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The recent news O2/IBM has misplaced a data tape containing unencrypted personal data just emphasises to me the need to have a secure chain of custody for our data and records. This means ensuring that when records are passed from … Continue reading
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
Applied Clinical Trials reported this week news that Janssen Research & Development are establishing a global, cross-pharmaceutical Investigator Databank to improve the efficiency of industry-sponsored clinical trials. The Investigator Databank, to be hosted by DrugDev.org, will hold key information about … Continue reading
It seems that most of our electronic communications automatically generate a record that we are able to capture – if we so choose – and manage in a records management system. It is now possible to implement procedures that capture … Continue reading
This question has been discussed heavily since the issue of the EU Data Protection Directive 95/46/EC back in October 1995. Over the years, there has been a concensus of opinion that patient records should be regarded as coming within the … Continue reading
Health Canada has recently released a publication summarising the results of GCP inspections carried out between April 2004 and March 2011. It makes for interesting reading compared to a similar document released by the MHRA three years ago. At 24.5% … Continue reading
For those sponsors conducting clinical trials that need to comply with FDA regulations, remember that from 7th March 2012 your informed consent documentation must comply with the new 21 CFR § 50.25(c) requirement. This requires the informed consent form to … Continue reading