Why are Signatures Missing from the Average Office Computer Desktop?

Have you ever thought about the decision-making process for the purchase of office desktop software? I’ve never been involved in this activity so it is something I admit to knowing almost nothing about! However, there is one aspect that has intrigued me for a while. Let me explain.

The provision of office productivity software to all office-based employees is taken for granted these days. Certainly in the business sectors that I work, it is a given that every new employee will be given a computer (desktop or laptop, sometimes both) which has an office productivity suite pre-installed. This is more often than not Microsoft Office, which comprises a word processor (Word), a spreadsheet (Excel), a presentation package (Powerpoint) and electronic mail (Outlook) together with various related utilities. This is a significant cost to the employer; for a company employing 1,000 staff, they are spending around £5000,000 on desktop software. I see very little evidence of this purchase being justified…. what is the software being used for; are all components necessary; is the company getting value for money. Now, I’m taking a very simplistic view and I’m sure some of these discussions do go on but the fact is, it is taken as a given that everyone “needs” these products installed on their computer. And for the most part, I’d agree.

However, there is one significant component missing. We create documents electronically…. a report, a proposal, a letter. We create data files electronically….a budget, a costing proposal, an expenditure analysis. We create presentations electronically…. a conference lecture, a presentation to our department. And we use electronic mail to send all of these documents to our colleagues for input, information, review etc. The guys who have provided the tools to do all of this seem to have forgotten that a significant number of these documents then have to be signed once they have been reviewed and approved for use. Or at least, need some way of authenticating the origin and/or status of the document. So what do we do? Our desktop productivity suite does not include digital signatures so we have to print out the document and use a handwritten signature. Old-fashioned or what!!

I’m still struggling to understand why in the 21st century when we have legislation that supports digital signatures and we have technological solutions for digital signatures that have been tried and tested for years, we still don’t have the technology FULLY INTEGRATED into the desktop productivity suites we’re using and they’re pre-installed by our IT departments BY DEFAULT. So this is a plea to our IT colleagues. If you are spending upwards of £300+ on a desktop productivity suite for each of your staff, don’t miss one of the most vital components of the document life-cycle – review/approval. Let’s get the tools to keep our documents electronic across the whole of the life-cycle. When a large pharmaceutical company estimates the cost of obtaining one wet-ink signature from an external approver as $25 (printing, courier, processing, scanning), the cost of installing a digital signature solution pales into insignificance. Time for another paradigm shift??

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Migration Options for SharePoint 2013: Consider Your Options Carefully

This is the title of a blog posted recently on the AIIM website and I’d encourage you to take a look. The reason that I’m highlighting this link is because it is just so relevant given the presentation that I gave recently during a webinar run jointly with colleagues at Arkivum. Archiving requires the management and preservation of authenticity, integrity, reliability and usability of records over the complete record lifecycle. For this reason, we concluded that enterprise records management systems were probably not the most appropriate tool to consider for electronic acrhiving purposes. Just consider the migration needs not only for the documents but also for the attributes, transactions, audit trails and data dictionaries. The AIIM article highlights some of these issues in the context of attempting to migrate from SharePoint 2007 or 2010 to SharePoint 2013. Extrapolate those problems over a 15-25 year retention period and you’ll begin to imagine the difficulties!! If you are considering e-Archiving, ensure you do this as part of a comprehensive digital preservation strategy.

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Should Legislation Mandate Specific Minimum Retention Periods for Documents?

If we consider a variety of legislation on the statute book in the UK for example, it is more often the case that citizens and corporations are left to define their own retention period that is consistent with both the statute of limitations (Limitations Act 1980 in the UK) and any inspection or audit requirements. There is, for example, no mandated minimum retention period for personal financial records within the Finance Act but the legislation does provide for the possibility of an inspection by HMRC within six years of the end of the financial year. There is no mandated minimum retention period for documents that demonstrate compliance with the Race Relations Act 1976 but action cannot be brought once a period of six years has expired. Similarly, there is no mandated minimum retention period for workplace health assessment records within the Management of Health and Safety at Work Regulations 1999, but action cannot be brought once a period of six years has expired. There are exceptions to these general rules but explicit retention periods in legislation are usually consistent with the relevant period described in the Limitations Act.

Why is this relevant? Well last week, the rapporteur for the new draft Clinical Trials Regulation in the European Union (Glenis Willmott glenis.willmott@europarl.europa.eu) published her draft report on the proposals. The report includes 74 amendments to the draft regulation text, including a suggested amendment regarding retention times for clinical trial records (the trial master file). The original draft regulation stated the following:

 “Unless other Union legislation requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least five years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation.”

This provides adequate time for regulatory agencies to conduct inspections of both the sponsor documents and investigator site documents. Clearly, if the sponsor’s timeline for marketing authorisation application extends beyond this five year period, the retention time would be extended in order to support the application. However, that is a decision for the sponsor.

