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:
- Example 2 confirms the inclusion in the TMF Reference Model of IVRS validation artifacts; the trial master file is more than just the minimum list of documents identified in ICH GCP Chapter 8
- Health Canada accept archiving of electronic records but Example 3 highlights the need for an archive strategy that ensures accessibility and readability of those records for a minimum of 25 years
- In regards to electronic records again, Example 6 highlights the need for audit trails to demonstrate that data has not been changed.
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:
- “No CVs were available for three sub-investigators”
- “No documented evidence that the personnel were trained…”
- “No explicit documentation to indicate that all […] had been informed…”
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.