Tag Archives: MR-001

After the MR-001, the MR-002…

After the MR-001, the MR-002…

In a previous blog post that you can find here, we told you about the RM-001, procedure simplifying the data processing statement during biomedical research at the CNIL-France (National Commission for Data Protection and Liberties). Do you know that this summer, a new methodology of reference, the MR-002, was created? It was published in the Official Journal on August 22nd. In this article we will explain what it is.

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Recherches utilisés pour trouver cet article :durée conservation données MR001,mr 001,mr002,CLAUSE MR002

Vanessa Montanari

Je suis Vanessa Montanari, attachée de recherche clinique, chef de projet et dirigeante, depuis 6 ans, de Pharmaspecific, ma propre société de prestation de services, en recherche clinique. www.pharmaspecific.fr

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Invalidation of Safe Harbor, what to do?

Invalidation of Safe Harbor, what to do?

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.

Personal datas transfer to USA now illegal.

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Recherches utilisés pour trouver cet article :invalidation of Safe Harbor

Vanessa Montanari

Je suis Vanessa Montanari, attachée de recherche clinique, chef de projet et dirigeante, depuis 6 ans, de Pharmaspecific, ma propre société de prestation de services, en recherche clinique. www.pharmaspecific.fr

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The MR-001, what is it and how to respect it?

The MR-001, what is it and how to respect it?

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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Recherches utilisés pour trouver cet article :MR001,mr-001,ethnie essai clinique france,hia st anne et mr003 cnil,mr 001 traitement des données hors france,MR clinique,MR-001 CNIL,MR001 ou MR004

Vanessa Montanari

Je suis Vanessa Montanari, attachée de recherche clinique, chef de projet et dirigeante, depuis 6 ans, de Pharmaspecific, ma propre société de prestation de services, en recherche clinique. www.pharmaspecific.fr

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