RFC: Safety-data schema for community contributions (good first issue)

[dblizinski]

What this is

A draft RFC (Request for Comments) proposing the minimum set of fields that a research group would need to share with the community safety pool to provide an anonymized adverse-event record. Pooled safety data is core to the open-source thesis; it's what compresses the regulatory timeline from decades to years. A workable schema is the prerequisite that hasn't been built yet.

Why this matters

Without a schema, every research group that wants to share safety data invents its own format, and pooling becomes impossible. With a schema, even a v0.1 pooling becomes mechanical. This is genuinely strategic work; the person who does it will have shaped how the whole community shares safety data going forward.

What to do

1. Comment to claim.
2. Read the linked context (regulatory references, existing standards like CDISC / OHDSI).
3. Draft an RFC with these sections:
   • Motivation: why a community safety-data schema is needed
   • Goals and non-goals: what this schema is and isn't
   • Proposed schema: structured field-by-field spec
   • Anonymization rules: the floor for HIPAA / GDPR alignment
   • Open questions: things you want community input on
   • References: standards consulted
4. Open the RFC as a PR with the title RFC: Safety-data schema v0.1.
5. Comment on this issue when the RFC PR is open so the lane lead can attach reviewers.

Definition of done

• RFC PR opened, structured per the sections above.
• At least one anonymization-rule pass.
• References to existing standards (CDISC, OHDSI, FDA MedWatch as relevant).
• Open questions section actively soliciting community input.
• Named reviewer assigned by the lane lead within one week of PR opening.

Skills

• Research methodology
• Basic data modeling
• IRB / HIPAA / regulatory awareness
• Comfortable writing structured technical proposals

Scope estimate

8–12 hours.

Helpful starting points

• Our regulatory page: https://www.openwater.health/clinical
• CDISC standards: https://www.cdisc.org/standards
• OHDSI common data model: https://www.ohdsi.org/data-standardization/
• FDA MedWatch reporting forms (for field inspiration)

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How to claim this issue

1. Comment "I'd like to work on this." We'll assign it to you.
2. Open a draft RFC PR within ~3 weeks of being assigned.
3. Ask any scoping questions on this issue or in our Discord #contributing channel.

Contact: community@openwater.health

By contributing, you agree to our Contributor License Agreement. (If the CLA isn't yet live when you start, we'll handle it once the flow is up.)