Highlights of the 2012 Metrics Survey

An overview of the 2012 metrics survey has recently been made available.

The data indicates a significant growth in the number of organizations transitioning to eTMF.  32% of survey respondents maintain inspectable TMF’s in paper, down from 50% in the corresponding 2010 survey.  While there is only a modest increase in the number of respondents maintaining inspectable electronic TMFs (8%), the increase in the number of respondents maintaining a combination of paper and electronic was significant – 48% in 2012, compared to just 27% in 2010, indicating a continuing transition to eTMF in the industry.  The data on the current status of eTMFs in the industry also supports a trend to implementing eTMFs.  The 2012 survey reveals that 28% of respondents are currently using an eTMF, and 57% are in the process of planning, building or evaluating eTMF.  (In 2010, only 45% of respondents reported active building or evaluating of an eTMF.) Meanwhile, only 3% of respondents said they are not considering eTMF.

Adoption of the TMF Reference Model is also changing the landscape of trial master file management, especially for new trials just being launched.  Most respondents working with the reference model have updated their SOPs, guidance documents, and file structures to align with industry best practice.  Implementation of the TMF RM and alignment on SOPs and guidance documents may significantly ease the administrative burden in regulatory inspections, industry partnerships, collaboration between sponsors and CROs or acquisitions.

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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