Scenario walk-through

Walk each likely scenario to its conclusion before enrollment opens, and record what it would require of you. This page goes with Chapter 7. For each scenario, the questions are the same: what data you would need to have collected, at what granularity, who you would need to share them with, and what consent and identifiers that would take. The answers are concrete enough to take to a partner.

	Entry
Registry
Condition
Completed by (role)
Date
Version

An industry partner brings a treatment to the FDA in five years

	What it would require
Data we would need to have collected
At what granularity
Who we would need to share it with
Consent and permissions it would take
Identifiers and linkage it would take
What we have now
Who we would ask to check this

A drug approved for a related condition is repurposed for ours

	What it would require
Data we would need to have collected
At what granularity
Who we would need to share it with
Consent and permissions it would take
Identifiers and linkage it would take
What we have now
Who we would ask to check this

A trial needs a new outcome measure to be feasible

	What it would require
Data we would need to have collected
At what granularity
Who we would need to share it with
Consent and permissions it would take
Identifiers and linkage it would take
What we have now
Who we would ask to check this

We educate teachers, therapists, and health systems about our community

	What it would require
Data we would need to have collected
At what granularity
Who we would need to share it with
Consent and permissions it would take
Identifiers and linkage it would take
What we have now
Who we would ask to check this

A scenario of our own

	What it would require
Data we would need to have collected
At what granularity
Who we would need to share it with
Consent and permissions it would take
Identifiers and linkage it would take
What we have now
Who we would ask to check this