Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

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Could Investigator Databank Provide a Central Repository for CVs?

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

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How Much Do YOU Know About eTMFs?

We have been maintaining Trial Master Files for many years with increasing levels of consistency and quality since the introduction of Good Clinical Practice guidelines in the 1990’s and more latterly, the publication of European Directives and Regulations that make … Continue reading

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MHRA Guidance on Good Clinical Practice

On 24th September 2012 the Medicines and Healthcare products Regulatory Agency (MHRA) published a Good Clinical Practice Guide. Containing 542 pages, this is an essential reference book for anyone involved in some way with the conduct of clinical trials of … Continue reading

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Are You Struggling with Electronic Records?

In many ways, the management of electronic records is no different from the management of paper records. But – and it is a big ‘but’ – there are a few significant differences and one of these is the approach that … Continue reading

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The eTMF Solutions Basket Gets Bigger

Just a quick note to mention that a few more vendors providing solutions for electronic trial master files (eTMFs) have been added to our growing list. In addition to this list of packages solutions, there is also a large selection … Continue reading

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Digital Preservation – An Industry Initiative to Develop Standards

The challenge of ensuring the long-term accessibility, reliability and authenticity of archived electronic records has been with us for some time, particularly in an industry where retention times can be in excess of 15 years…. sometimes for the marketed life … Continue reading

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