Governance & Compliance
ProNova52 was built for clinical research from day one, which means governance is not a bolt-on — it is part of the data model. Every study captures the references, the consent text, and the audit context your IRB and information governance team will ask for.
Structured governance fields on every study
Public reference (e.g. ISRCTN), internal governance reference, hazard log ID, and data sharing rules each have a dedicated field. This makes regulatory submissions and information-governance reviews painless — every required field is in one place, exportable, and version-stamped.
Consent as a first-class entity
Consent text is editable per-study, presented to participants before any clinical question is asked, and captured with a timestamp that lives on the participant record. Withdrawal is one click and is also audit-logged.
Immutable timeline for every action
Every invite sent, response started, response completed, role granted, and admin action is logged to an append-only timeline scoped to the organisation. Filter by participant, user, action type, or date range when investigating a query from a sponsor or regulator.
Capabilities
- Public reference, governance reference, hazard log fields
- Editable, per-study GDPR-compliant consent text
- Timestamped consent capture and withdrawal
- Append-only timeline scoped to organisation
- Per-action metadata (who, what, when, where)
- Researcher-role PII redaction for blinded review
- Multi-tenant RLS enforced at the database level
Typical use cases
- MHRA / IRB submission packs
- Information-governance review evidence
- Sponsor audit response preparation