Draft model for gap metadata

[swhume]

Some have expressed an interest in creating a draft model for the gap or study-specific metadata needed to complete the generation of a full Define-XML specification. Assuming we agree to do this, this task is to generate a draft model and schema for the gap/study-specific metadata.

[swhume]

Could we use USDM extensions? Maybe create a targeted extension. We may need to generate a spreadsheet to use as a UI.

Ensure alignment with CRF generation.

[swhume]

@dostiep @mikemolter Here's a thought from our Define-XML discussion last week regarding the need to refine the Define-XML specification. At the moment, I think we've identified 3 types of content for this gap metadata model:

1. To provide the metadata to swap out for the PLACEHOLDERs in the dds.json (aka define.json)
2. To provide metadata that overrides existing content. In this case, there is no placeholder, so the dds.json contains a valid value, but we opt to replace it with one that's more accurate for this study.
3. To extend the dds.json with new content needed for the study. Dictionaries such as MedDRA and WHODrug might fall into this category. Additional datasets or variables that were not available when the initial dds.json was created but are needed for the study also fall into this category.

[dostiep]

@swhume @mikemolter I agree with the items listed above. I have a question though: why would we need a new model whereas we already have the DDS model? Can't we re-use the DDS model to address the gaps and add study specific metadata?

I had a chat with Claude that agrees with me that we rather need a GUI to compute/update information rather than a new model.

[swhume]

@dostiep @mikemolter A new model is mostly part of a test scaffold that simulates pulling data from external sources. It allows us to demonstrate the DDS refinement process. It's not intended to be a new standard. With that in mind, it should be simple to create. We just need something to show the refinement process in our upcoming demos.

Beyond what we need to run a demo and show the refinement process in action, a DDS editor would be a great addition. So, I agree that it would be great to have an editor (GUI), but that seems like another project or feature team. I created issue #126 as a placeholder for developing a DDS editor in our backlog.

[mikemolter]

I agree that a nice GUI would be nice, but do we consider a P21-like spreadsheet for the shorter term? Not my favorite solution but it might be enough to, as Sam says, show the refinement process.

[swhume]

Given that an editor would be ideal, if we have a small, simple model, we should be able to generate a spreadsheet for data entry. Not a long-term answer, but something we could use to allow folks to play with the DDE and the refinement process until an editor is available.

[dostiep]

@swhume @mikemolter would a DDS-lite model be enough to cover the refinement process?

[swhume]

I think so. We're just demoing the refinement process, so it's more of a POC. Any model that works is good enough, so a DDS-lite model seems sensible.

[swhume]

@dostiep do you have a DDS-lite model for the patch file? If not, I'll close this one as it's not critical for the demo. If you have it, please create a PR and we'll add it to the repo.