2015 ASPIRE Module: Introduction to Principles and Practice of Clinical Research (IPPCR)
The ASPIRE Modules are short, non-credit bearing electives that broaden the training experiences of biomedical sciences trainees. These elective modules provide efficient exposure to topics in three theme areas: Business/Entrepreneurship, Communication, and Clinical research.The ASPIRE Modules are optional and open to any biomedical sciences PhD student or postdoctoral fellow who wishes to take them to supplement their research training. Class size may be limited, however, and will vary by module.
Module Title: Introduction to the Principles and Practice of Clinical Research (IPPCR)
Director: NIH Clinical Center
Time: Classes will run Monday and Tuesday nights from 4-5:30pm central time from October 13, 2015 – March 22, 2016.
Vanderbilt will be participating as both a live webcast AND archived material remote site. Therefore, as long as you have registered through the NIH Clinical Center Site, you will be able to use your email and password to access all archived lectures online within 24-48 hours of the webcast.
There is an optional, on-line final exam given at the end of the course and a certificate of successful completion is awarded by the NIH to those who pass the final exam with a score of 75% or higher.
Registration requirements: none
Registration deadline: August 21, 2015
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Syllabus
Session I: Study Design and Statistics
Duration: eleven 1.5 hours sessions
Content: Study development, clinical trials design, measurement, analyzing and presenting data
Session II: Ethical, Legal, and Regulatory Considerations
Duration: seven 1.5 hours sessions
Content: Ethical principles, legal issues, FDA product regulation, inclusion of women and children, IRBs
Session III: Preparing and Monitoring Clinical Studies
Duration: twelve 1.5 hours sessions
Content: Data management, protocol mechanics, NIH review, SOPs, project management, case study report forms
Session IV: Miscellaneous Topics
Duration: seven 1.5 hours sessions
Content: Technology transfer, scientific conduct, health disparities research, team science, disseminating results
Class size: Not limited