Posted by piperlt on Monday, November 9, 2015 in Progress Report.

Progress Report #2

Since our last report, we have made strides in approaching the IRB process properly. We met with Lynda O’Rear of the Human Research Protection Program. She referred us to Angela Howard, who is Vanderbilt’s device analyst for IRB approval. She was able to give us many valuable insights on what goes into an IRB application, how to achieve an expedited approval, and how to complete other aspects of the approval process, such as CITI training for all key study personnel. We plan to have all of our immediate team members complete CITI training by this Thursday.

Our next steps include contacting and meeting with Vanderbilt Medical Device Regulatory Affairs Program (MDRAP) to discuss the specifics of our design, its production, and the associated risk. This risk assessment is integral for our IRB application, as we must show the device is low risk to obtain expedited approval.

Additionally, we will begin preparing for our oral report with Dr. Walker and start the online IRB application. Lastly, we will begin to research companies from which we may be able to procure pieces for our final design and the associated costs.