The draft regulation has now been amended as follows:

“The sponsor and the investigator shall archive the content of the clinical trial master file for an indefinite period of time after concluding the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation. If the sponsor is unable to archive the master file, it may be archived in the EU database.”

The rationale for extending the retention period to indefinite is given as:

“Should a sponsor come under investigation for misconduct, the clinical trial master file would be vital. Therefore the master file should be archived indefinitely unless national legislation states otherwise. The master file can be stored in the EU database if necessary.”

I believe there are several significant problems with this new burden, not least of which is outlined in my introduction…. an indefinite retention period should not be mandated by legislation.

1. The existing retention period (minimum of 5 years after clinical trial completion and longer if the trial data supports a marketing application) should be sufficient to support the identification of misconduct.

2. If the reason for an indefinite retention is to help identify misconduct, it is questionable why the revised text permits reversion to national legislation with a shorter retention period be followed in preference to an indefinite period.

3. Given that a significant majority of clinical research misconduct is practiced by the clinical trial investigator site and not the sponsor, it is not understood why the sponsor’s retention period has been extended to indefinite but the subject files (source records) are only retained ih naccordance with national legislation, typically 5-10 years. It is usually the source records which help to confirm the presence of misconduct by the investigator.

4. The suggestion that the sponsor may archive the master file “in the EU database” is unworkable from a number of perspectives. Firstly, existing EU Directives and ICH GCP make it clear that the sponsor is responsible for retention of the sponsor trial master file. It is therefore inconsistent to suggest that if the sponsor cannot achieve this (or chooses not to), they may store the master file with the EMA in an EU database. The proposed wording suggests that it would be acceptable for the sponsor to transfer custodianship of the master file immediately a trial has closed. Secondly, it took several years for the development of a consistent content, structure and format for the clinical study report. Given the huge scope of the trial master file, it will take an age to agree the content, structure and format for master files to be submitted to the EU database. And finally, it is not clear what the “EU database” is that will be storing the trial master files. If it is the same database that is described in Recital 52, this significantly broadens the scope of this database and calls into question the requirement for its contents to be publicly available. This would open up the whole content of the trial master file to the general public.

5. No distinction is made between industry-sponsored clinical trials and investigator-sponsored clinical trials. The implication therefore is that the investigator site will similarly be required to retain their trial master files for an indefinite period. The implications of this burden cannot be under-estimated, both for industry and for investigators. Such a requirement may drive more clinical trials away from Europe.

And finally, this critique would not be complete without also commenting on Amendment 59, proposed text for Article 53, paragraph 1. The original text stated:

“All clinical trial information shall be recorded, processed, handled, and stored in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable legislation on personal data protection.”

This is now stated as:

“All clinical trial information shall be recorded, processed, handled, and stored in the format of a clinical study report, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable legislation on personal data protection.”

The original wording referred to ALL clinical trial information in a wide variety of documents e.g. correspondence, monitoring reports, source data etc. However, the revised wording bizarrely suggests that all clinical trial information should be written in a clinical study report. Unless I’ve misinterpreted the text, this just doesn’t make sense.

If you are in agreement with my comments, I strongly urge you to read the draft report and submit a written response to Ms Willmott (glenis.willmott@europarl.europa.eu) as soon as possible.

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Update: MHRA GCP Guide Now Available in Electronic Format

Further to my posting in September to alert you to the availability of a new guide to Good Clinical Practice (GCP) from the MHRA, this guide is now also available electronically in Kindle format. Please note: it appears that currently the existence of this Kindle version is not highlighted on the MHRA website neither is it evident if you click on the link to purchase the guide. The purchase link only takes you to The Stationery Office (TSO) website to purchase a hard-copy version at £45.

To find the Kindle version, you need to go to the Amazon website and search for “good clinical practice guide” in the Books section. The search should reveal the hard-copy version (available at £42.75 / $85.00 plus p+p) but should also show the Kindle version at £32.06 / $59.99 (no postage fees!).

Don’t have a Kindle? Software is available to read Kindle books on PC’s, Apple devices (iPod, iPad and iPhone) and Android devices. If you prefer an iPad version, I believe that this is also being planned and should be published shortly. One of the advantages of the electronic version – other than not have to carry around a book that weighs 1.25kg – is that you can search easily for specific words and you can highlight and annotate sections.

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MHRA Publishes TMF FAQs

The UK MHRA have published a set of Frequently Asked Questions on the topic of Trial Master Files and Archiving. These can be found on the their online forum.

