Should Clinical Trial Data be Excluded from Data Protection Act Requirements?

Let’s start off the week with a controversional question! A Code of Practice released by the UK Information Commissions Office on 20 November adds an interesting slant to the question. The Code of Practice (Anonymisation: Managing Data Protection Risk) reconfirms that the Data Protection Directive – dating back to 1995 – says that the principles of data protection do not apply to data rendered anonymous.

The Good Clinical Practice (GCP) community have typically interpreted clinical trial patient data as not falling within this definition because, although the data is anonymised, there still exists a code list held by the clinical trial investigator which links the patient number with the actual patient identity (the subject identification code list). However, the new Code of Practice clarifies the point that the Data Protection Act does not require anonymisation to be completely risk free or to be 100%. The data protection authority in Hamburg have gone further to state that ‘rendering anonymous’ is defined as “the alteration of personal data so that information concerning personal or material circumstances cannot be attributed to an identified or identifiable natural person or that such attribution would require a disproportionate amount of time, expense and effort‘. It is therefore acknowledged that the absolute impossibility for re-identification in practice cannot always be achieved.

Industry has usually maintained that because there exists a theoretical possibility that somebody may use the subject ID list to link the anonymised data with the original patient records, then the data is to be considered as personal data within the definition of the Data Protection Directive. However, the Code of Practice gives an example where an anonymisation code is actually held by the same organisation who holds the private data and this is to be considered sufficiently anonymised so long as there are security systems in place (policies and procedures) to prevent a link being made. In the GCP scenario, the anonymised data and the code list are held by separate entities (sponsor and investigator) under strict GCP principles and contractual obligations to keep the code secure. The case is therefore stronger!

In fact, to avoid any further ambiguity, the Code of Practice actually uses clinical trial data as one of its case studies in Annex 2. It concludes that the risk of discosure of the key code is sufficiently low to consider the data held by the trial sponsor to be completely anonmysied and therefore not within the restrictions of the Data Protection Directive and Data Protection Act.

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Could Investigator Databank Provide a Central Repository for CVs?

Applied Clinical Trials reported this week news that Janssen Research & Development are establishing a global, cross-pharmaceutical Investigator Databank to improve the efficiency of industry-sponsored clinical trials. The Investigator Databank, to be hosted by, will hold key information about clinical investigator sites including their infrastructure and “good clinical practice (GCP) training records”.

As these types of initiatives are developed and become more commonplace, it remains to be seen whether the expectation of regulatory inspectors will be that the industry sponsors maintains a copy of training records and CVs for trial staff, or whether it would be acceptable to cite the Investigator Databank as the official repository for such information. The latter would certainly remove one of the administrative burdens of managing trials, namely ensuring that an up-to-date CV is on file for key trial site personnel. It would of course be necessary to have certain guarantees that the records held at were kept up-to-date and retained for the required period of time.

As collaborative efforts across industry increase, I’m sure we’ll see more of these issues arising. The challenge will be whether or not regulatory authorities and industry can accommodate a paradigm shift in terms of record maintenance and ownership.

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How Much Do YOU Know About eTMFs?

We have been maintaining Trial Master Files for many years with increasing levels of consistency and quality since the introduction of Good Clinical Practice guidelines in the 1990’s and more latterly, the publication of European Directives and Regulations that make compliance a legal obligation. However, a quick review of published agency inspection findings shows that industry and clinical sites are still making many mistakes when it comes to document management. So do we really understand what the regulatory requirements and, importantly, how to comply with them in an efficient and cost effective way? Add to this the advent of technological solutions that now make it possible to manage our TMF content electronically, and we have a whole realm of other challenges to face.

For example, do you understand:

  • what type of file structure the regulatory agencies may expect to find when they inspect your trial master file?
  • what the indexing requirements are for the trial master file?
  • what records related to third parties you are expected to maintain when you outsource trial activities?
  • how you file emails, email conversation threads and email attachments?
  • where you file documents such as the DSUR which may appear in several places (Ethics, Regulatory, Safety)?
  • what the validation expectations are for an electronic trial master file (eTMF)?
  • whether electronic signatures are permitted and if so, how they should be implemented?
  • whether it is allowed to destroy paper original documents after they have been scanned into an eTMF?
  • how you can provide the site with an electronic investigator site file (eISF) and what regulations you need to follow?

These questions – and many more – will be answered at a one-day workshop dedicated entirely to the subject of trial master files and electronic trial master files. The workshop is being run on Wednesday 28th November in Munich immediately prior to the 13th DIA Electronic Document Management Conference. Your workshop presenters are Eldin Rammell, Managing Director, Rammell Consulting Ltd and Karen Redding, Business Development Director, Phlexglobal Ltd. The workshop content has recently been re-written to include latest industry and agency experiences, more focus on electronic signatures and eTMF implementation challenges. This content-packed workshop is great value as a stand-alone training event at €550 (approx. £440) but can also be taken as an optional extra to the DIA EDM Conference. The workshop fee is fixed but if you also plan to attend the conference please note that the closing date for the conference early-bird discount is approaching fast. This workshop held in previous years has been fully booked!


