The World Slowly Wakes to the Reality of TMF Requirements

Perhaps my title is somewhat harsh but I perceive more than a little frustration in the announcement today from the MHRA that they are revising their definition of critical inspection findings to include cases “where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations“.

It seems like an age that consultants like myself and other experts have been telling industry that once a clinical trial is closed-out, no matter how wonderfully the trial was completed the only artifact that is left are the trial records….. the trial master file. This forms the basis for GCP inspections i.e. to demonstrate that all applicable regulations were complied with and that the data generated during the study can be trusted as being accurate and complete. So, maintenance of a trial master file is not just a case of filing away a set of documents and ticking them off some sort of inventory list. The trial master file must “tell the story” of the clinical trial….. how the trial was conducted and how decisions were made, for example. And when it comes to the time for an inspection, the TMF must be a complete and accurate record of the facts.

In amending the definition of criticial findings to include the unavailability or incompleteness of the TMF, the MHRA are raising the stakes. TMF management is not a process that should be considered a low priority administrative task but a criticial activity that is central to GCP compliance. And increasingly, TMF vendors are coming to realise that an eTMF is more than just a repository for PDF files; it is a critical tool to assist in trial conduct and trial management. I don’t think it will be too long before other regulatory agencies follow the MHRA’s lead on this.

About Rammell Consulting: We are a specialist records management consulting company, providing a range of consultancy, training and education services to the life sciences/healthcare sector. Topics that we advise on include the trial master file, electronic archiving and digital preservation. Please refer to our website for further information. Our Introduction to Records Management training module takes place on Thursday June 12th in the UK (last few places remaining).

Posted in Compliance, Records management practice, Regulations, TMF | Tagged , , , | 2 Comments

Training for Records Managers & Archivists

It is not often that I use my blog to promote meetings, conferences etc but I’m going to make an exception today! For those records management professionals working in the life sciences, there are few events that provide training specific to our sector. We can pick up general principles from organisations such as ARMA, AIIM and IRMS but where do we go for training that is specific to the issues we face in our work on a day-to-day basis?

Well, if you have not attended one of the Scientific Archivists Group conferences before, I recommend you take a look. Although the name of the association includes “archivist” it is actually much broader than that, meeting the needs of all records management professionals working in the life sciences, particularly focussing on those operating under GLP, GCP, GMP, etc. The finishes touches are just being made to the agenda of their next conference and bookings are now being taken.

The preliminary agenda can be viewed online – where bookings are taken also – and it includes:

  • electronic archiving solutions
  • archiving electronic mail
  • issues for the archivist when an R&D site closes
  • a non-commercial viewpoint of clinical archiving
  • quality and compliance issues for document digitisation (scanning)
  • cloud computing (case study)
  • health and safety
  • electronic signatures
  • document scanning (case study)

What a varied programme! And for £500 (12% reduction for SAG members) you get:

  • 2-day conference programme including all refreshments
  • 2-nights bed & breakfast accommodation in Nice, France
  • complimentary drinks reception
  • conference gala dinner
  • networking opportunities

Personally,  I think this is great value for money and would highly recommend attendance.

For staff who are fairly new to the industry and to records management, you may awant to consider our new 3-day training programme too which covers the full spectrum of records management principles, going back to basics.

Posted in Records management practice, Training | Tagged , | 1 Comment

Fire Destroys Argentine Banking System Archives, Killing 9

rammellel:

Another Iron Mountain Incident

Originally posted on mediachecker:

February 6, 2014

While we are sure it is a very sad coincidence, on the day when Argentina decrees limits on the FX positions banks can hold and the Argentine Central Bank’s reserves accounting is questioned publically, a massive fire – killing 9 people – has destroyed a warehouse archiving banking system documents. As The Washington Post reports, the fire at the Iron Mountain warehouse (which purportedly had multiple protections against fire, including advanced systems that can detect and quench flames without damaging important documents) took hours to control and the sprawling building appeared to be ruined.

The cause of the fire wasn’t immediately clear – though we suggest smelling [Christine] Fernandez’ hands…

We noted yesterday that there are major questions over Argentina’s reserve honesty

While first print is preliminary and subject to revision, the size of recent discrepancies have no precedent. This suggests that the government may…

View original 786 more words

Posted in Uncategorized | Leave a comment

New Records Management Training Programme Launched

We are pleased to announce the launch of a new introductory training programme for records management and archiving staff, in conjunction with Heath Barrowcliff Consulting Ltd. This is comprised of three 1-day modules spread across a year. At only £250 (plus VAT) per day, this represents excellent value for money. We also provide a £50 discount for delegates attending the whole 3-day programme, making completion of the programme only £700 (plus VAT). The curriculum across the 3 modules covers all of the fundamental principles that a records management or archive professional needs to have knowledge of, at an introductory level. Our focus is on colleagues working in life sciences regulated environments (e.g. GLP, GCP, GMP), though a significant proportion of the content would be equally applicable in other sectors too. So, if you are a new archive assistant, archivist, document administrator, records manager or in another similar role and are looking for a training programme that covers the full scope of records management activities, this is the programme for you! Or perhaps you have a new member of staff in your organisation that could benefit from such a programme, please get in touch.

