Describing Patients and Samples (Clinical Data)

Clinical data describes human patients and biological samples. In defining the clinical data portion of the data model, some of the important questions were:

• How do we represent (model) patients and samples collected by the project teams as consistently as possible across different biobanking SOPs?
• What data can be feasibly collected and standardized across each of the project teams given the goals of the consortium?
• What are clinical phenotypes that would be useful to have for more insightful analysis?

Development

The minimal clinical data model was defined with the help of a Request for Comments (RFC) process. The RFC engineering can be reviewed here (opens in a new tab); it helps sets context for what is "minimal" and what others are interested in and why they're interested in certain elements. The current templates (linked in the next section) largely corresponds to that work.
However, it is possible that an extended, richer clinical data model may be later shared based on the decisions of the consortium members and the Program Directors' recommendations.