She'll discuss issues related to community outreach and recruiting minorities into studies.

Required Reading: Chapter 3, Hulley and Cummings: Choosing the Study Subjects, Specification, Sampling and Recruitment.

Fitzpatrick AL, et al., Recruitment of the Elderly into a Pharmacologic Prevention Trial: The Ginkgo Evaluation of Memory Study Experience (provided in Handouts section of this site).

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CLASS 5- 10-25-07: Data Entry and Management Topics: In this class we will cover principles of data entry and data management. Different approaches and tools that may be used will be considered. A systems approach for organizing and managing data will be demonstrated by Fumei Lin, Senior Systems Analyst and Programmer for the Collaborative Health Studies Coordinating Center in the Department of Biostatistics.

Required Reading: Chapter 16, Hulley and Cummings: Data Management

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CLASS 6- 11-01-07: Quality Control and Assurance Topics: This class reviews methods for assuring the data quality of your study. Actual methods and procedures to produce accurate data will be presented. Alice Birnbaum of Axio Research will present the lecture. She'll also provide insights on using an outside contractor for doing pieces of your research.

Required Reading:Chapter 17, Hulley and Cummings: Implementing the Study: Pretesting, Quality Control and Protocol Revisions.

2nd Reading: Gassman JJ, et al. Data Quality Assurance, Monitoring and Reporting, CCT 1995; 16:104S-136S.

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CLASS 8- 11-15-07: Communications and Project Management Topics: This class will review methods of communications to be used for the public, study participants/patients, co-investigators and staff. Use of the webpage to enhance communications will be discussed.

Required Reading: Chapter 5. "Undertaking the Project" in Usherwood T, Introduction to Project Management in Health Research: A guide for new researchers .

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CLASS 9- 11-29-07: Budgets This class will review the different items that should be considered for including in a project budget and tips for calculating what you'll need. An actual budget will be built in class using a template you can modify for your own grants.

Required Reading: Peruse the rules and regulations associated with budgeting for federal grants documented in the A21 Circular: http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html