Our course venue is located adjacent to London’s Heathrow Airport so is great for transport links either within the UK or for delegates flying in from outside the UK. Our venue also provides overnight accommodation (booked separately by delegates) if needed, with prices from just £65/night. Our start time of 09:30am allows for delegates travelling to the venue on the morning of the course.

Full details of our training programme can be found at http://rmtrain.eventhq.co.uk/ and are also summarised below:

Module 1 – Introduction to Records Management and Archiving (1-day) This module will provide an overview of the fundamental principles of records management and archiving, including framing the subject in the context of the life sciences regulatory GxP environment. The content of this module will include:

  • What do we mean by ‘records management’?
  • Why is it important to manage records?
  • The legal and regulatory framework for archiving
  • Responsibility for records management and archiving
  • The records management lifecycle/continuum
  • The challenges to good practice
  • Benefits of adopting good practice

The first module is scheduled for Thursday 3rd April 2014. If this date is not convenient, contact us to be placed on the waiting list.

Module 2 – The Archivist and Archive Management (1-day) This module will build on the content of module 1 and will provide training on many of the practical aspects involved in running a life-sciences regulated archive. The content of this module will include:

  • The regulatory context (key pertinent GxP regulations)
  • The importance of archiving (evidential value, historical value, operational value, etc)
  • The role of the archivist
  • Managing physical records (paper, wet-tissues, samples and other media)
  • Managing on site archives
  • Managing off-site archives

Date: to be confirmed (July)

Module 3 – Managing Electronic Records (1-day) This module will refer to some of the principles covered on modules 1 and 2 that define the framework for managing electronic records. However, the primary focus will be on content that is specific to the management of digital records. The content of this module will include:

  • Are electronic records any different from physical records?
  • The concept and value of metadata
  • Shared network storage
  • Electronic content management systems
  • Managing electronic mail
  • An introduction to digital preservation

Date: to be confirmed (September)

Posted in Records management practice, Regulations, Training | Leave a comment

The Multimedia TMF Becomes a Reality

The clinical records management community is currently enjoying an interesting debate regarding the need for interoperability standards for electronic trial master file (eTMF) content. The need for organizations to efficiently exchange documents and metadata between systems is becoming increasingly critical, especially so when studies are outsourced to a CRO who uses a different eTMF solution to the one being used by the trial sponsor. The requirement also comes fro mthe exchange of content with the investigator site, And so far, the debate has been about exchanging documents. Not for much longer!

The Indian Ministry of Health & Family Welfare Food & Drug Administration (New Delhi) has recently issued an order that mandates the collection of certain trial records in audio-visual format. Order GCP/20/SC/Clin./2013 DCGI (19-NOV-2013) requires that in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed content process, including the procedure of providing information to the subject and his/her understanding of such consent, is required to be done, whilst adhering to the principles of confidentiality. The audio-visual recording will form part of the trial record at the investigator site (the investigator site file) and should be preserved. This new order is applicable with immediate effect to any new subjects to be enrolled in all clinical trials in India, including global clinical trials (i.e. where the sponsor is located outside India).

Firstly, let’s touch on the subject of confidentiality and then we’ll move on to records management issues! It will be interesting to see how an audio-visual recording of an informed consent process can be made such that the study monitor can view evidence of the informed consent but without compromisng subject confidentiality.

So let’s think about the records management issues. How will the recording be made? Presumably, with smartphones and digital cameras so prevalent, the recording will be captured digitally. What format will the files take? How will they be transferred from the recording device? What storage medium will they be transferred to that is suitable for archiving? Will the recording and transfer process be validated? What will happen in poorer, rural areas of India where digital capture might not be possible? Will recordings be made on video tape….. what format?

I think many of these questions can be answered with relative ease but they need to be addressed by the sponsor when the study protocol is being developed. Responses to these questions should not be made by individual investigator sites in reactive mode to avoid inconsistent, non-validated processes being adopted.

 

About Rammell Consulting: We are a specialist records management consulting company, providing a range of consultancy, training and education services to the life sciences/healthcare sector. Topics that we advise on include electronic archiving and digital preservation. Please refer to our website for further information.

