British Standard BS 5454:2000 Withdrawn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The British Standards Institute has now withdrawn this standard, together with the associated guide PD 0024:2001, and have instead made available a Published Document PD 5454:2012 Guide for the Storage and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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TMF Reference Model Revised

The Trial Master File (TMF) Reference Model consists of standardized taxonomy that outlines the clear definition and organization of TMF content using standard nomenclature. This model, developed by a working group of the DIA Document Management Special Interest Area Community (SAIC), is a reference for the industry and should not be considered mandatory, but rather as an opportunity for standardization across the industry. The TMF Reference Model can be adapted equally to an electronic or a paper TMF.  It does not endorse, nor by design, require, any specific technology for application.  The model can be downloaded HERE.
The TMF Reference Model presents a consensus position of the TMF Reference Model Team regarding the content of the TMF to include all essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced, in accordance with regulatory requirements, industry opinion and best practices. The TMF Reference Model team is composed of approximately 274 representatives from more than 165 bio-pharmaceutical companies, contract research organizations (CROs), consultancies, technical vendors, industry groups, healthcare, academia, not-for-profit / NGO and regulatory agencies.

V1.0 of the TMF Reference Model, first released in June of 2010, was updated in February, 2011 (V1.1) and again in December, 2011 (V1.2), based on feedback provided as the model was widely implemented.

Who Benefits from the TMF Reference Model?

  • Biopharmaceutical sponsor companies of any size, both commercial and institutional, involved in clinical trials.
  • Clinical study team members, including trial and data management, clinical supplies, biostatistics, etc.
  • Contract Research Organizations and vendors supporting TMFs.
  • TMF Consultants.
  • Site staff, including investigators and coordinators.
  • Regulators challenged with varying TMF terminology and file structures, which create inefficiency and a higher degree of variability during sponsor audits

V2.0 includes additional details for Investigator Site Files, Device Studies, Investigator Initiated Studies, and Process-based metadata.

You can participate in discussions related to the TMF Reference Model by joining the LinkedIn group.

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TMF Reference Model Gains Momentum

The Trial Master File Reference Model (TMF RM), a supported initiative through the Document and Records Management SIAC of the Drug Information Association (DIA) is a standard reference for the contents of a Trial Master File. First published in 2010, it is a single, unified interpretation of the regulations and best practices and was collaboratively developed through a volunteer effort that includes more than 150 companies.  The TMF RM is free and available here.  Version 2 (due mid 2012) will include additional details for Investigator Site Files, Investigator Initiated Studies, Process-based Metadata and Device Studies.

Survey Monkey:

A quick online survey has been designed by members of the TMF Reference Model team to provide valuable insight into Trial Master File practices, both paper and electronic, to identify common problem areas, assess changes in practice and reveal opportunities for improvement. All respondents who complete the survey and provide contact information will be provided with the survey results. This will be a valuable industry tool so please do click on this link and complete the survey by June 1, 2012.

Disclaimer:  In accordance with the DIA Volunteer Code of Conduct, no volunteer shall use any information provided by the Association or acquired as a consequence of volunteer’s services to the Association in any manner other than in furtherance of his or her volunteer duties with DIA.  Volunteers are expected to act at all times in the best interests of the Association and not for personal or third-party gain or financial enrichment. DIA reserves the right to reproduce, license, sell, display, and distribute copies of materials posted to the DIA website, in any medium or technology (including online) consistent with DIA’s non-profit and tax exempt purposes.
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Will ePub or HTML5 Be The New Standard for Electronic Records?

As an industry, I think records managers and archivists have generally welcomed the emergence of PDF and PDF/A as a standard for the creation and preservation of documents. At last we have a format that enables us to view documents as they were originally intended to be viewed on a wide variety of platforms. In addition, the problems of software obsolesence have perhaps been virtually wiped away with the availability of PDF/A. However, even PDF presents certain problems, most notably with the ability to conveniently view documents on portable devices such as smartphones, iPADs and e-Readers.

I have just read a really thought-provoking article on the AIIM website by Serge Huber who suggests that PDF may need to make way for a new document format which is closer to HTML5 and EPUB3. I won’t attempt to summarise Serge’s article here; click the link to read it for yourself. As records managers and archivists we need to understand what the limitations of our current document formats are. We also need to try to understand where advances in technology may be leading us so that we are prepared when new file formats are thrust upon us. And perhaps even be there encouraging our organizations to migrate to these new formats?

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DIA EDM Corner Has Moved

This is just a quick notification that as a result of restructuring of the DIA (Drug Information Association) website, the link to the EDM Corner has now changed. The EDM Corner contains links to Trial Master File Reference Model and also to the draft Framework for the Destruction of Paper. If you have not already done so, please update your browser bookmarks with this link.

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