Use of the DIA TMF Reference Model by CROs

Here’s a quick plug for a great article about the use of the DIA TMF Reference Model by CROs. The Reference Model is a standardized model for the structure and content of the essential documents that comprise the trial master file for all clinical trials that was developed by a working group within the Drug Information Association (DIA). Take-up by the industry has been very rapid but especially so by contract research organizations (CROs) who see the model as a means of reducing differences – and therefore cost – between the filing practices employed for their clients’ documentation.

Click HERE to access the article.

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

Beware sending spam emails!

The UK Information Commissioner’s Office (ICO) will shortly get increased powers to levy fines against companies that breach the rules regarding sending of unwanted emails (spam). The increased financial penalties – up to £500,000 – come into force as part of the Privacy and Electronic Communications Regulations (PECR). The ICO will also be given greater investigative and auditing powers. The powers extend to unwanted marketing emails and texts as well as marketing telephone calls. The new rules also cover use of cookies and related technologies for tracking online user activity.

Posted in Regulations | Leave a comment

eTMF Workshop, London – Thursday 15th September 2011

Due to demand, Phlexglobal and Rammell Consulting are repeating their highly successful one-day workshop entitled “Migrating from Paper Trial Master Files to Electronic”. The next workshop will be held at the Heathrow Touchbase Conference Centre located just outside Heathrow Airport on Thursday 15th September, starting at 09:00am and finsihing at 05:00pm.

A delegate at the last workshop left the following feedback: “I definately gained benefit from the workshop – I think this was one of the best training courses I have ever attended.” Make sure you don’t miss out this time by booking early; an early-booking discount is available until 2nd July.

For more details., including online booking, please go to

Posted in Technology, TMF, Training | Leave a comment

Rammell Consulting Enters the World of Blogging

For several years, Rammell Consulting offered interested records management professionals a regular email newsletter containing items of news that I thought would be of interest. I stopped the service a while back due to issues with our email marketing provider but I didn’t provide a replacement service. Having reviewed the available technologies, I have decided to use this blogging service to bring news to our customers and contacts.

The blog will provide an opportunity for those who do not wish to subscribe to a service to browse these pages as and when they feel like it, rather than feeling obliged to register their details. On the other hand, if you wish to see what we publish regularly, you can subscribe to this blog via RSS feed by clicking on the RSS link in the sidebar.

A blog also provides a two-way communication tool. So if you have any comments or other feedback, please feel free to post a comment. Seen a website or news item of interest? Let me know about it and I’ll post it on our blog pages. I’m hoping to post news about once each week but perhaps more frequently if there is some “hot news” to bring to you all. Happy reading!!

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