Final Application Paper
Choose from one of the following two topic areas:
a) As clinical research activities become more competitive globally, clinical trial conduct continues to grow in countries south of the Equator, Eastern Europe and Asia. Given that the vast majority of highly trained monitors live in Western Europe and North America, what changes can you envision that could transform the manner in which we "monitor" clinical research trials in other parts of the world? As you consider this question, consider aspects of culture and language barriers, business practices and values, and the economics of travel to inform your thinking. What structures of monitoring absolutely must remain in place, and what structures and monitoring processes can be changed to radically transform clinical research monitoring while continue to achieve the overall objectives that monitoring serves.
b) The rapid developments in communications and data technologies, along with the increased calls for an integrated electronic medical record open the door for significant changes to clinical research monitoring within those geographies and locales where such technology exists. Looking at the regulations that guide our thinking about clinical research monitoring and the ICH guidelines, what recommendations would you make to transform the practices of clinical research monitoring from that which we know today. As part of your research and recommendations identify potential barriers and solutions to overcome those barriers. As you finalize your thinking on this topic, identify issues that may require new regulation and propose operational changes to accommodate those new regulations.