Hi Carol
We do loads of CTA for US clients in Italy - and this is a very common question.
Why - the reason is that you will database data about Italian citizens - but it is not about the eCRF data, as this is typically anonymised. You will be databasing the names and addresses (professional address, and often private email addresses) of the PI and the sub-Investigators.
You need to register with the DP agency once, and you need to do this within the first 6 months of the first trial which you do in Italy.
So - if you have ever sponsored a study in Italy before, it should already have been done. If this is your first time, it is a fairly simple process.
Feel free to contact me directly, if you need any more assistance in Italy.
It is a great country for oncology, but there are certainly some "hints" to getting Italy to work for you.
Regards
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Kathryn Hutchinson
Director of Regulatory Affairs
AMS Advanced Medical Services Ltd
London
United Kingdom
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Original Message:
Sent: 03-20-2012 11:54
From: Carol Bailey
Subject: Italian Data Protection Agency
Hello All
Is there someone that has experience submitting a CTA in Italy that could provide some insight on the Data Protection Agency? I would really appreciate your input.
First of all we want to understand why is the DPA form 'needed'?
1. It has been suggested that we submit only "Table 1 - Processing of Genetic Data". We are wondering in your experience if the DPA form is submitted only when genetic data are collected?
2. Our reading of the regulation seems to say that purpose of the DPA form is to protect privacy of Italians. So 'electronic data transfer' is why we think it is needed to do this at all. If that is the case then it is needed anytime there are eCRFs whether or not they collect genetic data.
Understand exactly why and when the DPA form is required would be extremely helpful. Is it just when genetic data is captured or do all studies submit it? And which tables have you submitted?
I would appreciate hearing your experiences and what you have submitted
Thank you for your time
-carol
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Carol Bailey RAC
Director, Regulatory Affairs
OncoGenex
Bothell WA
United States
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