Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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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British Standard BS 5454:2000 Withdrawn

The British Standard BS 5454 Recommendations for the Storage and Exhibition of Archival Documents has been in existence in one form or other since the late 1970’s. Throughout this period, it has been a fairly succint document (last revision contained … Continue reading

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What is your Policy for Making a Record of Telephone Conversations?

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

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Should Clinical Trial Data be Regarded as Personal Data?

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

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