Standards Development Facilitation

Client Profile: Government Agency

Client Need: Project management and stakeholder facilitation for the development of a set of standards to used across clinical trials

Essex Results: The creation of a consensus-based data standards repository with a set of data elements in the last round of curation.


Our client was working on the creation of a data standards repository that identifies the core data collection and analysis points for a clinical trial. The repository includes a standards portal that allows easy access for clinicians and investigators to gather critical data elements for their trials. Challenges included facilitating a large, broad, and geographically-dispersed group of stakeholders, and coming up with an approach that will make access and implementation of the standards user friendly.

The Essex Team stepped in to take over from resources who had not been effective in this role to facilitate and manage this project. The team first developed a project recovery plan, and has been working to focus the teams on defining and documenting their clinical needs, determining what should be standardized, and coming to consensus on the easiest way for clinicians and researchers to find, use, and report use of the agreed-upon data elements.

The project is currently in the final stages of curation for the last round of data elements. Because of the success of this project, additional projects have been identified for collaboration around and inclusion of additional types of data elements. The Essex team continues to manage these projects, and will do so through to completion.