OR WAIT null SECS
Electronic Trial Master Files (eTMFs) are growing in popularity. A recent industry coalition survey summarized by eClinica reported that in 2012, 32% of survey respondents maintain inspectable TMF’s in paper only, 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.
As with most innovations, the benefits gained with eTMF also require new ways of working. One of the most important considerations for companies maintaining eTMFs or hybrid paper/eTMFs is how to handle agency audits. When paper TMFs are audited, the sponsor, CRO or investigator must ensure that all of the paper records are available, and assist the auditor in accessing them and locating information. Usually, all of the parties involved have many years’ experience in assessing the quality and completeness of the paper TMF.
With an eTMF, an inspector has new concerns: