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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British Standard BS 5454:2000 Withdrawn

The British Standard BS 5454 Recommendations for the Storage and Exhibition of Archival Documents has been in existence in one form or other since the late 1970’s. Throughout this period, it has been a fairly succint document (last revision contained just 25 pages) and has been primarily used to give guidance on archival conditions for long-term preservation, for example, museum conditions. In this respect, it has often been misquoted as a general standard for the design and operation of business archives.

The British Standards Institute has now withdrawn this standard, together with the associated guide PD 0024:2001, and have instead made available a Published Document PD 5454:2012 Guide for the Storage and Exhibition of Archival Materials (pub. March 2012). This new document is a more subsantial publication, being 76 pages, and really brings the previous standard up-to-date. Although it still has an emphasis on preservation of valuable documents – such as manuscripts – and the exhibition of such documents, it is now much more applicable in a business archive scenario. It also addresses storage of digital media.

The document begins with detailed guidance on the nature of documents and best practice for their storage and use. This includes topics such as environamental ccontrols for different media, protection against mould, infestation and pollution, environmental monitoring, environmental control, packaging and security. The guide then goes on to describe the repository building and measures that can be taken in the design and build of an archive facility. This section includes hazard avoidance, security, construction, environmetal stability, fire and water protection, load distribution, shelving and lighting, to name but a few.

I think this new publication is a more useful document than the old British Standard and has a much wider scope of application. However, care should be taken to avoid treating the content as a standard, expecting absolute compliance. Indeed, the cover warns “This publication is not to be considered a British Standard”. PD 5454:2012 can be obtained from the BSI Online shop (£244.80 non-member price / £122.40 member price).

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What is your Policy for Making a Record of Telephone Conversations?

It seems that most of our electronic communications automatically generate a record that we are able to capture – if we so choose – and manage in a records management system. It is now possible to implement procedures that capture and manage Instant Messages, web pages, and contributions to social media. But what are we doing about telephone conversations? Some industries routinely either record specific telephone calls or maintain a log or note of such calls and these become business records just like any other transactional record. The recent Barclays LIBOR scandal that has hit the City of London demonstrates the need to have a consistent policy, for the policy to be documented and for the policy to actually be followed by staff. Here is a transcript of the initial conversation between Paul Tucker, Deputy Governor of the Bank of England and the Treasury Committee (acknowledgement to parliament website):

Q320 Chair: Good afternoon, Mr Tucker. Thank you very much for coming to give evidence, and we are in fact responding to a specific request from you to do exactly that at the earliest opportunity. I note in the pieces of paper that have come through to us this morning that the Bank of England does not hold its own records or transcripts of any of these phone conversations. Why not?

Paul Tucker: I think many of these records do come from the Bank of England, but we have had to pull them together and check that we have got a complete set.

Q321 Chair: Do you keep records of your phone conversations?

Paul Tucker: We certainly keep records of all phone conversations where a note has been taken. The conversation with Bob Diamond was not a conversation that I made a note of or a private secretary made a note of. Sitting here, I greatly wish there were a note of it. The reason is these were completely extraordinary times where many of us, not only I, were rushing from meeting to meeting and making an enormous number of calls, taking an enormous number of calls, and it would be wrong to suggest otherwise than that the routine system of recording things was creaking.

Q322 Chair: So you did customarily record all your phone conversations?

Paul Tucker: In the normal course of business, we would make a note of material telephone conversations, yes.

Q323 Chair: Has there been any internal review of what went wrong here?

Paul Tucker: In terms of keeping a note of this conversation?

Chair: And the handling of this whole issue.

Paul Tucker: Not yet. It is something that I think we will come back to in due course when times are calmer again. We are still living through pretty well crisis conditions.

Few of us will ever be in a situation where we are giving evidence before a parliamentary committee, but we may well be in a situation where business conducted by telephone should rightly have been documented and those records incorporated into our standard records management programme.

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Should Clinical Trial Data be Regarded as Personal Data?

This question has been discussed heavily since the issue of the EU Data Protection Directive 95/46/EC back in October 1995. Over the years, there has been a concensus of opinion that patient records should be regarded as coming within the jurisdiction of data protection legislation because, even though the record is anonymized by the use of an abstract identifier, there exists the ability – via the subject log – to determine who the record relates to. However, I wonder whether recent EU proposals may open up this debate again?

The European Council has recently outlined some revisions to the initial draft Data Protection Regulation that was made available in January of this year. The revisions change the definition of personal data such that if it is deemed to be too burdensome to identify the individual, then the data should not be regarded as personal data. The proposed definition states that “if identification requires a disproportionate time, effort or material resources, the natural living person shall not be considered identifiable”. I can imagine that some might argue it would be too burdensome to follow the pathway from an anonymous case report form held by a clinical trial sponsor, through to the investigational site and then from the subject log to a natural person, that the CRFs should not be considered to hold personal data. Let’s watch this space!!

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