Part One: Before anyone enrolls

Planning is where most registry failures are created, and the planning work is almost entirely conversation and judgment.

Chapters in this part

1. Decide who the data are for. Name the users of the data and let the most important one decide.
2. Start with the analysis plan. Decide the first product, a paper, a trial-ready cohort, or a partnership, and plan the data backward from it.
3. Look at who is already in the space. Amplify an existing effort before building a new one.
4. Decide what to capture before you go looking. Know what the record holds, and ask for the rest.
5. Put a person between the form and the participant. A coordinator participants look forward to hearing from.
6. Know who belongs on the data team. Match the expertise to the question.
7. Settle the protocol, dictionary, and consent before enrollment opens. Governance cannot be added later with AI.