Rammell Consulting Ltd to Close!

As many of you know, I have been a freelance records management consultant operating as Rammell Consulting since 2004. The last 14 years as a freelance worker have been very exciting times (mostly!) and has given me the opportunity to work with very many fabulous work colleagues, many of whom I also consider as my friends. It is therefore with a little sadness that I’m bringing this part of my career to a close. I feel that now is the right time in my life and in my career for a slight change in direction.

I have accepted as permanent, full-time position with Phlexglobal Ltd as Director, Client Solutions (effective 18 February 2019). I am very excited about this change. My new role gives me the opportunity to continue providing records management consultancy alongside a team of professional colleagues at Phlexglobal….. helping companies to raise their standard in document management.

I will continue as a Board Director with HSRAA and will continue to be an active member of the TMF Reference Model project (though not as a Steering Committee member).

Here’s to the future!! Exciting times ahead!!

Eldin.

[This website will close down in the next few weeks]

EMA Publishes TMF Guidance

After a lengthy consultation period and delays – mostly caused by Brexit! – the EMA has published its long-awaited guideline: “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)“. This replaces the previously published draft guidance and reflection papers on this topic.

Although a guidance document rather than mandatory rules, it comes into effect on 6th June 2019. However, I’m sure most will be taking efforts to ensure the guidance is adopted as soon as possible!

The guidance clarifies many of the topics that industry has been struggling with and discussing recently, including certified copies…. certified copies can be used whenever copies are used instead of originals but copies must be certified copies if they “irreversibly replace originals”.  There is also guidance regarding archiving of audit trails in section 6.

The EMA have also published revised “Questions & Answers” on GCP topics, including the Trial Master File. You can read the Q&As here.

In need of guidance, support, training, consultancy? Please get in touch to discuss further.

TMF. ISF. What’s the difference – Part 2

This post continues the discussion regarding the differences between the TMF and ISF (or Investigator Site File). Several years ago, I created a pictorial representation of the TMF to illustrate that the TMF was more than just the minimum list of essential documents that are identified in ICH GCP Chapter 8. It seems that another picture might help here too.

So this shows what the TMF is comprised of. It includes TWO sets of documents: the sponsor TMF and the investigator TMF.

It is interesting that industry has developed a separate term for the investigator TMF, namely the ISF or Regulatory Binder, though not for the sponsor TMF. However, it is worth noting that neither ‘Investigator Site File’ or ‘Regulatory Binder’ are recognized terms in ICH GCP, FDA Code of Federal Regulations or European Directives or Regulations. The EMA draft guidance on GCP compliance in relation to the trial master file that was circulated in 2017 states that the investigator TMF is “often referred to as the Investigator Site File (ISF) or Site Master File (SMF)” but also reinforces the point that the TMF is actually both sets of documents. The MHRA GCP Guide refers to the TMF as being composed of a “sponsor file” and an “investigator site file”…. in other words, the TMF is NOT the sponsor file….. it is BOTH sets of files.

Unfortunately, we’re often seeing articles published, comments made online or people presenting about the TMF and they use the term “TMF” as if it just refers to the sponsor essential documents. For example, they refer to “the ISF and the TMF”. “Is this such a big deal?” you might ask. Well, the continued misuse of the term TMF to mean just the sponsor file has led to significant misunderstanding. For example, many colleagues mistakenly believe the “TMF Reference Model” does not include the contents of the ISF because they equate the term “TMF” with just the sponsor records! Or site staff do not get involved with conferences and other meetings that are promoted as “TMF” events because they don’t perceive the relevance. See how easily these misunderstandings can arise? So, if you read material or listen to colleagues talking about “the ISF and the TMF”, you really want to ask questions about what is meant. It is a little like saying “I travel to work either by car or by a motorized vehicle”. A car is a subset of motorized vehicle so the statement doesn’t make any sense! Similarly, the ISF is a sub-set of the TMF so it doesn’t make sense to say “the ISF and the TMF”; you mean “the ISF and the sponsor TMF”!!

So, now that we’ve cleared up the terminology, what about the content? Well, take a look again at the graphic.

There’s a lot in common between the investigator TMF (ISF) and the sponsor TMF. As much as 90% of the documents found in the investigator TMF are also found in the sponsor TMF (these can be identified in the TMF Reference Model by filtering on columns N – Q). Despite this overlap, the two parts of the TMF must still be treated as two separate sets of documents, one managed by the sponsor and one managed by the investigator. This point was specifically reinforced in the recent revision to ICH GCP. However, the sponsor TMF also includes a very large number of documents that are not held by the site. In addition, the investigator TMF (ISF) also holds content that the sponsor does not hold. It is important to note that there is not an expectation that the sponsor’s TMF hold everything that is in the investigator’s TMF. ICH GCP identifies specific documents that must be in both (see Chapter 8), but otherwise, there must be justification and a good rationale for transferring site documents to the sponsor, especially in the light of data protection legislation such as GDPR. Finally, the site also holds the subject’s medical file or medical notes. Some of these will be source data and filed in the investigator TMF (ISF) but others are not needed in the TMF and must remain in the medical notes in accordance with relevant regulations.

Just for information, a project is currently ongoing under the auspices of MAGI to create a comprehensive list (or reference model) of documents that comprise the investigator TMF. As agreed between MAGI and the TMF Reference Model Project, once final, the TMF Reference Model will be updated to include all of this new content.

Feel free to get in touch if you have any questions or need assistance in implementing or interpreting TMF regulations.

nb. For the avoidance of doubt, whilst I am a member of the TMF Reference Model Steering Committee, this is posted as a personal opinion and not as an official representative of the TMF Reference Model project team or Steering Committee.

