Brazil

DCT Feasibility Assessment Brazil The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Brazil in relation to Decentralized Clinical Trials (“DCTs”). Brazil abides by the regulations set forth by the National Health Surveillance Agency ...

2.1 Name of Regulatory Authority The regulatory body in Brazil responsible for the oversight of clinical trials is the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA) . ANVISA grants permission for clini...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. CONEP requires applicants to submit the following documentation online: Cover Sheet for Rese...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  The following documents must be submitted to ANVISA: Application form for clinical drug...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)? The investigator is the professional responsible for conducting a clinical trial. If the clinical trial is conducted by a group of people, ...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Please refer to Section 2.7 of this guidebook. 6.2 Does local regulation require any separate consent for biological specimen colle...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . There are no regulations preventing the conduct of DCTs. 7.2  I...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   The General Data Protection Law (LGPD) (see below link for English translation) - https://iapp.org/media/pdf/resource...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? Digital advertising and social media advertising are regulated by the same re...

10.1 Clinical Trial with Investigational Medicinal Product 10.2 Pediatric Investigation Plan (PIP) There is no requirement for a PIP in Brazil. 10.3 Clinical Study (Interventional or Observational) Clinical trial applicati...

Clinical Research Regulation (n.d.) Regulatory Fees , National Institute of Allergy and Infectious Diseases (NIAID). Baker McKenzie (n.d.) Clinical Trials Handbook – Americas , Baker McKenzie. Davis S (n.d.) Overview of the Approval of Cl...

Not applicable.