DCT System “Live” (Milestone)

The purpose of the DCT System "Live" milestone is to verify that all aspects of the DCT Platform, its associated technologies and services, are ready for use by the trial site, pending regulatory and ethics approval. 

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Description

Decentralized clinical trial (DCT) system go-live is the process of transitioning from a development environment to a production environment.

The process of DCT system go-live can be complex and time-consuming. It involves a number of steps, including:

  • Testing: The system must be thoroughly tested to ensure that it is working properly and that it meets the needs of the trial.
  • Training: All staff involved in the trial must be trained on how to use the system. This includes any trial team members who will be supporting the trial at both traditional and alternative sites, the sponsor and CRO trial team members.
  • Communication: Investigators and their staff, including contracted vendors, must be informed of the go-live date and how the system will work.
  • Monitoring: The system must be monitored after go-live to ensure that it is working properly and that any issues are addressed promptly.

Metrics Considerations

Date of DCT System Live may be important for cycletime KPIs such as time to FPI, LPI.

DCT KPIs