Case study-led agenda develops for TMF Europe

If you work with Trial Master Files, you might be interested to hear about IQPC’s TMF Europe conference. Now in its second year, this is highly interactive and case study driven. The agenda does away with your usual mix of classroom-style presentations and includes a live inspection simulation, people bingo, campfire round-table discussions, live debate and pub-style quiz! There will also be a keynote session from an EU regulatory agency on inspector expectations (TMF accessibility and availability). With an optional Cava tasting, what is there not to like!!

Thinking about implementing an eTMF solution but not sure what the issues are? Do have lots of questions about managing TMFs? This is certainly the conference for you. And in a great location too!

Please see IQPC’s conference website at http://www.tmfeurope.com for more details or view a draft agenda here.

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Training Course: Managing Electronic Records

This is a just a quick promo for a one-day training course that I am running with my colleague, Russell Joyce, on behalf of the Scientific Archivists Group. The course is aimed at anyone with responsibility for electronic records….. for those managing systems such as electronic trial master files or SharePoint-based solutions, those responsible for electronic records processes and policies, or those responsible for establishing electronic archives.

The Scientific Archivists Group (SAG) is focussed on management of records in a scientific research environment but the course content would also be applicable to other regulated industries.

The booking deadline is coming up in a couple of weeks so if this is of interest to yourself or a colleague, please make your reservation as soon as possible to ensure you get a place. The course is taking place just outside the perimeter of London’s Heathrow Airport – so great for accessibility – and is scheduled for Wednesday 15th June. For booking and further details, please see https://sagroup.eventhq.co.uk/mer. There is a discount for SAG members; if you are not currently a member, please consider taking up membership as the discount almost covers the membership fee.

 

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Wingspan eTMF

We are pleased to announce the addition of Wingspan eTMF to our list of featured advertisers. Wingspan – founded in 1996 by CEO Troy Deck – has been in the electronic document management business for many years, with its suite of DocWay products being very familiar to Documentum and SharePoint users (amongst others).

Wingspan eTMF – first released in 2009 – was developed in partnership with the life sciences industry. Refined based on feedback from daily use by thousands of users from around the world, Wingspan eTMF has been used to facilitate a number of successful health authority inspections from a variety of agencies.

Wingspan will be exhibiting at the upcoming 5th eTMF Summit, Arlington VA, USA (20-22 January 2016), with Kathie Clark, VP Product Management also presenting on development of an eTMF business case. Make time to catch up with Kathie and her colleagues if you are attending the summit. For more information about Wingspan eTMF, please see their feature HERE.

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Booking Now Open for SAG Conference (April 2016)

Just a quick note to mention that bookings are now being taken for the next Conference of the Scientific Archivists Group (SAG). This will be of interest to anyone who is involved in the management and/or archiving of scientific records, especially those working in the pharmaceutical, biotechnology and healthcare sectors.

For the first time, the conference will include parallel “clinical” and “pre-clinical” tracks, with topics that should be of particular interest to those specialist areas. So in the clinical track the sessions include an update on the TMF Reference Model and selecting an eTMF solution, whilst the pre-clinical track includes managing GLP/GMP samples and how to prepare for GLP/GMP compliance audits. We also have keynote sessions from the National Institute of Health and Clinical Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA). Added to this are updates from the two Special Interest Groups – Electronic Records and Good Clinical Practice – and various networking sessions (including drinks reception and gala dinner), and it all makes for a fabulous event!

This is going to be a sell-out event and ticket numbers are limited so please make sure you book early. The dates are 21-22 April 2016. The venue is the Crowne Plaza City Centre Hotel, Birmingham, UK. Prices go up by 15% once the Early Bird booking period closes and SAG members benefit from a 15% discount on the displayed prices. For further details, including the provisional agenda, prices, and booking process, go to the SAG website at http://www.sagroup.org.uk/events/2016conference.  Online booking is open at https://sagroup-2016.eventbrite.co.uk

Posted in Records management practice, Training

Get Ready for Electronic Document Management Conference

The Drug Information Association (DIA) have just released their Call for Abstracts for the upcoming Electronic Document Management conference in Leiden, Netherlands in May 2016, as follows:

DIA invites you to submit abstracts for this upcoming conference in Leiden, only a 20 minute drive from Amsterdam Schiphol airport. Join fellow experts and play a part in moving towards new and more efficient ways of managing documentation. How can we achieve systems that allow multidimensional reporting? How do we move from thinking based on individual sheets of paper, to an information matrix that approaches the topic from a needs-perspective?

View topics and details in the Call for Abstracts flyer and take the first step in becoming a speaker.

