amavita

Template · English · v1.0

Informed consent translation checklist (English)

Permanent, versioned reference for the Seven-Gate ICF workflow used before an English-source consent leaves our platform for ANVISA, COFEPRIS, INVIMA, ANMAT, ISP, DIGEMID, ARCSA, or MINSA. This URL is stable across future revisions.

Version v1.0 · Released 2026-07-28 · English

Download · v1.0

Free PDF · English

Download PDFEN · v1.0

Reproduction for internal SOP use is permitted with attribution to Amavita Sciences™.

What's inside

01

Source-document readiness

  • Latest IRB/EC-approved ICF version confirmed with sponsor.
  • Version, protocol code, effective date visible on every page.
  • Track-changes accepted; no residual comments or hidden text.
  • Site-specific inserts marked as [placeholder] instead of hard-coded.
02

Regulatory scope per country

  • ANVISA/CONEP: pt-BR; LGPD alignment; CNS 466/2012 and 510/2016 elements.
  • COFEPRIS: es-MX with 'usted'; NOM-012-SSA3-2012 elements.
  • INVIMA: es-CO; Resolución 8430/1993 elements; certified translation when source is non-Spanish.
  • ANMAT: es-AR rioplatense; Disposición 6677/10; translation by traductor público matriculado.
03

Linguistic quality gates (Seven-Gate QC)

  • Bilingual medical reviewer signs off on terminology.
  • Adversarial back-translation on risks, procedures, and rights sections.
  • Reconciliation report attached; discrepancies resolved and logged.
  • Reading-grade level ≤ 8th grade (or local equivalent) verified.
04

Formatting and layout

  • Same section order and numbering as the source ICF.
  • Signature block matches local requirement.
  • 'Page X of Y' + version + date in footer on every page.
  • Font ≥ 11pt; no scanned images of text.
05

Certification, apostille, notarization

  • Translator declaration: name, credential, date, contact.
  • Sworn/public translator seal where required (BR, AR, CO).
  • Apostille (Hague) attached where the receiving authority requires it.
  • Certificate of Accuracy on sponsor letterhead.
06

Delivery package

  • Searchable PDF + editable DOCX per language.
  • Version-controlled filename: [Protocol]_ICF_[country]_v[X.Y]_[YYYY-MM-DD].
  • Change log vs. previous version.
  • Seven-Gate QC certificate attached.

Other languages

Version history

  • v1.0 · 2026-07-28 — Initial versioned release. Covers 8 LATAM regulators.

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