Housekeeping — Horiana Annex I package (CLOSED)

Status (2026-04-21): Closed. All four Horiana review-panel members (Céline Fabre, Antoine Giraud, Coralie Cantarel, Fabienne Diaz) now have both a CV and a signed Declaration of Potential Conflict of Interest attached to Annex I. No residual housekeeping. This note is retained as an audit trail of how Option A of task-3b15 was completed.

Final state

The Annex I package of both the Clinical Evaluation Plan (R-TF-015-001) and the Clinical Evaluation Report (R-TF-015-003) now contains, for each of the four Horiana panel members:

• A Docusaurus-rendered CV (CV_Celine-Fabre.mdx, CV_Antoine-Giraud.mdx, CV_Coralie-Cantarel.mdx, CV_Fabienne-Diaz.mdx).
• The original Horiana CV PDF (HORIANA_CV 2026_Céline FABRE.pdf and equivalents for the other three).
• A signed Declaration of Potential Conflict of Interest PDF (Declaration of Interests-Céline Fabre _ QMS.pdf and equivalents).

All files live in apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Evaluation/Appendix/. They were added in commit ae53a12e6 by Jordi Barrachina on 2026-04-21.

Audit-visible prose is now aligned

The Annex I claim in the ### External methodological review subsection of both the CEP and the CER is now factually supported:

"The CVs and signed Declarations of Potential Conflict of Interest of the Horiana review team (Céline Fabre, Antoine Giraud, Coralie Cantarel and Fabienne Diaz) are provided in Annex I."

The audit-visible prose does not reference any pending status, because nothing is pending.

How the task was closed in the end

What shipped is wider than the do-we-need-this.md recommended scope of "Option A = add Céline only":

• Named participants: four (Céline Fabre plus Antoine Giraud, Coralie Cantarel, Fabienne Diaz), not one.
• Regulatory framing: Céline Fabre is named as Head of Biostatistics, Horiana; the other three as biostatisticians, Horiana. The role language in the DOI files — Independent Methodological & Statistical Consultant — is retained as the formal engagement basis.
• Scope-narrowing sentence added to both CEP and CER: "The competence footprint of the Horiana team is biostatistical and methodological; clinical-content appraisal (including Valid Clinical Association for dermatological conditions and the overall benefit-risk assessment) remains exclusively with the named evaluation team." This sentence matters: it prevents any reading under which the Horiana panel shares benefit-risk-assessment responsibility with the internal team.
• Internal four-member competence matrix (CER §Qualification): unchanged. The Horiana four are framed as a distinct external biostatistical/methodological panel, not as columns on the internal clinical-evaluation-team matrix. This is a sharper regulatory framing than adding them to the matrix — they are not clinical evaluators at Antonio's level, and the §6.4 four-competence coverage of the internal team stands on the internal four alone.
• Option D-lite structured subspecialty-coverage table (task-3b11 output, CEP §Subject Matter Expert coverage and CER mirror): unchanged. That table remains the answer to subspecialty-breadth concerns; the Horiana panel addition is orthogonal.

Guardrails that were honoured

• Do not promise Annex I content that is not present → honoured. The Annex I sentence was only added once Jordi committed the CV and DOI files (commit ae53a12e6).
• Do not re-introduce Constanza Balboni or Maria Belen Hirigoity → honoured. The removal decision stands.
• Do not frame the Horiana panel as clinical evaluators / case-level adjudicators → honoured. The biostatistical-and-methodological scope-narrowing sentence makes this explicit.
• Do not cite internal paths, task IDs, or bsi-non-conformities/ anywhere in the CEP/CER → honoured. The audit-visible text cites only regulatory instruments (MDCG 2020-1, MDCG 2020-6 Appendix III, MEDDEV 2.7/1 Rev 4) and audit-visible records (R-TF-015-006, R-TF-015-012).

Ownership (for the audit trail)

• Jordi Barrachina collected the CVs and DOIs from Horiana and committed them to Appendix/ on 2026-04-21 (commit ae53a12e6), together with the CEP and CER paragraph updates naming all four panel members and declaring the biostatistical scope.
• Taig Mac Carthy, in the preceding working session, inserted the initial ### External methodological review subsection into both the CEP and the CER (commits a78a3e140 and 0f60ab775), applied the scope-boundary fix raised by the celine-clinical-consultant reviewer agent, closed Options B / C / D on regulatory grounds, and updated the bsi-clinical-auditor agent definition to stop generating the overclaiming subspecialty-consultant finding.
• Saray Ugidos is the internal point of contact for the Horiana relationship per the 2026-04-17 email thread.