Daily Archives: November 26, 2012

Should Clinical Trial Data be Excluded from Data Protection Act Requirements?

Let’s start off the week with a controversional question! A Code of Practice released by the UK Information Commissions Office on 20 November adds an interesting slant to the question. The Code of Practice (Anonymisation: Managing Data Protection Risk) reconfirms that … Continue reading

Posted in Compliance, Data protection, Records management practice | Leave a comment

TMF Reference Model Revised

The Trial Master File (TMF) Reference Model consists of standardized taxonomy that outlines the clear definition and organization of TMF content using standard nomenclature. This model, developed by a working group of the DIA Document Management Special Interest Area Community … Continue reading

Posted in Records management practice, Regulations, TMF | Leave a comment