Neutrality & governance
A shared safety standard only works if competitors all use it, which means no single company can appear to own it. This is a starting point for discussion, not a settled structure.
Precompetitive consortium
Several sponsors co-fund the work; an independent operator runs it, the model used by TransCelerate and C-Path. No single company owns it.
Independent steering committee
Safety experts, academics, and patient / community representatives set the methods, with published conflict-of-interest disclosures.
Equal treatment
Every sponsor’s data is harmonized the same way. No sponsor sees another’s private data; only pooled, de-identified aggregates are shared.
Funding cap
No single sponsor provides more than ~25% of funding, so no one can buy influence over what the standard says.
Public methods
How terms are mapped and numbers are calculated is published openly, as this resource already does.
Not a regulatory system
Sponsors keep their own legal reporting duties to the FDA and EMA. This is a shared reference, not a replacement for compliance.
Public data first
This resource uses only public aggregate registry data, so none of the participant-level safeguards below are triggered yet. They gate the contribution phase, not this public view.
Before any participant-level data is accepted
- • A security engineer for storage and access control
- • A clinical safety advisor
- • Data-sharing agreements with each contributing sponsor
- • Legal review for HIPAA (US), GDPR (EU), LGPD (Brazil)
Open questions: for the field, not for us alone
- • Does “shared safety data” mean sharing between companies, with regulators, or publicly?
- • Who should operate the standard?
- • For-profit, nonprofit, or public-benefit corporation? Openly-licensed core data protects trust under any structure.