BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
try Platform or the International Committee of Medical Journal Editors, as a condition for authorisation by ANVISA. It is worth noting that public databases in Brazil pro- vide third parties with access to high-level informa- tion on authorised clinical trials (eg, sponsor iden- tification, investigational product/device, general design and recruitment status). However, Brazilian rules are designed to preserve confidentiality and do not require full public disclosure of commercially confidential technical documentation, such as inves- tigational dossiers or complete clinical study reports, which remain protected, including as trade secrets. In parallel, Law No 14,874/2024 requires that the return of research results to participants be addressed (typi- cally through the consent and study communication framework), but broader public dissemination of results is not necessarily uniform and will depend on applicable registry/journal requirements and sponsor publication practices, always subject to confidentiality and personal data protection obligations. Accordingly, while clinical trials are listed in publicly accessible databases in Brazil, public access is typi- cally limited to structured summary information, and the availability of detailed results is partial and regu- lated, rather than automatic or unrestricted. 2.4 Use of Online Tools to Support Clinical Trials Brazilian rules on clinical trials do not create a blanket prohibition on online tools – eg, digital recruitment, eConsent platforms, electronic case report forms (eCRFs), remote visits or remote monitoring. Instead, the permissibility of such tools is assessed under the applicable clinical trial framework for medicines and medical devices, and they must be implemented in a way that preserves participant protection, data integ- rity and regulatory inspection capability. In practice, online tools used for recruitment, such as social media ads, online prescreening forms, landing pages etc, are treated as participant-facing materi- als and processes, and as such, must be consistent with the approved clinical trial documentation and the applicable ethics requirements overseen by the CEP system and, where applicable, CONEP, including
proper informed consent processes and safeguards against undue influence and misleading information. For monitoring and conduct, such as remote source data verification, telemedicine visits, wearable data capture, decentralised procedures, etc, online tools remain acceptable where they are appropriately described in the protocol and supporting documents, and where the sponsor and investigator ensure con- fidentiality and controlled access, auditability and traceability (including for electronic records), and readiness for inspection and oversight by the compe- tent authorities within the applicable ANVISA clinical trial framework for medicines and medical devices. 2.5 Use of Data From Clinical Trials Data processing in the context of clinical research in Brazil must comply both with data protection rules, and with the ethical and regulatory standards appli- cable to human-subject research. In practice, clinical trial datasets will generally qualify as personal data, because they relate to an identified or identifiable par- ticipant, even where the study adopts subject codes and the sponsor/Contract Research Organisation (CRO) does not directly hold the participant’s name. Moreover, in most cases such datasets will qualify as sensitive personal data, because clinical trials inher- ently generate and analyse health-related informa- tion, which is expressly protected as sensitive data under Article 5, II of the Brazilian GDPR ( Lei Geral de Proteção de Dados – LGPD). Depending on the protocol and endpoints, datasets may also include genetic and/or biometric information, which typi- cally demands heightened governance, security and access controls. It is important to highlight that if the dataset is prop- erly anonymised, meaning participants are no longer identifiable by reasonable means, it is not treated as personal data for LGPD purposes. However, fully irreversible anonymisation is often impracticable dur- ing trial conduct, because sponsors and regulators may require traceability for monitoring, audits, safety follow-up, data integrity checks and inspection readi- ness. For that reason, most operational datasets are maintained in a coded/pseudonymised form, with strict controls over who can access the re-identifica- tion key and under what conditions.
37 CHAMBERS.COM
Powered by FlippingBook