Category Archives: e-records

The Multimedia TMF Becomes a Reality

The clinical records management community is currently enjoying an interesting debate regarding the need for interoperability standards for electronic trial master file (eTMF) content. The need for organizations to efficiently exchange documents and metadata between systems is becoming increasingly critical, … Continue reading

Posted in Document Storage, e-records, Regulations, TMF | Leave a comment

Are You Thinking Big Enough?

I’ve just been reading an interesting article by Bob Kocher, a partner at healthcare investment company Venrock. He was talking about investment in digital healthcare technologies and much of what he had to say rang so true to me about … Continue reading

Posted in e-records, Records management practice, Technology, TMF | Leave a comment

Is an eTMF Standard Needed?

This is a question that many of us in the clinical document management space are currently asking ourselves following the announcement by CareLex of their intention to develop and launch an industry eTMF standard under the auspices of OASIS. There already … Continue reading

Posted in e-records, Records management practice, Standards, Technology, TMF | 1 Comment

When Is a Photocopy Not a Photocopy?

It appears that the answer may be when you use a Xerox scanner to produce the copy! According to a story reported today, the “normal” scan settings on at least two models of Xerox scanner actually change the characters that … Continue reading

Posted in e-records, Technology | Leave a comment

Where Are We With ‘Digital By Default’?

The UK eGovernment Interoperability Framework (eGIF) was established over 10 years ago to include a range of different initiatives to make Government more efficient by introducing standardisation. Part of this strategy included the goal of moving towards the digitisation of … Continue reading

Posted in e-records, Records management practice, Technology | Leave a comment

Where Next for the Digital Age?

I found the BBC News story today regarding digitisation of the UK Courts system very interesting. The Government has plans to make courtrooms in England and Wales “fully digital” by the year 2016, ending what it described as “an outdated … Continue reading

Posted in e-records, Litigation, Records management practice, Technology | 2 Comments

Clinical Trials EU Regulation – Even More Bizarre

Following the recent vote of the ENVI Committee on the several hundred amendments put forward to the proposed EU Clinical Trial Regulation, the consolidated report containing all carried amendments has now been published. Report A7-0208/2013 entitled “Report on the proposal for a … Continue reading

Posted in e-records, Regulations, TMF | Leave a comment