eTMFs from your Contract Research Organization (CRO)

I was recently asked what happens at the end of a clinical project when the CRO managing the study wants to hand over an electronic trial master file (eTMF). The sponsor may not have an existing eTMF to take the records and sometimes the CRO offers remote access to the eTMF via a web link.

Actually, the situation is very similar to the use of an electronic data capture (EDC) system…. the same sort of questions should be asked and the same principles apply. Firstly, it is critical that pertinent questions are asked during pre-study discussions with the CRO and well before the study actually starts. The CRO and sponsor need to agree (a) in what format the documentation will be returned, (b) what medium will be used and (c) the timing of the transfer. The answers to those questions have many dependencies but one of the most important is whether or not the sponsor has a system that the eTMF data can be imported into. With the advent of the DIA TMF Reference Model, the possibility of electronic document interchange between systems is becoming a real possibility. However, for most sponsors and CROs, this is not usually possible.

Although CD-ROM or DVD are acceptable transfer media, I would not recommend them as archival storage media as their longevity is very questionable. If CD-ROM/DVD is used to transfer the eTMF between CRO and sponsor, the content should be integrated into the standard IT infrastructure of the sponsor once in-house i.e. transferred to an electronic archive store or to a secure network storage location where it will be regularly backed up.

I would not necessarily advocate relying on a web link provided by the CRO unless (a) the CRO could be relied upon to maintain the hardware/software in order to access the data across its lifetime and (b) there was a reliable internet connection. If these two requirements were satisfied, this could be an acceptable approach so long as the necessary service level agreements were in place and there was documented due diligence regarding the CRO and its systems. This really is just a form of Cloud storage.

The format of the eTMF is another important issue. If the data is not being integrated into an existing sponsor eTMF and the CRO are not providing and maintaining web access, then the eTMF needs to be transferred in a format which facilitates easy accee to the content over a long period of time. The data therefore needs to be system independent i.e. NOT saved as a docbase or database that is reliant on proprietary document management software for access but rather as a file structure of individual electronic documents, preferably saved in PDF/A format. Search portals can easily be built using products such as Microsoft’s SharePoint to access such data stores. As a last resort, the CRO could print down the content but this should really be avoided if at all possible!

Lastly the issue of timing. This is often overlooked during initial discussions between sponsor and CRO but there needs to be an agreement on when the transfer of the eTMF will take place. Also agreement on what content the CRO will remove and retain i.e. any CRO-specific content.

Make sure you have answers to these questions BEFORE your clinical trial starts…. not when you receive a CD-ROM in the mail from your CRO!!

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Posted in e-records, Technology, TMF | 2 Comments

PDF/A Standard Now Uses PDF v1.7

The International Organisation for Standardisation has just released the second part of its standard for long-term digital preservation of documents, ISO 19005-2:2011. The first part of the standard (ISO 19005-1) was issued in 2005 and describes the file format PDF/A which is based upon v1.4 of the portable document format (PDF).

ISO 19005-2:2011 specifies the use of PDF 1.7, as formalised in ISO 32000-1, for preserving the static visual representation of page-based electronic documents over time. The additional features of this format include improved support for new document technologies such as JPEG2000 compression and transparency/layer effects. Importantly, it also has provision for embedding digital signatures in archived documents in accordance with the PDF Advanced Electronic Signatures standard. This will be of particular interest to organisations that need to preserve – and demonstrate – the integrity and authenticity of digitally signed documents over a long period of time for compliance or litigation purposes.

The standard is available for purchase from ISO for CHF 136.

Posted in Document Storage, e-records, Technology | 1 Comment

Are You Drowning in Email?

Whenever I chat with business colleagues, one of the most common issues that gets raised is that of email management: we’re receiving too much and spend too much time responding. Well, I just came across an “Email Charter” and thought it worth sharing with you all. It really is just common sense but as the authors point out, it needs the whole community to get behind the charter and start following the principles. I’ve listed below the 10 points of the charter but I’d encourage you to take a look for yourself at the whole content… it only takes a few minutes to read the whole charter.

  • Respect Recipient’s Time
  • Short or Slow is Not Rude
  • Celbrate Clarity
  • Quash Open-ended Questions
  • Slash Surplus cc’s
  • Tighten the Thread
  • Attack Attachments
  • Give These Gifts: EOM & NNTR
  • Cut Contentless Responses
  • Disconnect!

Must remember to start implementing! You can find the Email Charter here.

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

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.

Posted in Compliance | Leave a comment

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.

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

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