What problem does it solve?
This Skill helps researchers rapidly produce the full Chapter 11 annex package required for scientific research submissions to ethics committees, reducing manual drafting effort and improving consistency across consent forms, collection instruments, institutional authorizations, and responsibility statements.
Core Features & Use Cases
- Full Annex Generation: Drafts all ten required annexes, including TCLE, data collection form, individual data table, Lattes URLs, conflict-of-interest declarations, institutional authorization, and responsibility terms.
- Ethics-Ready Formatting: Applies CEP-focused structure and legal compliance text for Brazilian research submissions, including specific handling for observational studies and clinical trials.
- Reference-Driven Documents: Pulls fixed text from the bundled reference model to ensure consistent wording for consent withdrawal, confidentiality, privacy, access rights, and other mandatory clauses.
Quick Start
Provide the research title, study type, team details, institutional data, and any known participant, risk, benefit, and conflict-of-interest information so the Skill can generate the complete Chapter 11 annex set.