Category Archives: e-records

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

Clinical Trials EU Regulation – An Update

You will remember that I wrote a few weeks ago about the proposed Clinical Trial Regulation which will replace EU Directive 2001/20/EC. Specifically, myself and many of my industry records management colleagues were extremely concerned about Amendment 60 which was … Continue reading

Posted in e-records, Regulations, TMF | 1 Comment

An eTMF is For Life, Not Just For Christmas! Achieving Archive Compliance

This is the title of the next webinar that we are involved with. This topical webinar will be structured as follows: Karen Redding of Phlexglobal will present the current eTMF industry status and how eArchiving is not being addressed;     Eldin … Continue reading

Posted in e-records, Technology, TMF, Training

Why are Signatures Missing from the Average Office Computer Desktop?

Have you ever thought about the decision-making process for the purchase of office desktop software? I’ve never been involved in this activity so it is something I admit to knowing almost nothing about! However, there is one aspect that has … Continue reading

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

Migration Options for SharePoint 2013: Consider Your Options Carefully

This is the title of a blog posted recently on the AIIM website and I’d encourage you to take a look. The reason that I’m highlighting this link is because it is just so relevant given the presentation that I … Continue reading

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

TMF, eTMF, eTMF System…. What is the Difference?

One of the questions that I get asked repeatedly is what exactly is the trial master file (TMF). I represented this graphically a number of years ago, as follows: For quite a while, industry thought that the TMF was just … Continue reading

Posted in e-records, TMF | Leave a comment

Do You Have a Secure Chain of Custody?

The recent news O2/IBM has misplaced a data tape containing unencrypted personal data just emphasises to me the need to have a secure chain of custody for our data and records. This means ensuring that when records are passed from … Continue reading

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