You have studies underway and you transfer some information in the US, either the promoter or subcontractors (eCRF, CRO, patient reimbursement, or other)? Did you know that the trade agreement between the European Economic Area and the United States had been invalidated and that personal data transfers made under the Safe Harbor framework were not allowed? Here concretely what this means for your tests.
Personal datas transfer to USA now illegal.
As CRA, we are concerned with the application of the MR-001 or Reference Methodology. The MR-001 is a procedure used to simplify the reporting of data processing, in clinical trials, to the National Commission for Data Protection and Liberties (CNIL). Here we will explain what studies are involved and how to respect the MR001? Here are some answers.
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