Please note: The deadline for submission of abstracts is 31 December so you need to act fast. It would be great to see some industry case studies on the agenda. Let us know the document management challenges you are facing and how you are tackling them. Topics that I am particularly keen to see on the agenda are:

  • eTMF and content authoring
  • Integrating eTMF and enterprise content/document management
  • Interoperability (e.g. eTMF with eTMF, eTMF with eDM, eTMF with data warehouse)
  • Big data, data mining (signal detection) and data warehouses
  • Interoperability and taxonomy/standardisation
  • CRO Integration of processes
  • Outsourcing and Infrastructure
  • Controlled vocabularies and reference sources
  • Approving content and documents electronically
  • Integrating electronic signatures into business applications
  • Long term digital preservation of electronic content
  • Compliance tracking, analytics and management reporting
  • eISF and investigator portals
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MHRA Comments on Records Retention

It seems that the latest submission from the MHRA on their GCP Forum has provoked a great amount of discussion and raised concerns amongst industry. What is it all about?

Well the MHRA have provided some clarification on the topic of retention of records. The wording in some of the applicable European Directives is a little ambiguous so the MHRA have tried to clear up this topic. They also provide some clarification about retention of electronic records, pointing out that “electronic records are acceptable under the regulations”. So far, so good.

However, the Forum post then goes on to discuss the digitisation of paper records, retaining in their place electronic copies. What appears to be causing most concern is the suggestion by the MHRA that irrespective of whether the scanning process produces certified copies in accordance with applicable regulatory requirements, there is an expectation that the original hard-copy records should be retained for a minimum of 5 years after completion of the clinical trial. They comment further that even after expiry of this 5-year period, there would be a requirement for “full verification that these data were complete, legible and verifiable as accurate copies of the originals.” And failure to do so would require production of the original paper records.

I fully understand some of the reasons why these comments are being made, due largely to the MHRA inspectors having come across some very poor practices with regards to document scanning. If they see poor quality scanned documents in an inspection, they are not going to be recommending that you destroy your originals! However, I find the whole tone of the comments disconcerting. And remember, there is NOTHING in the applicable regulations, directives or legislation that specifically requires retention of original records following production of a certified copy.

And therein lies the issue – are you producing a certified copy, per the requirements of the EMA and FDA? You see, if you are indeed generating a certified copy – an accurate and complete copy of the original document – there is no regulatory objection to you destroying the original records. I’ll say that again. If you have satisfied yourself that the digital copies of your original paper records meet the definition of the EMA/FDA for a certified copy, there is no regulatory requirement for you to retain the original documents.

A definition for a certified copy is provided in the draft ICH GCP Addendum:

“A paper or electronic copy of the original record that has been verified (e.g. by a dated signature) or has been generated through a validated process to produce an exact copy having all of the same attributes and information as the original.”

The document goes on to say:

When a copy is used to replace an original document, the copy should fulfil the requirements for certified copies”.

Notice the wording? It says that a certified copy can “replace” an original document. That doesn’t mean “keep hold of the original just in case” …. it means “replace”.

What about legal admissibility? No problems here either. If you are generating a certified copy and are destroying the original as part of your normal business process, a copy cannot be deemed inadmissible solely by virtue of it not being the original. The authenticity of the copy may be challenged but for a certified copy, you would of course have a documented process, audit trails etc to support you.

So what am I saying? That it is always OK to destroy originals following scanning? No, I’m not. But what I am saying is that our industry is already extremely risk-averse on purely administrative matters. For issues that have the potential to impact patient safety or product quality, being risk-averse is appropriate. But we’ve been encouraged over the last few years by the EMA and MHRA to follow a risk-adapted approach to the management of clinical trials, especially where patient safety is not a factor. Rather than starting from the assumption that copies will be poor quality and you should therefore retain originals just in case they are needed, let’s start from the assumption that you are generating acceptable, certified copies. Quality by design! So, assuming that you have a well thought-out and validated process for generating certified digital copies, and you have a quality management system that gives you assurance of the completeness, accuracy and trustworthiness of those copies, you should not be dissuaded from destroying the original records as part of your normal business practice. We need to develop high quality process and then have confidence in our processes and in our technology to help them deliver maximum efficiency savings.

[Also posted on LinkedIn Pulse]

Posted in e-records, Records management practice, Regulations, TMF | 1 Comment

US Safe Harbor Scheme Ruled Invalid

The Court of Justice of the European Union today ruled that the European Commission’s decision that the US Safe Harbour scheme provides an adequate level of protection is invalid. Their ruling states:

“In the light of the revelations made in 2013 by Edward Snowden concerning the activities of the United States intelligence services (in particular the National Security Agency (‘the NSA’)), the law and practice of the United States do not offer sufficient protection against surveillance by the public authorities of the data transferred to that country. ”

It further states:

” The scheme is applicable solely to the United States undertakings which adhere to it, and United States public authorities are not themselves subject to it. Furthermore, national security, public interest and law enforcement requirements of the United States prevail over the safe harbour scheme, so that United States undertakings are bound to disregard, without limitation, the protective rules laid down by that scheme where they conflict with such requirements”

Clearly, this has potentially huge implications for European legal entities who routinely transfer personal data to the United States for processing, including employment information, financial information or clinical trial data. United States entities can no longer be automatically considered “safe” for the purposes of data protection.

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