5. Investigator and Investigational Product

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?

No. However, as per the National Administration of Drugs, Foods and Medical Devices Regulation 6677/10, “the investigator shall be suitably trained and experienced to conduct a clinical pharmacology study, as detailed in his or her curriculum Vitae and proofs attached thereto”.

5.2 Does local regulation require any specific documents if PI/CI is based outside the country?

Not applicable.

5.3 Does local authority allow electronic ICF administration, including electronic signatures?

Yes, the email format is accepted. The requirements for eConsent are outlined in Section 7.7 of this guidebook.

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

No.

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

As per the Ministry of Health’s Resolution 1480/2011:

Recording of clinical data

The protocol should describe the procedures designed for obtaining and recording participants' clinical data, as well as the method of encoding the data to preserve their confidentiality.

The investigator must respect the truthfulness, readability, consistency, and timeliness of the clinical data records of the study both in the medical records and in clinical data registration forms or spreadsheets that are used, as well as the confidentiality of participant information.

If automated devices are used to perform study measurements, such as electrocardiograms and spirometries, an identifiable printed source document of the procedure performed must be obtained and filed in the clinical record.

5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

Products must be supplied by the sponsor to the patient and cannot be purchased OTC.

5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)?

All products for clinical trials are to be provided at no cost to the participant and paid for upfront by the sponsor or CRO.

5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range?

There is no regulation against the payment of stipends. However, the sponsor is responsible for affording all the research costs, including study treatments and procedures. In clinical studies with a therapeutic benefit, the sponsor may make payments to the participants for any inconveniences and their time. However, such payments may not become an undue influence by being disproportionate in such a way that the patient is persuaded to run unnecessary risks. Payments shall be apportioned according to the study characteristics.

5.9 Specific labeling requirements for clinical study product

All medical device labels must contain the product description, information on how the product should be stored, product expiration date (if applicable), and information about the importer, including the address of the importing company.

Section 3 of Executive Decree No. 150/1992 (as amended and complemented), provides that labels must state the laboratory’s name, the laboratory’s domicile, the name of the Technical Director, the name of the product, and the generic name of the drug in the same size and lettering style, the pharmaceutical form, the expiration date, how the drug should be stored and the conditions for sale, the sequence of manufacturing and the wording “drug approved by ANMAT, certificate number XXX”.

5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics?

Details are provided on the ANMAT website: https://www.argentina.gob.ar/anmat.

5.11 What is the turn-around time to get an import permit?

It generally takes around 30 days to receive an import permit.

5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

No specific guidance was available on this matter.