LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.

ECF Teams and Projects

Digital Health Technologies Governance
Suzanne Bishop (Americas Administrator)
/ Categories: TEAMS, TEAMS STATUS and TYPE, Active, Working Group

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.     

  1. 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

 

Previous Article Audit Trail Review Analytics (ATRA)
Print
28 Rate this article:
No rating