TMF. ISF. What’s the difference?

Over the last few days I’ve been seeing a few posts on LinkedIn that have been getting me a little frustrated. The reason? Poor use of terminology! Let me explain.

The Trial Master File – or TMF – is defined by the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guideline as being “those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.” There is something really important to note here. The TMF includes not only the records generated by and managed by the trial sponsor. It includes the records generated by and managed by the investigator. They are held separately from the sponsor documents but they’re still part of the TMF.

We sometimes use different terms for the investigator-managed records…. typically the Investigator Site File or Regulatory Binder. But listen up: they are part of the Trial Master File!! So, when you hear people talking about the TMF or when read guidance about the TMF, it is not just referring to the sponsor essential documents, it includes the ISF too.

Why is this important at the moment?

An industry group has developed a reference model for trial essential documents over the last 9 years called the TMF Reference Model. It was created with the full scope of the TMF in mind…. in other words, it includes not just sponsor essential documents but also investigator essential documents. Yes, that’s right! The TMF Reference Model already includes the ISF. It doesn’t just contain 2 site documents (the subject log and source data)….. it includes them all! It is not called the “Sponsor TMF Reference Model” or “ISF Reference Model” because that’s not the terminology that ICH GCP uses. ICH GCP refers to both of these components as “the TMF” so that’s what the reference model is called! I’m going to make this absolutely clear here so there can be no ambiguity. If someone tells you the TMF Reference Model does not include ISF documents, they’re wrong. Just take a look for yourself. Download the Reference Model here: https://tmfrefmodel.com/resources/. Open up the spreadsheet and take a look at column O. Where you see an “X” in the cell, these are ISF documents for trials on medicinal products. Look at column Q. Where you see an “X” in the cell, these are ISF documents for trials on devices.

So, here’s the next question. Is the TMF Reference Model perfect for the ISF essential documents? No it is not. This is recognised by the project team and one of the things we’ve committed to do is to get it more closely aligned with the requirements of the site. For example, for each artifact in the model we list individual document types that correlate with the definition and purpose of the artifact. These are currently mostly focused on the sponsor’s needs but it would not take a great amount of effort to also include specific site documents. A separate initiative (NOT part of the TMF Reference Model!) is current embarking on a project to create a completely separate ISF Reference Model. An initial draft has just been published and I can say with confidence that EVERY document is already included in the TMF Reference Model with full classification. So I ask myself, why is a completely separate reference model being created for Investigator Site Files when we already have a Reference Model that includes this…. it just needs improving. I also ask myself, which scenario would it be better to have: a single TMF Reference Model that meets the needs of both the sponsor and the site, or sponsor and site using two different models, with different terminology, different filing structure, and different metadata? Surely a single reference model would support efficient information exchange between sponsor and site and ensure we’re aligned with the way we name and file our documents?

Recent surveys indicate the TMF Reference Model is used on over 80% of clinical trials. The TMF Reference Model has been downloaded over >10,000 times from the TMF Reference Model website. Let’s work together to make this work as effectively for sites as it does for sponsors. How? Join the team and make it work!!

Need help developing your TMF processes and systems? I’ve worked on over 30 TMF projects. Give me a call! I’m here to help.

nb. For the avoidance of doubt, whilst I am a member of the TMF Reference Model Steering Committee, this is posted as a personal opinion and not as an official representative of the TMF Reference Model project team.

Do You Have Records Management Problems?

If you look through my blog posts and LinkedIn updates over recent years, you’ll be forgiven for thinking that all I do is support pharmaceutical companies with their trial master files (TMFs). It is true that this has taken up a significant proportion of my consulting time in the last 5-7 years, largely because of the heightened focus on these records by regulatory authorities. And it is always enjoyable to work with my TMF colleagues…. we joke that “TMF” actually means “Too Much Fun”!

However, I’d like to take this opportunity to remind you that we do much more than this! Let’s run through the scope.

In terms of the industry sectors that I support, my main experience and expertise is in health sciences…. so that is the pharmaceutical and biotechnology industry and other organisations that work on health, medical devices and medicines development. However, I also have experience in other sectors, such as financial services, education and engineering services. Many of the records management principles that are applicable in health sciences are transferable to other sectors.

What aspects of records management do I support? I guess the right question to ask is what aspects of records management do I NOT support! I actually cover most, and this would include:

• Policy development, for example: records management policy to comply with GDPR and other requirements; legal hold policy to prevent the inappropriate destruction of records during litigation or other disputes; IT acceptable use policy; employee exit policy to ensure the orderly management of records prior to employees leaving the company. Do you have all of these in place?
• Process development, for example: processes to support the identification, classification and correct disposition of records; processes to support creation and management of an archive (on site, off site or digital); optimisation of record keeping processes in specific business functions; alignment of record keeping processes with applicable regulatory requirements to ensure compliance and efficiency.
• Record classification, including the development of taxonomies that support effective management of records in the business, in records centres, in archives and that support defensible destruction. Associated with this is the review and/or development of records retention schedules…. having in place an approved document that describes how long specific types of records are to be retained for (for most companies, this is a requirement of GDPR).
• Training, including development and (if needed) delivery of training to support your records management policies and procedures, record clean-up days, GDPR requirements.
• Strategy development, providing advice and support in areas such as deployment of electronic signature technology, organisational models for records management support, outsourcing of record keeping activities, and risk management.

And the list goes on! In short, if your organisation has records management issues that you are struggling to manage because of a lack of experience, expertise or resource, please reach out to me. I’m here to help!

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