ICH E6(R3) Annex 2 readiness assessment
Annex 2 of ICH E6(R3) covers decentralised elements and pragmatic trials and takes effect in the European Union on 15 January 2027.
Annex 2 of ICH E6(R3) covers decentralised elements and pragmatic trials and takes effect in the European Union on 15 January 2027. Sponsors and academic trial units running remote or hybrid elements will need to show how their data flows meet it.
The assessment is a fixed-scope review of a study's remote data flows against Annex 2 expectations, delivered as a written report with a gap list.
The platform itself is designed for Annex 2 requirements: data collected at home carries provenance, identity assurance, a signal-confidence score and an audit trail, and sits alongside the sponsor's existing EDC.
Price
CHF 4,500
Credited in full against a platform contract signed within six months.
Deliverable
Written report with a gap list.
Scope
One study's remote data flows, reviewed against Annex 2 expectations.
Questions and answers
ICH E6(R3) Annex 2 questions
What is Annex 2 of ICH E6(R3)?
Annex 2 of the ICH E6(R3) Good Clinical Practice guideline covers decentralised elements and pragmatic trials. It takes effect in the European Union on 15 January 2027.
Who needs to prepare for Annex 2?
Sponsors and academic trial units running remote or hybrid elements, such as home-collected patient-reported outcomes, wearable data or remote consent, will need to show how their data flows meet Annex 2 expectations.
What does the readiness assessment deliver?
A fixed-scope review of one study's remote data flows against Annex 2 expectations, delivered as a written report with a gap list.
How much does the assessment cost?
CHF 4,500, excluding VAT. The fee is credited in full against a platform contract signed within six months.
Is the Vitruvian Shield platform Annex 2 compliant?
The platform is designed for Annex 2 requirements: data collected at home carries provenance, identity assurance, a signal-confidence score and an audit trail, and sits alongside the sponsor's existing EDC. This is a design statement, not a compliance claim; the validation dossier is planned.
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