Overcoming Challenges to Ensure Consistent, Reliable Data Collection Methods
What is This Initiative?
This initiative aims to recommend universal standards for remote data collection in clinical trials, regardless of the method used. By meeting specific thresholds and criteria, these standards will help reduce barriers related to data collection methods and ease the burden on ethics and regulatory agencies. The challenges to address include verification, validation, justification, and usability of remote data collection methods. This, in turn, will increase the confidence of sponsors and regulators in the data collected and support DCT adoption.
To define different remote data collection methods and establish dynamic criteria for the adoption of evolving technologies; identify a third party to help regulate data collection processes related to decentralized clinical trials (DCT); and develop a framework for the successful adoption of these standards by vendors providing data collection tools.