Digital Health Technologies Governance

1. Background and Rationale (Clinical Research Challenge)

Wearables, sensors, personal devices are used in data collection for clinical trials - sponsors have limited control and industry standards are needed.  New constructs are required for the governance of their use in clinical trials.  With the rapid adoption in the use of personal devices in clinical trials, the industry must be able to establish a clear scope of responsibilities among all stakeholders.     

2. Objectives

This group will develop standard approaches, processes, expectations - generate minimum standards for us to meet the opinions of global regulators.  Address the problem of generic regulations and create industry guidelines more tangible and actionable.

To... develop standard approaches, practices, expectations - generate minimum standards for us to meet the opinions of global regulators

By... leveraging the experiences and current ePRO best practices and focus on ALCOA compliance

In order to... have a set of guidelines and actions that make the general guidance provided to date more tangible for industry adoption