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.)?

ANMAT is open to the use of decentralized elements in a study. These will be considered on a case-by-case basis by the IRB and EC and should be supported with an appropriate justification and risk assessment. 

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

In July 2023, ANMAT issued a position paper on the inclusion of DCT elements in clinical trials.

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

ANMAT is open to the use of many of the key DCT elements in a clinical trial as long as suitable justification and risk assessments are provided.

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.

There is no evidence that a fully decentralized trial has been conducted in Argentina.

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?

Refer to the ANMAT position paper provided in Section 7.2 above. 

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

According to the ANMAT guidance, handwritten consent must still be obtained. 

7.8 Considerations/Requirements for the Use of eSignatures

As above, eSignatures is a means of recording Informed Consent. 

Electronic Signatures can be used in other aspects of a clinical trial if they comply with the general regulations in Argentina. 

Electronic signatures are regulated in Argentina as follows: 

Applicable Law:

1. Civil and Commercial Code (CCC).
2. Law 25,506, as amended (the Law), on digital signatures.
3. Decree N° 182/2019 as amended, regulation of the Law.
4. Decree N° 892/2017 regulating digital signatures. 
5. Resolution 946-E/21 which regulates technical aspects related to licensed certification service providers.

Types of Electronic Signatures:

The Law defines two types of electronic signatures, the "digital signature" and the "electronic signature", as follows:

(a) Digital Signature is the result of applying a mathematical code to a digital document that requires information only known by the signatory and that may be verified by third parties allowing them to identify the signatory and detect any alteration of the relevant document. Digital signatures are valid if they are certified through a digital certificate issued by an Argentine licensed certification service provider or through a foreign digital certificate, provided that such foreign digital certificate complies with the requirements set forth by the Law which, in general terms, requires compliance with minimum internationally accepted standards.

(b) Electronic Signature is the electronic data that is integrated and/or associated to other electronic data in a logical manner but that does not comply with the requirements set forth for digital signatures. Some examples of electronic signatures are the signatures inserted on an email, the "accept" button included in terms and conditions, or any other "click-through" agreements.

Digital signatures are permitted according to ANMAT. 

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

The use of ePro is permitted in Argentina and usage is expected to increase in coming years.

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

Home nursing is permitted as long as the procedures for visits and recording of data are described in SOPs.

7.11 Considerations/Requirements for HHC - Home Lab Collection

Home lab collection is permitted as long as the procedures for visits and recording of data are described in SOPs.

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

The supply of products to the patient must meet Good Distribution Practices. Therefore, DTP delivery is unlikely to be acceptable unless additional measures are put in place. 

7.13 Considerations/Requirements for the Use of Telemedicine

In 2019, the Argentine Ministry of Health published a guide of recommendations for the supply of ‘telehealth’ (Disposition No. 21/2019). The "Recommendations for the use of telehealth: a meeting between the health professional and the patient using real-time ICT" were prepared by a group of healthcare providers, coordinated by the Ministry of Health, with the objective of creating a guideline for the provision of telehealth in a safe, efficient, and ethical way. Before the COVID-19 pandemic, this guide of recommendations was voluntarily applied by private health insurers that offered this type of healthcare, but compliance with it was not mandatory. However, this has changed since the COVID-19 pandemic and the lockdown measures adopted by the Argentine Government.

Currently, the Government has ratified the application of these recommendations for diagnosing and treating COVID-19 and other general diseases. Pursuant to General Resolution No. 282/2020 of the Superintendency of Health Services ("Superintendencia de Servicios de Salud"), all private health insurers must employ and promote the use of teleconsultation platforms in order to provide healthcare treatments. In all cases, they must guarantee that the data and information collected from the patient through the use of teleconsultation platforms would be protected in the terms of Law No. 25,326 of Personal Data Protection. Moreover, telehealth platforms must, in all cases, be subject to a subsequent audit to carry out effective control by the Superintendency of Health Services.

The use of telemedicine in a clinical trial is acceptable as long as SOPs are in place to outline the practices to be followed for visiting schedules, data capture, etc. 

7.14 Considerations/Requirements for the Use of Wearables

The use of wearables that are legal in clinical trials is acceptable in Argentina, as long as appropriate training is provided to patients and SOPs are in place to describe the procedures for patient use and data capture. 

7.15 Considerations/Requirements for Remote Monitoring

Remote monitoring is acceptable according to the ANMAT position paper. 

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

In Argentina, digital health is becoming more popular as a means of improving access to the healthcare services that are provided. The government is promoting the adoption of digital health technologies such as telehealth, electronic health records, and mobile health. Some private healthcare providers and insurance firms are engaging in this technology as well.

The Ministry of Health released the National Digital Health Strategy 2018-2024 as a state policy document to set conceptual principles for the design and development of interconnected health information systems. The MoH also created and deployed a National Telehealth Platform to perform eReferrals and eConsultations countrywide. It enabled every physician to engage with other health care providers (specialists) in a protected manner utilizing a personal computer or a mobile device, even if they do not have an EHR in place.