Template · Regulatory Language Infrastructure™
Informed consent translation checklist
The exact six-gate quality workflow we use before an ICF or TCLE leaves our platform for an ANVISA, COFEPRIS, INVIMA, ANMAT, ISP, DIGEMID, ARCSA, or MINSA submission. Print it, drop it into your SOP, or send it to your translator.
Download
Free PDF · English, Spanish, Portuguese
English
For sponsor CMC, clinical operations, and regulatory affairs teams. Permanent versioned page →
Download PDFEspañol (LATAM)
Download PDFPortuguês (Brasil)
Para submissões ANVISA/CONEP com TCLE em português brasileiro. Página versionada permanente →
Download PDFNo email required. Reproduction for internal SOP use is permitted with attribution to Amavita Sciences™.
What's inside
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.
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.
Linguistic quality gates (Six-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.
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.
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.
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.
- Six-Gate QC certificate attached.
Related resources
- Sworn translator affidavit — LATAM reference packCountry-by-country certification format for the 8 major LATAM regulators.
- Glossary of LATAM regulatory translation termsSworn translator, back-translation, apostille, TCLE, and 27 more terms.
- ANVISA translation requirements (Brazil)
- COFEPRIS translation requirements (Mexico)
Want us to run this checklist for you?
Send us your ICF. We'll return a Six-Gate QC'd translation with the certification format your regulator expects. No charge on the first document.