What solution for my eTMF?

We often get asked what technology solutions are available for the management of electronic trial master file content. There are countless companies that provide bespoke IT development services to build your own system, often based around Sharepoint or Documentum. However, there are now an increasing number of software tools that are preconfigured for managing eTMFs.

We have therefore begun to pull together a list of these solutions to help our clients. If you know of a product, please do not hesitate to respond to us with the details and we’ll add to the list. For more information, please click here.

Posted in e-records, TMF | 1 Comment

Search FDA Warning Letters

Did you know that the FDA have recently (26th May 2011) provided an advanced search capability on their Warning Letters web pages? The advanced search page now gives you the ability to search for company name (including wildcard), date range searching for when the letter was issued, the issuing office, the subject of the letter (select from drop-down list), whether or not a response letter has been posted and whether or not a closeout letter is available.

This should improve the utility of this information resource for everyone from quality and records management professionals through to CROs, clincal investigators and manufacturers.

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Guidelines for GP Electronic Patient Records

The Department of Health have recently (21 March 2011) revised their good practice guidelines for GP electronic patient records. I’ve just been browsing through the document and whilst much of the content is not directly applicable to me, I was struck with how relevant some of the guiding principles are to (a) the development of electronic records management solutions and (b) to sound records management practice.

For example, Chapter 4 covers the topic of Records Governance and makes reference to the legal framework within which patient record systems need to operate and a numebr of applicable standards. Many of those cited have direct relevance to a wider audience. There are also some great principles laid down in Chapter 6 – High Quality Patient Records. I think we could all benefit by taking note of the content here and making sure it is embedded in systems that we work on!

Click here to download a copy of the guidelines or access it from www.dh.gov.uk.

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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.

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 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 800-146comments@nist.gov.

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 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.

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