Category Archives: TMF

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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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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Are Copies as Acceptable as Original Documents?

This is a question that I seem to be hearing with increasing frequency! I think the reason for this is that an increasing number of companies and organizations are introducing electronic document management systems (EDMS). Where there are hard-copy records … Continue reading

Posted in Compliance, e-records, Litigation, Records management practice, TMF | 2 Comments

MHRA Opens Public Consultation on Review of UK Medicines Legislation

On 25th October, the MHRA opened a consultation period of 12 weeks for their review and consolidation of UK legislation pertinent to manufacture and use of medicines. Many requirements relating to the creation, management and retention of medical records are … Continue reading

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eTMF Vendors – Who Has the Largest Market Share?

This is a question just sent through to us….. which vendor has the largest market share of the eTMF solution vendors? I guess the answer will depend on whether we’re talking about most client licenses/seats or highest volume of sales and whether … Continue reading

Posted in e-records, TMF | 2 Comments