Overview
The Regulatory Core of the AXIS Grant has four major functions:
a) to help to establish a Technology Transfer/Intellectual Property Office;
b) monitoring research studies by a Research Subject Advocate to ensure subject safety from a regulatory perspective;
c) to facilitate the administrative aspects of setting up research studies at Charles R. Drew University; and
d) to house and support a Data Safety Monitoring Board.
This new Intellectual Property/Technology Transfer Office will be dedicated to identifying research that has potential commercial interest and strategies for how to exploit it. The Research Subject Advocate will review ongoing research studies to ensure patient safety and identify potential regulatory issues that if not corrected and were to be discovered by an external audit might compromise continuation of the study. Common forms will be developed to help lessen the repetition of filling out separate ones for each required committee approval.