7. Decentralized Clinical Trials

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 Is there any specific regulation/guidance on the use of DCT elements within a clinical trial?

There is no specific guidance available for the use of DCT elements in a trial.

7.3 What is the overall acceptability of DCT elements by the Regulatory Authorities and Ethics Committees?

While there is no specific guidance on DCT elements or a DCT trial, there is evidence that these elements are being used in clinical trials in Brazil and, therefore, that they are generally accepted in clinical trials.

7.4 Has a fully virtual trial (DCT) been conducted in the country yet? If so, please provide an example including the registration number and any link to it, whether COVID/non-COVID trials.

No, there is no evidence that a fully decentralized trial has been conducted yet in Brazil. There is, however, evidence of the use of decentralization in studies, particularly during the COVID-19 pandemic. 

7.5 Are there any non-regulatory DCT initiatives in the country, such as where the investigator sites and local CROs founded an alliance?

No.

7.6 Are there any general considerations when using DCT elements in a study?

No.

7.7 Considerations/Requirements for the Use of eConsent/Remote Consent

Yes. Since the COVID-19 pandemic, electronic consent forms have been used in clinical research. This is likely to continue into the future.

7.8 Considerations/Requirements for the Use of eSignatures

In Brazil, the use of electronic and certificate-based digital signatures is evolving and their acceptance in the business community and by public entities is increasing. Recently, this process has accelerated, and more laws and provisional measures have been issued regarding the use of electronic or digital signatures, and more businesses, governmental bodies, and entities have started using and accepting electronically or digitally signed documents. However, it should be emphasized that no one can be obliged to contract electronically in Brazil, and the option for a handwritten signature should always be available.

The main laws and regulations that govern the use of electronic signatures and digital signatures in Brazil include:

1. The Brazilian Civil Code: Article 104, III of the Brazilian Civil Code establishes the freedom of contract forms, meaning that a legal agreement is valid if it is in a form either prescribed by law or not explicitly prohibited by law.
2. The Provisional Executive Act 2.200-2 (“MP 2200”): The Provisional Executive Act of August 24, 2001, provides for the validity of general electronic agreements signed with a digital signature.

Per the Brazilian Civil Code, an electronically signed agreement must have a:

1. capable agent;
2. licit, possible and determined or determinable object; and
3. form that is prescribed or not prohibited by law.

Brazil maintains its own public key infrastructure (PKI) for digital certificates called “Infraestrutura de Chaves Públicas Brasileira” (ICP-Brasil). The authorized PKI-Brazil certifying authorities can be found here: https://estrutura.iti.gov.br/. MP 2200 guarantees the legal validity of digitally signed documents in the following situations: 

1. documents produced within ICP-Brasil; and
2. documents produced outside ICP-Brasil, if minimum parameters for evidencing the authorship and integrity are met. 

For documents produced outside ICP-Brasil, the validity parameters of authorship and integrity are met when: (1) proof of the signer identification is provided; and (2) proof of the integrity of the signed document is provided, subject to the acceptance of the authentication method by all parties that are signing the document.

Electronic signatures that comply with the Brazilian Civil Code and MP 2200 are considered to have the same legal effect as a handwritten signature. Additionally, digital signatures backed by ICP-Brasil are granted a legal presumption that the signature belongs to the person who signed and that the content of the electronic document remains unchanged. In contrast, electronic signatures created outside of ICP-Brasil do not carry this legal presumption and the authorship and integrity of the document might need to be proven.

7.9 Considerations/Requirements for Electronic Patient Reported Outcome (ePRO)

There is no specific guidance on this matter. 

7.10 Considerations/Requirements for Home Health Care (HHC)- Home Nursing

In Brazil, the organization of home health care is in its early stages, in both the public and private health systems. Therefore, there are no specific regulations regarding HHC in Brazil. 

7.11 Considerations/Requirements for HHC - Home Lab Collection

There are no specific guidelines regarding Home Lab Collection in Brazil.

7.12 Considerations/Requirements for Direct-to-Patient Study Product Delivery

There are no specific guidelines regarding DTP study product delivery.

7.13 Considerations/Requirements for the Use of Telemedicine

Regulatory authorities and other bodies of the Government are issuing rules to allow the effective practice of telemedicine. However, despite these regulations, the Brazilian framework on telemedicine still lacks a law generally validating the practice. It is expected that the authorities will work together to establish rules to provide a consistent framework, capable of allowing the effective use of telemedicine on routine patient consultations.

There are no rules regarding the use of telemedicine for clinical trials. 

The Bill of Law No. 1998 of 2020, as approved by the House of Representatives, provides for general rules for telehealth, among which are the following:

• The patient and the healthcare professional are allowed to decide whether the healthcare assistance will be made remotely or physically.
• If the healthcare professional understands that the remote assistance may threaten the correct diagnosis or treatment of the patient, a physical examination shall be required.
• Telehealth is authorized except where it can be demonstrated that physical assistance is required in the best interest of the patient.
• Companies that provide, or act as intermediaries for, telemedicine services must be registered with the physicians’ council where the company is established.
• Healthcare operators are allowed to supply telehealth services to their beneficiaries if physicians are equally compensated for remote or in-person services.
• The physician who provides remote healthcare assistance must be registered with the local professional council. It is not required to be registered in all jurisdictions where the trial is being conducted. 

7.14 Considerations/Requirements for the Use of Wearables

Depending on the purpose of wearables, they may be classified as medical devices subject to regulation and supervision by ANVISA.

7.15 Considerations/Requirements for Remote Monitoring

There are no specific regulations around remote assessment.

Remote Monitoring (RM) is still underutilized in Brazil. Despite having a favorable report, Brazilian regulatory agencies have not included RM in public or private networks. However, it has been used by some private centers and in research projects.

7.16 Considerations/Requirements for Digital Health Technologies (such as Platforms)

Post Covid has seen Brazil’s digital healthcare platforms grow rapidly and projections see further growth in the next few years. The digital healthcare landscape is constantly changing and, therefore, the use of digital technologies in clinical trials would be approved on a case-by-case basis until legislation is implemented.