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Overview |
Courses |
Instructors |
Advisory Board |
How to Apply
Course Descriptions
The Autumn 2008 program is no longer accepting applications
Single courses may be available
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Next program starts:
Autumn 2009
Details will be posted in Spring
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Program location:
UW campus, Seattle
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The first term provides an introduction to clinical trials, and the following two terms build on that foundation. The work of implementing a clinical trial is explored in the second term. The third term focuses on the organization and management of clinical trials.
Starting this Autumn, certificate courses may be taken for academic credit. Contact a program representative for more information.
Interested in taking a single class? Some courses (designated by a  below) may be open on a space-available basis to professionals who are not seeking the certificate. See Single-Course Enrollment for details.
Autumn Course
Introduction to Clinical Trials
Schedule: UW campus, Seattle. Mondays, 6-9 p.m., Oct. 6 - Dec. 8, 2008; $1008; 3 CEUs.
Instructor: Erica Jonlin
Introduces the major concepts under which clinical trials are designed and run. The themes of ethical treatment of human subjects and Good Clinical Practice (GCP) that are emphasized throughout the program are introduced. Topics:
- Scientific method and study design
- Statistical concepts
- Phases of clinical trials
- The role of the Food and Drug Administration
- Institutional Review Boards
- The Code of Federal Regulations and clinical trials
- Ethical principles, including informed consent and conflict of interest
Winter Course
Implementation and Conduct of Clinical Trials
Schedule: UW campus, Seattle. Mondays, 6-9 p.m., Jan. 5 - Mar. 23, 2009 (no class Jan. 19 and Feb. 16; $1008; 3 CEUs.
Instructor: Dave Hammond
The work of carrying out a clinical trial is the organizing concept for the second course. The complex work of preparing for a study is covered, as well as the myriad details that control its conduct. Topics:
- Preparation for clinical studies
- Participants in a clinical study and their roles (subjects, investigators, sponsors, clinicians, etc.)
- Study initiation
- Ongoing site management
- Statistics and data management
- Study close-out
- Final clinical report
- Sponsor obligations
How to sign up for individual enrollment in this course
Spring Course
Project Management and the Business of Clinical Trials
Schedule: UW campus, Seattle. Mondays, 6-9 p.m., April 6 - June 15, 2009 (no class May 25); $1008; 3 CEUs.
Instructors: David Hammond and Eric Hayashi
Clinical trials involve a large number of tasks and people responsible for parts of the overall study. The relationships among these parties require understanding and careful management in a successful study. Clinical trials have a business dimension that includes principles of project management, planning, analysis, contingency and follow-up. Topics:
- Management of Clinical Trials
- Managing relationships among clinical trials constituencies (CRC's, CRA's, investigators, subjects, staff, IRB's, sponsors, etc.)
- Management of people at work
- Public relations and current topics
- Business of Clinical Trials
- Overall investigational plan, including budgets and timelines
- Quantifying business decisions and basic financial analysis tools
- Site negotiations in single and multi-site trials
- Outsourcing and Contract Research Organizations (CRO's)
- The art of negotiations
- Developing strategic partnerships
This course may include a field trip to a company or trials site on an evening to be announced. Students will drive or carpool to the site.
How to sign up for individual enrollment in this course
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