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9th Dec 2021, 04:53 PM
#1
Clinical trials Regulation EU No 536/2014 - record retention responsibilities of CROs
Regarding this directive - as a CRO - what would be the responsibility for retention of trial data and supporting information beyond study lock?
What data to retain?
How long for?
What format must the data be in? (bearing in mind technology-ageing issues of EDC systems that may be decommissioned within the retention period)
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