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ISBLD Framework Seal

A quality signal.
Not a shortcut.

The Seal is being built as a transparent review pathway for appropriate study sites, clinical partners and future Society products. It will communicate what has been reviewed — and equally clearly what it does not guarantee.

🛡 Current status

Criteria and review pathway in development.

No participant, site, product or programme is currently listed as Seal-reviewed through this pathway.

It can mean

Published criteria, documented review and a defined scope.

It cannot mean

Regulatory approval, an outcome guarantee or an individual medical recommendation.

It is never

A paid endorsement, a substitute for local law or a promise of commercial visibility.

The review pathway

Process before
recognition.

The full criteria, application form, reviewer policy and public-register format will be released only when the Council has approved the framework. The stages below show the structure now, rather than claiming a finished certification scheme.

01

Scope & application

A partner or programme describes the setting, intended role, clinical responsibility, data boundaries and relevant jurisdiction.

02

Eligibility review

The Society checks whether the request fits the published scope and whether the required documents, qualifications and declarations are complete.

03

Independent review

Declared conflicts are checked. Reviewers with a conflict step away. The review examines process, boundaries and transparency — not sales volume or visibility.

04

Decision & conditions

Any recognition is documented with its scope, conditions, expiry date and public wording. A seal is never a blanket clinical endorsement.

05

Renewal, learning & withdrawal

Recognition is reassessed; relevant concerns can trigger review, conditions, suspension or withdrawal. Learning returns to the framework.

⚠ Before a Seal is issued

Criteria must be public.
Conflicts must be visible.

The Council will publish the scope, eligibility rules, evidence thresholds where applicable, reviewer and conflict process, duration, renewal logic, register format, complaint route and withdrawal process before accepting Seal applications.

Next Council deliverable

Approve the criteria and publish the Seal framework before B2B promotion starts.