DDE Targets Three Timeframes

[swhume]

This discussion seeks to clarify the different timeframes, or states, that the DDE solution targets. In 360i, we seek to implement end-to-end standards-driven automation and identify and resolve standards gaps. The DDE solution targets three states: Current, New, and Future; and we are working on all three to various degrees.

1. Current State: Very few organizations have implemented USDM + BCs + DSSs today. To increase the tool's practical utility now, the team decided to support common current workflows, for example, populating the DDS template from existing Define-XML metadata spreadsheets. The Current State is technically not in scope for the 360i program, but it enables the DDE to be used today, and demonstrates the value of DDS as a model that bridges current and future states.

2. New State: This is the main focus of 360i. The sub-team is building an automated pipeline using USDM + BCs + DSSs to generate today's standards outputs (Define-XML v2.1, ODM v1.3.2/v2.0, and current foundational standards). We are not re-thinking everything from first principles here. The goal is to help organizations adopt a new way of working starting from study design by: (a) using a new approach based on USDM + BCs + DSSs, (b) filling metadata gaps in the standards, and (c) maximizing automation of the metadata generation pipelines.

3. Future State: Standards development is not in the 360i DDE sub-team's remit. However, implementing DDS provides an essential step towards making it a future standard. It also sets the stage for future DDS-based standards, such as a JSON-based version of Define or a Data Transfer Agreement. For those future standards, first-principles thinking may be appropriate and valuable.

The suggestion to work from first principles is valid, but it applies to the Future State, not to all of our work. If organizations adopt DDS via a tool like the DDE, transitioning across states (Current → New → Future) becomes significantly easier.

Please consider whether this three-state framing accurately captures how different tasks fit together, and whether DDS's bridging role is clear. Keep in mind that the New State is the only phase truly in scope for 360i; the Current and Future State work increases the DDE's value today and positions it for the future.

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Bridging the three timeframes using the DDE creates several benefits:

1. It exercises the DDS model - more work using the model to ensure it supports our use cases
2. It should ease the transition from today's way of working to using new approaches like USDM + BCs + DSSs using 1 tool
3. It gets more volunteers engaged, as today's way of working is well known to a larger group
4. It motivates the team, as the companies they represent do not use USDM yet
5. It helps address the metadata gaps identified in Phase 1 (we will likely pull the missing metadata from existing sources)
6. It creates a flexible solution (e.g., companies using MDRs could extend the DDE to pull metadata from the MDR to load the DDS)