I have a few questions on this topic. The first being, are we any further forward in the access to the systems to review Clinical Trial data from source records? I completely agree and empathise with the restrictions that are needed to preserve non trial patient confidentiality but surely someone could have thought to design a system which would allow access to a discrete set of records electronically, either by a reporting function or otherwise? I know for a fact that many staff enter these clinical systems and are not sure of all the nooks and cranny's within the system so printing out does not always give all information and can sometimes be very selective.

The second point is - these printouts - where are they being stored at the end of the study? I was recently told (not UK) that the printouts used by the monitor for SDV could not be kept at the end of the study. I accepted this because of the fact that the system in use was fully validated and informatoin entered could not be modified or changed without the audit trail function. It was also possible to see who had entered the data and when plus who had printed the data and when. So are these printouts always being kept and in the event of an audit or inspection what checks are being done to ensure that the data has not been modified or is identical to the printouts? I note the point about chronological notes and retaining of previous printouts but how many trusts or GPs or the like have a proper SOP or equivalent in place to do this at their site?

The third point is those sites which will not print and sign and date in a timely manner or will only do it once, or will not go back and confirm that nothing has been changed. How are these being dealt with?

My last point is that I believe that CRAs/Monitors are not being trained sufficiently in how to assess e systems at site and due to their lack of knowledge they are unable to extrapolate what they see and find back to the regulations and also, when faced with issues at site they are either oblivious to them or just do not know how to handle the issue. By the time it is escalated it is too late and an "elastoplast" approach has to be made. Going back to point 2, if it was a requirement to have a process within a GP or hospital etc for the use of EMR in clinical trials (i.e. their SOP for their site) then monitors/sponsor staff could ask for this at Pre study visits and then use this as the basis for confirming if it was possible or practical to use the site.

So, over a year on from the original poster's question - is there anything to add or are clinical trials and technoliogy still at odds?