Rammell Consulting Limited

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% of findings, records management issues account for a much higher percentage of inspection findings than for the earlier MHRA report. Many of the findings were due to documentation simply not being present in the file but the examples quoted in the report reveal some interesting points:

As in the MHRA report however, the categorisation of findings actually disguises the true extent of records-related problems. For example, findings categorised as “Qualifications, Education and Training of Personnel” were:

In my mind, these are actually records management issues i.e. failure to generate required documentation for the Trial Master File. Similar examples can be seen against the other inspection finding categories.

So what does this tell us? That we are still struggling to manage the vast quantities of records that our regulations require us to generate and retain. Initiatives such as the emergence of an industry TMF Reference Model will help to ensure consistent and comprehensive content but we also need tools to ensure that content is properly managed.