Table 1 test

Most clinical papers open their results with a Table 1, the table that describes who was in the study. The rows a researcher, a sponsor, or a regulator expects to see there are the rows your registry has to be able to fill, at a granularity they can use. This page goes with Chapter 1: name the users of your data first, then test your registry against a Table 1 they would recognize.

	Entry
Registry
Condition
Completed by (role)
Date
Version

Users of the data

List the people and organizations who will use your registry's data, and rank them. The most important user decides questions the others disagree on.

Rank	User of the data	What they need from the data	How we know (a conversation, a publication, guidance)

The published paper

Choose a natural history study or registry report in a condition related to yours, from PubMed.

	Entry
Citation (authors, year, journal)
PubMed ID or DOI
Population and number of participants
Why we chose this paper

Row by row

Copy each row of the paper's Table 1, then mark whether your registry could fill it now.

Row in the published Table 1	How the paper measured it	Could we fill it now? (yes, partly, no)	What it would take	Which user needs it

Our own counts

Enrolled, confirmed, and evaluable are different counts. Every report says which one it uses.

Count	Definition we use	Number	As of (export date)
Enrolled
Confirmed (state the tier)
Evaluable for (name the analysis)