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First product and analysis plan

Decide what the registry will produce first, and plan the data backward from it. This page goes with Chapter 2. Name the product, set out what it requires, keep what is central to families next to what researchers need, record the conversations, and keep the analysis plan as a versioned document that grows with the registry. For scoping one analysis once the plan exists, the Data Analysis Request Form asks the question, the decision it feeds, the data, the deadline, and who signs off.

Entry
Registry
Condition
Completed by (role)
Date
Version

Registry identifiers only

Use registry identifiers on this page. Do not enter names, dates of birth, contact details, or anything else that could identify a person.

The first product

Our plan
What the registry will produce first (a descriptive paper, a trial-ready cohort, a data set a partner can evaluate, or something else)
Who will use it
The decision or action it feeds
Target date for the product
If the registry is meant to be broad: the broadest applications it is planned for
What the registry will not try to be

Working backward from the product

List what the product requires, then trace each requirement to the field, the source, and the method that will supply it, and the month by which it has to be in place.

Requirement (population, Table 1 row, outcome, comparison, sample, consent, governance) Field or measure Source and method of collection Standard the field expects (instrument, frequency, who answers) In place by (month)

Two lists, each tied to its user

Measure Central to families and caregivers? (why) Needed by researchers? (who said so) Where it sits (first product, later product, family-facing module) How it will be collected

Researcher conversations

Record what each researcher said they would need to see, what they would be glad to have, and what they would not need. Use roles and institutions rather than names unless the researcher has agreed to be named in the registry's records.

Date Researcher (role, institution) Their question or hypothesis, as they described it What they would need to see What they would be glad to have What they would not need What it changed in the plan

Analysis plan skeleton

One row per question the first product will answer. The missing data strategy for each row is set in the missing data plan.

Question Population and denominator Variables Source and evidence level Analysis Who runs it Reviewed by (role)

Revision log

Date Version What changed Why (which conversation or product) By (role)