Financial Disclosure to FDA – New Draft Guidance Available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 guidance provides additional clarification on the rules for financial disclosure; no changes to the rules themselves are being introduced by the guidance document. The guidance confirms that financial disclosure forms are not submitted as part of an IND/IDE but as part of a marketing application. Sponsors should therefore have systems in place to adequately manage these records until they are needed for submission. The guidance also clarifies the expected level of due diligence in the event that the sponsor has difficulties obtaining information directly from clinical investigators. Sponsors may be asked to demonstrate that due diligence has been followed, so keep appropriate records of this. However, the FDA do note that they “do not require sponsors to establish elaborate tracking systems to collect financial information”. So the message is: keep it simple, keep it accurate, keep it until needed.

With respect to record keeping systems however, it should be noted that financial interest information should be retained for 2 years following the date of approval of a marketing application. Systems should therefore be in place to facilitate the removal and destruction of financial interest information once this time period has expired, remembering that information on file may also relate to other marketing applications.

One area that does not appear to be covered in the guidance is that of data protection / data privacy. With the increasing use of electronic document management systems (eTMFs) amongst sponsor companies, there is some concern that access to financial information may become available to a wider audience than was previously available when filing systems were in hard-copy. Remember that financial disclosure obligations also include the clinical investigator’s spouse and dependent children. Have they given consent to their personal data being disclosed to everyone in the sponsor’s company?

Comments to the FDA are due by 25 July 2011.

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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 is extremely comprehensive and should give anyone a thorough understanding of the issues involved if they are contemplating a move into this area.

The document is currently in draft form. If you wish to make a comment to NIST, you may do so up to 13th June 2011 with an email to

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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 an important role in balancing the legal and regulatory requirements for the retention/destruction of records with the varying needs of the business, identifying a solution that is based upon a solid risk management strategy.

This week, I am co-presenting a workshop on the topic of retention scheduling with my colleague Russell Joyce (Heath Barrowcliff Consulting) at the Spring Conference of the Scientific Archivists Group. If you are quick, you might just be able to book yourself a place on what promises to be another interesting conference.

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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 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.

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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.

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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 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

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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 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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