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MHRA Guidance on Good Clinical Practice

On 24th September 2012 the Medicines and Healthcare products Regulatory Agency (MHRA) published a Good Clinical Practice Guide. Containing 542 pages, this is an essential reference book for anyone involved in some way with the conduct of clinical trials of medicines for human use in the UK. In addition to a chapter entitled “Key Trial Documentation” (chapter 4), it has a whole 29 pages devoted to the trial master file and archiving (chapter 10).

There are no great suprises in the guide. However, the guide states very clearly in black-and-white the MHRA viewpoint on many of the issues that have caused controversy and discussion over the years. I have picked out just a few examples to whet your appetite:

  • The contents of the TMF should be sufficient to adequately reconstruct the trial, along with key decisions
  • The TMF will be more than just the documents identified in ICH GCP as essential documents
  • Signatures are only recommended where they add value. The guide also acknowledges that wet-ink signatures are usually just down to internal requirements; if your SOPs don’t mandate that a signature is required, it is likely that your documents don’t need to be signed!
  • Ideally, the TMF should be a stand-alone set of documents rather than distributed across different file systems or electronic systems
  • Emphasises the need for a document management plan when using a CRO
  • Describes the inspectors’ expectations for “maintaining the TMF in a timely manner”
  • Emphasises the unacceptability of an electronic Investigator Site File (eISF) to be held by the sponsor at the end of a trial which the site accesses via a portal (the ISF must be controlled by the site)
  • Describes what is meant and required by QC of scanned images
  • Describes the requirements of an electronic trial master file (eTMF)
  • Confirms that destruction of original records following scanning is not ruled out, subject to several caveats

I think this will become an indispensable guide for the clinical records manager, clinical trial administrator and others involved in clinical trial activities. At £45, it may be beyond some budgets so I’d recommend getting a copy for your organization / company and taking a look through. Happy reading!

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Are You Struggling with Electronic Records?

In many ways, the management of electronic records is no different from the management of paper records. But – and it is a big ‘but’ – there are a few significant differences and one of these is the approach that is taken with archiving of electronic records. For sure there are parallels betweeen the paper and the electronic world. For example, we have to consider the environmental protection of archived physical records just as we have to think of the protection of electronic records. However, there are some important challenges in the e-world.

These challenges can be categorised into system – or technical – issues, process issues and records management issues. The Scientific Archivists Group has recently been getting to grips with these issues and is shortly to release a draft guideline for electronic records and electronic archiving, structured around these three key areas. What is becoming apparent is the need for organizations to develop a digital preservation strategy that addresses each of these three areas, touching on software, hardware and storage media obsolescence as well as understanding the long-term information access requirements of the organization.

To find out more about this important topic, I recommend that you attend the forthcoming Scientific Archivists Group Conference. This is being held on 11th and 12th October in Bristol, United Kingdom. The agenda includes a detailed explanation and discussion on the draft guideline contents as well as the DGGF digitization White Paper and a presentation from Christine Gray, MHRA on the UK MHRA GLP Monitoring Authority view on these issues. This is also a great conference for networking with like-minded professionals. At £337.50, the full conference fee – including 1 night accommodation, all refreshments, drinks reception and conference dinner – represents great value for money. See you there…. but register quickly as there are limited places!!

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The eTMF Solutions Basket Gets Bigger

Just a quick note to mention that a few more vendors providing solutions for electronic trial master files (eTMFs) have been added to our growing list. In addition to this list of packages solutions, there is also a large selection of technology companies and specialist consultancies who will custom build an eTMF solution for you. As this list is huge, we have not attempted to compile the list but this omission does not imply that their products are in any way inferior to the off-the-shelf solutions. It should also be noted that most of the off-the-shelf solutions will need configuration and may also need customization to meet your business needs.

As always, if anyone has any additions to the list, let me know in the comments box below and I’ll provide an update.

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Digital Preservation – An Industry Initiative to Develop Standards

The challenge of ensuring the long-term accessibility, reliability and authenticity of archived electronic records has been with us for some time, particularly in an industry where retention times can be in excess of 15 years…. sometimes for the marketed life of a drug or device product. There are various strategies to help overcome the problems of software, hardware and operating system obsolescence as well as media failure. However, this task is made even more difficult in an industry that uses so many proprietary file formats. In comparison, the retention of Microsoft office documents is child’s play!

Help could be on its way with the initiation of a Pharmaceutical Common File Format industry group, championed by digital preservation specialists Tessella. The group, currently with six companies represented, intends to explore the challenges involved in the identification and characterization of pharmaceutical-specific file formats. These are formats which are currently not dealt with particularly well by tools such as DROID. Identification and characterization is the first step to developing a strategy for preserving these formats, either by monitoring the availability of software to access the content or by migrating the content to a compatible, more stable file format.

Feel free to contact Tessella directly to get involved. The wider participation there is in this initiative, the more likely it is that the deliverables will be representative of the industry and will be of value.

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