Challenge #24 : Can I retrieve ethnic data from the CRF in France?
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Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to talk about a new topic. Are we allowed to retrieve the ethnic data from the CRF ?
Then the answer to that question is yes. But it all depends on whether it’s scientifically justified at the level of the research protocol, at the level of the study protocol. I insist on this point because it is something that is noted in the MR001 – so our text in France, which deals with data, which talks about personal data in France in the context of clinical studies. But I am also talking about this because it has often happened in the past that there have been sponsors, particularly American sponsors, for whom the recovery of ethnic origins is something that is in fact commonplace. Often they put in their CRF, Caucasian, Latin American African-Americans and voila, Asians, and you have to tick off the ethnic origin of the person in fact. You have to know that in France, you can’t get the ethnic origins of people without that being justified in the protocol. So it’s something that you, as CRA, have to check from the beginning. That is to say that if you are an CRA who deals with the submission of the protocol, you have to look at the content of the CRF, see if there are any questions, these questions have been asked. That is to say, ethnicity is asked of the sponsors, take the opportunity immediately to ask the sponsor to explain in the protocol why they are asking for this type of data, what is the real impact of this data in the study and is it going to have an impact for the treatment of the patient. If the study has already started and the people who were in charge of submitting the submission did not think about this point, you can tell your sponsor that you cannot retrieve this data unless you actually amend the protocol and at that time, so the sponsor will have to make an amendment. If in fact they were to retrieve that data. If not, you have to check that it’s not allowed by law, and you’re not allowed to retrieve that data as part of the study. So it’s your role as CRA to make sure that point, and you can’t allow data to come out of Europe, data that’s not authorized, that there’s no justification within the study protocol. That’s the point.
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