October 11th, 2016: NRDS Status Update

The NRDS Content WG completed their review and recommendations for a set of standardized content to be used for NCTN, ETCTN and Theradex. Below is a list of areas the Content WG provided recommendations for:

• OPEN Demography
• 3 additional OPEN forms
• Adverse Events (integration)
• Serious Adverse Event - integration
• CDUS

The NRDS Policy and Governance WG developed a NRDS Policy and Governance plan around the usage of the recommended standards. The NRDS Policy and Governance Plan includes Principles for the NCTN/ETCTN/Theradex Standards, Roles and Responsibilities, Standards Usage Policies, and a set of Validation Workflows to monitor the use of NRDS Standards.

The NRDS Communication and Training WG developed a set of communication workflows to use throughout the phases of the NRDS Project. As implementation moves forward, they will be working on a training plans.

An impact analysis was done with CTSU, CTIS and Theradex to review the recommended standards and provide feedback on impacts, constraints and risks. This information was then collated and presented to CTEP. CTEP is currently reviewing the recommended standards and impacts and determining which standards provide the most benefit to implement.