Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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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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

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TMF Reference Model Gains Momentum

The Trial Master File Reference Model (TMF RM), a supported initiative through the Document and Records Management SIAC of the Drug Information Association (DIA) is a standard reference for the contents of a Trial Master File. First published in 2010, … Continue reading

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Will ePub or HTML5 Be The New Standard for Electronic Records?

As an industry, I think records managers and archivists have generally welcomed the emergence of PDF and PDF/A as a standard for the creation and preservation of documents. At last we have a format that enables us to view documents … Continue reading

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DIA EDM Corner Has Moved

This is just a quick notification that as a result of restructuring of the DIA (Drug Information Association) website, the link to the EDM Corner has now changed. The EDM Corner contains links to Trial Master File Reference Model and … Continue reading

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GCP Records Management – How Are We Doing in Canada?

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

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