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Our processes for data management include a step to ensure that data is saved in a read only format and saved separately from the data itself which the Trial Statistician works on. This Read Only file allows one to always go back and look at what dataset was used for that particular analysis and our SOPs state that this record is not to be deleted..
Sometimes these datasets will contain data such as DOB, and our PIL states that at the end of the trial and before archiving personal identifiers such as DOB will be redacted or even deleted. This now conflicts with the rule that each data set must be saved and never deleted!
has anyone come across this issue? if so how are you managing to sort this please?
How many of you state that you will redact personal identifiers at the end?
any help would be much appreciated.
many thanks, Joanna
Joanna Black
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