Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

Financial Disclosure to FDA – New Draft Guidance Available

Yesterday, 24 May 2011, the Food & Drug Administration (FDA) released for public review and comment a draft revision of the guidance for financial disclosure by clinical investigators. This will replace the last guidance issued back in 2001. The revised … Continue reading

Posted in Regulations, TMF | Leave a comment

NIST Releases New Draft Cloud Computing Synopsis

The National Institute of Standards and Technology (NIST) has released a very interesting (but long!) document (click HERE to download) that explains cloud computing technology in plain terminology. At 84 pages and 1.9Mb, it is not a brief document but … Continue reading

Posted in e-records, Technology | Leave a comment

Retention schedules – Finding your way through the maze

The development and use of records retention schedules is fundamental to good records management practice. However, it is a topic that is often misunderstood and one that frequently poses a challenge to records managers and archivists. The records manager has … Continue reading

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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 … Continue reading

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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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