Category Archives: Regulations

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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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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Is Facebook a Validated System?

Well, of course the answer to the question posed in the title is a clear “No”…. at least as far as the pharmaceutical and biopharmaceutical industry understands and interprets validation. So why the question? My eye was drawn to an … Continue reading

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Ensure Your Informed Consent Forms Comply With New Requirements

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

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GMP Directive (2003/94/EC) to cover active substances?

The European Commission are proposing to extend the scope of Directive 2003/94/EC to cover active substances, including the manufacture of active substances. The intent is to bring cohesion of requirements for active substances and medicinal products. However, since all of … Continue reading

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