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Clinical research
Regulation 1480/2011: A guideline for research on human subjects
Circular 3/2011: Sponsors of clinical pharmacology studies are required to e-mail the digital version of the informed consent document submitted upon application for approval of a clinical pharmacology study
Codes and forms for procedures related to clinical pharmacology studies
Regulations concerning the conduct of procedures relating to clinical pharmacology studies
Questions and answers about the Guideline of Good Clinical Practice in clinical pharmacology studies (Regulation 6677/10)
Circular 1/2011: A framework for the presentation of clinical research projects is established
Pharmaceutical companies, CROs and other sponsors of clinical pharmacology studies are hereby informed that they are required to submit to A.N.M.A.T. a one-time report on the recruitment of the first patient and/or healthy volunteer for each approved protocol.
The information required must be e-mailed to
centrosyenmiendas@anmat.gov.ar
.
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Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800