Step 7 · Compliance

This step holds the participant-facing documents and governance details the trial needs before it can recruit.

What you provide

Consent form

The document participants agree to before taking part. It carries a two-part reference (a trial number and a form version) that must match the participant information sheet.

Participant information sheet (PIS)

The sheet describing the trial to participants, including a trial-specific description paragraph that is separate from the public info-page text.

Document dates and version

The finalisation dates and the shared version number used across the consent form and PIS.

References

The governance references captured in Step 1 · Identity (ethics/protocol reference, and optionally a registry ID) are surfaced here alongside the documents.

Why it matters

Participants see and agree to these documents in the app during consent (see Participants and the trial lifecycle). The consent/PIS version they agreed to is recorded against their enrolment, so you always know which revision each participant saw.

Next: Step 8 · Launch.