Posted in Document Storage, e-records, Regulations, TMF | Leave a comment

How to Apply a Risk Based Approach to Records Management

The European Medicines Agency (EMA) has recently published its final reflection paper on risk based quality management in clinical trials, reference EMA/269011/2013, 18 November 2013.The management of trial records is barely mentioned in the paper but I took away a few principles that could be applied to clinical records management. Please note that, as always, these are my own personal views and do not ncessarily represent the viewpoint of the EMA!

The paper says:

“The current manner in which some elements of a quality system are implemented by sponsors and their agents (CROs etc.) is generally acknowledged to be time-consuming and constitutes a major proportion of the cost of development of medicines. In addition, the ICH GCP guideline was finalised in 1996 when clinical research was largely paper based, but the available technology and the approach to the conduct of clinical trials has evolved considerably in the meantime.”

I liked the fact that ther EMA is acknowledging the short-comings of the ICH guidelines with respect to its application in the 21st century. We need to be identifying more opportunities to introduce process efficiencies and avoid the temptation to use regulations as an “excuse” to be overly cautious. The EMA consider industry to be generally risk-averse, stating:

“Current practices in clinical research are not proportionate to risk nor well adapted to achieving the desired goals. The origins of the problem are multifactorial and include: risk aversion – society and its institutions (public and private) is increasingly risk averse, often with little appreciation of the actual or relative risk of different activities, leading to imbalanced or disproportionate risk mitigation”. The rsflection paper then goes on to say:

“Since perfection in every aspect of an activity is rarely achievable or can only be achieved by disproportionate allocation of resource, it is necessary to establish a risk based quality management system for which the ultimate principles are reliability of the trial results and the well being and safety of trial subjects. This system is based on identification of trial priorities and mitigation of the significant and serious risks and establishing tolerance limits within which different processes can operate.”

What this is saying to me is that we need to identify and assess the risks involved in developing processes for managing trial master file content but we then need to manage those risks in the light of all of the other risks involved in running a clinical trial, most of which have a much greater impact on the well-being and safety of trial subjects. We tend to put far too much effort and resource into developing high-quality records management processes and systems when perhaps that level of resource is not justified.

Don’t get me wrong, I’m not suggested we simply “lower the bar” and aim for poor quality systems and proceses but that we carry out a proper risk assesment when we “do” process re-engineering. And the EMA support this, recommending that we conduct a “Risk assessment requiring knowledge and understanding of what really matters for the establishment of priorities and the identification of risks: what may go wrong? What is the probability (chance/likelihood) of the occurrence of a negative outcome? What, in particular, would be the impact on trial subjects’ rights/well-being/safety and/or on the reliability of the trial results?”.

So let’s take as an example the required level of QC necessary when scanning a paper document, importing the PDF into an eTMF, indexing the electronic file and deciding whether to keep or destroy the original paper document. Is the process we define proportionate to the risk? Will errors likely result in an adverse effect on subject well-being and safety? Are there opportunities for errors to be mitigated against. Let’s have a “reality check” and ensure we’re taking a reasonable risk-based approach with records management as well as for trial conduct and study monitoring.

About Rammell Consulting: We are a specialist records management consulting company, providing a range of consultancy, training and education services to the life sciences/healthcare sector. Please refer to our website for further information.

Posted in Regulations, TMF | Leave a comment

UK Government Seeks to Prevent Proposed Amendment to Clinical Trial Regulation

If you’ve been following the ongoing debate regarding the proposed European Clinical Trial Regulation (see previous posts on this site), you will know that the text currently before Parliament is proposing (a) that Trial Master File content be held and maintained only in electronic form and (b) is retained for an indefinite period. I have corresponded with the UK Government on this issue and the initial responses are promising.

The Rt Hon the Earl Howe, Parliamentary Under Secretary of State for Quality confirms that he is concerned with these amendments and that the requirement to hold the TMF in electronic format and to be retained indefinitely “would impose a disproportionate burden on researchers”.

The amendments will be examined during negotiations between the European Council of Ministers and the European Parliament, and the Government “will try to prevent this amendment from being in the Regulation”. Departmental officials have already discussed a number of amendments that impose unnecessary burdens, including this amendment, with MEPs, including the lead MEP for the Regulation. Officials are also in contact with the Presidency of the Council (currently Lithuania) and other member states about these amendments.

Action plan: If you are an EU citizen and are concerned about the potential imposition of an obligation to maintain all trial master file records in electronic format for an indefinite period, please write to your MP and to your MEP, making reference to Amendment 223, Article 55, Paragraph 1. MPs, MEPs and Ministers need to hear a consistent message on this topic.

Posted in Compliance, Regulations, TMF | Leave a comment