Director: NIH Clinical Center
Time: The course will be entirely self-directed with pre-recorded class sessions available from September 2017- June 2018. The open book exam typically opens around March and remains open for 2 months. The official schedule for this year's program has not been released by the NIH at this time.
- The companion textbook: Principles and Practice of Clinical Research, 3rd Ed. Edited by J. I. Gallin, and F.P. Ognibene is NOT required for participation in the course.
- As a registrant through the NIH Clinical Center site, you will have access to materials online, including handouts, primary literature articles and slide sets provided by the course directors at the NIH. Sign in here: https://ippcr.nihtraining.com/login.php
- Digital Copy of text: Vanderbilt University participants who have a VUnet ID and password will be able to access a digital copy of the text via the Heard library via the following link.
Registration is a 2-step process:
1) Complete an internal registration for the Vanderbilt BRET Career Development office: https://www.surveymonkey.com/r/ModuleIPPCR2017 so that we can send you important updates and information relevant to the course.
2) Register at the NIH Clinical Center
- Please make sure that you complete this step in order to have access to archived lectures, slides/handouts, and other information from the NIH: https://ippcr.nihtraining.com/register.php?remote_site=true
- Select “Vanderbilt University/ BRET” as your remote site.
- Don’t forget your password!
Viewing the lectures:
Here is the link for viewing the course on your own via the archived recordings (there are no live webcasts available). You will need to use the email address you registered with as well as the password you created to login to the NIH course website. You may watch the lectures at any time during the 6 month course.
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. The exam will be made available around Feb 2018, and will remain open until the end of the class date, June 15, 2018
From the IPPCR website “The final examination, which is in a multiple choice format, is posted online on the course website the day after the last lecture and remains available for 6 weeks. Once you electronically submit your answers, your exam is instantly graded and you will receive your score. If you passed the exam with a score of 75% or higher, a link will appear for you to save and print a PDF version of your certificate of completion.
The exam is about 50 to 60 questions. You may open the electronic exam, print it out, take your time answering the questions on paper, and then go back into the online exam and submit your answers. It should take appx. 90 minutes to complete.
Course Content: (will be updated when 2017-2018 syllabus is released)
Session I: Study Design, Measurement and Statistics (Monday, October 19)
Duration: eleven 1.5 hours sessions
Content: Study development, clinical trials design, measurement, analyzing and presenting data
Session II: Ethical, Legal, Monitoring and Regulatory Considerations (Tuesday, December 15)
Duration: seven 1.5 hours sessions
Content: Ethical principles, legal issues, FDA product regulation, inclusion of women and children, IRBs
Session III: Preparing and Implementing Clinical Studies ( Monday, January 25th)
Duration: twelve 1.5 hours sessions
Content: Data management, protocol mechanics, NIH review, SOPs, project management, case study report forms
Session IV: Additional Study Designs and Miscellaneous Topics (Tuesday, March, 8)
Duration: seven 1.5 hours sessions
Content: Technology transfer, scientific conduct, health disparities research, team science, disseminating results