Readers who have purchased a copy of the recently published MHRA GCP Guide (the “grey guide”) will recognise some of the content on this new online resource. Not suprisingly, much of the content is drawn from the GCP Guide and so to that extent there are no great suprises here. However, it is reassuring to see the consistency of responses and to see the questions that the MHRA have chosen to include in this free resource. The questions posed are:

  • What is a Trial Master File (TMF)?
  • Is a TMF always required?
  • Can the sponsor and investigator TMFs be combined?
  • Can management of the TMF be subcontracted by the sponsor and what should be considered when using CROs?
  • How should the TMF be organised?
  • Is it necssary to have SOPs and standard indices for the TMF?
  • How should the TMF be stored and who should have access?
  • Should the TMF be kept up to date?
  • What is regarded as an essential document?
  • How should we deal with correspondence, in particular emails?
  • Is it acceptable for the TMF to be electronic?
  • We scan our documents for inclusion in the TMF. Is this acceptable and can the paper originals be destroyed?
  • Will access to the TMF be required during an inspection?
  • How long shuld the TMF be retained (archived) after the trial is completed?
  • Can the sponsor retain (archive) the investigators TMF?
  • Are there any requirements for the archive storage conditions?
  • How should electronic documents/data be archived?
  • Is there a need for an Archivist?

Are there any suprises in the content? Well, because the content is largely based on the GCP Guide, there were no huge suprises here. However, 2 points did jump out at me. The first was in relation to guidance on management of correspondence and in particular emails. Given the emphasis that the MHRA and other authorities have placed on producing certified copies of documents that are an “exact copy of the original with no loss of metadata”, it is still suprising to see the printing of emails to paper given as an acceptable option. A printout of an email cannot be a lossless copy. Where emails are to be retained electronically, the Outlook pst file format is given as the preferred format despite this not being suitable for long-term retention and being an extremely difficult file format to manage (e.g. searchability, navigation, file size). Portable document format (pdf) is also suggested as a suitable format but not the preferred one; I would question the rationale behind this recommendation and would suggest that PDF/A is the default file format for emails.

Secondly, I liked the structure given in the answer to question 4 (can TMF management be subcontracted). The MHRA have laid out what is effectively a great checklist to be used when studies are contracted out. This should help to avoid an misunderstanding regarding responsibilities for TMF maintenance, which systems are being used, and how documents are to be transferred between parties.

Thanks to the MHRA for another great TMF resource!

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TMF, eTMF, eTMF System…. What is the Difference?

One of the questions that I get asked repeatedly is what exactly is the trial master file (TMF). I represented this graphically a number of years ago, as follows:

Trial_Master_FileFor quite a while, industry thought that the TMF was just those documents listed in Section 8 of ICH GCP. However, many regulatory agencies – most recently the MHRA in their GCP Guide – have made it clear that the TMF is much wider in scope than this. The documents listed in Section 8 of ICH GCP are just a minimum list of essential documents. The TMF should also contain other trial-related records that “permit evaluation of the conduct of the trial and the quality of the data produced”. Industry can get assistance in determining what this constitutes by referring to the TMF Reference Model. There are also some supporting files that are generally considered to be outside the scope of the TMF but it should be noted that these files are still potentially subject to inspection. Examples include SOPs, training records and computer system validation files.

So what then is an eTMF and is this the same as an eTMF system? The answer depends on the scope of content that you intend adding to your electronic document management system. Whilst some regulatory agencies have indicated that their preference is to have a single system that holds the whole content of the TMF, this view is not  held by all agencies. Therefore, it is permissible for your TMF to be managed in more than one electronic system and in more than one paper system, or even a hybrid of both (i.e. some in paper and some in electronic). There does seems to be a trend towards having a single system but the critical issue is that your SOPs must define which system(s) (paper and electronic) the TMF content is held in. It is also advisable to avoid having content duplicated in paper and electronic format. In other words, if you have invested in an eTMF system to manage some or all of the TMF content, ensure your SOPs define this as the official repository for that content and any hard-copies as temporary convenience copies only (though best to avoid hard-copy as much as possible!). This will take away any obligation to do reconcilliation and QC between hard-copy and electronic. Where team members need hard-copy to do their job, I’d advise generating these convenience copies from the official electronic source, bearing an appropriate watermark that identifies the source.

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Do You Have a Secure Chain of Custody?

The recent news O2/IBM has misplaced a data tape containing unencrypted personal data just emphasises to me the need to have a secure chain of custody for our data and records. This means ensuring that when records are passed from one custodian to another across an end-to-end process, we have secure hand-offs and an audit trail that captures critical characteristics of each hand-off. Whilst this provides no guarantees that records will not be lost, I think it puts more focus on the hand-offs and as a result improves the robustness of the overall process.

Of course, the other aspect of this story is why unencrypted data tapes are being used for personal data. So, why don’t we take a look at our own records management chain of custody? Are there appropriate security mechanisms in place? When you hand over data tapes to your off-site provider, what security processes are in place at hand-over, during transit, and at the storage location? Is there compliance with pertinent data security standards, for example ISo 27001 ‘Information Security Management’. And have you considered the need for data encryption before hand-off to a third party?

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