Clinical Trials & the TMF 101 - Blog 3: Paper vs Electronic, why it is more than a DMS

Introduction

Awww it warms my heart you came back to read the third blog. I hope you are finding these helpful, don’t forget to send any of your feedback or questions to rtjones@phlexglobal.com. We are always happy to answer your questions or just have a general chat.

In today’s tale of excitement and suspense we are talking about the differences between Paper and Electronic TMFs as well as the similarities they share. We will also be answering that age old question “Why can’t we just use a document management system?”

It doesn’t grow on trees you know

So we spoke in the previous blog, What is this TMF you speak of?, how the TMF is a set of documents collected over the course of the trial, from the initial setup all the way to close out. This is something that can be 9 months or 5 years. I also spoke about how the number of documents can reach dizzying heights in regards to what is collected and stored.

For those of you new to this industry you may not realize this, but you know those grey metal filing cabinets, or those really old wobbly shelves kept in a locked room? That is where the TMF used to be kept. All of those documents had to be stored somewhere and it had to be in a central place which had at least some level of security. What this ultimately meant was there was a room designated as document storage for the purpose of live in use data.

Give that a second to sink in though, every single piece of paper collected over the life of a study was kept in one room, thousands and thousands of pages; how big did these rooms need to be? Did people have to build or assign more rooms as more studies went live? What about backups? Fires, floods, earthquakes, these are not common but could happen, what would happen then? These are questions and items on a risk assessment that were reviewed all the time as they were genuine concerns and in reality, there was, and still is, no true answer. Keeping this paper is extremely expensive and cumbersome.

Its at this point you are probably thinking, “Wait a second, I am sat at home right now, I am part of a global team spread out all over the world… how do you access a document locked up in a room somewhere at the office when you could be hundreds of miles away?” Well, you don’t, you can’t access the information easily, and also if you need to submit something, you can’t just walk down the corridor to drop it off. What this means is if you need to view a document, you have to contact someone in the office and ask them to send you an authorized copy, you look at the copy, then destroy it, you can’t have random copies floating about, can you. And submitting, well the official answer is: you get the document, you let the central office know, you prepare shipping, and you send off through recorded mail… the unofficial answer to this I have seen is: you go see your friend who is going to the central office soon and ask them to pop it into their hand luggage and drop it off. Yea. Not ideal, is it.

Granted paper has its benefits, it is physical, it is very simple in that way. The document is either there or it is not, and when it comes to transferring it between CRO and Sponsor, or Sponsor to Sponsor, you just give them a box of the stuff and walk away. Also, something I have heard, although not the best approach, let’s be clear, is there is no audit trail with paper, no late metrics, so if the document was filed yesterday, but technically one year late… no one has to know. (You might want to check out Article 57 of the EU Regulation 536/2014 which gives you some guidance.)

I think over all though you can tell that paper is difficult to manage, it’s a nightmare to audit, and it opens itself up to inefficiencies at every turn. Which is why the industry started to move away from paper, taking the TMF and making it efficient, effective, exquisite, edgy… an “e” TMF if you will.

eTMF: Rated E for Everyone

So, the first thing to know, nowadays people will use TMF and eTMF interchangeably, every study needs a TMF, it just so happens that a lot of these are now stored in an eTMF format. But they will also refer to the eTMF as the system which holds all of their studies. I know it’s confusing, but just keep that in mind when you are speaking with people and think about the context. Talking about general processes in the eTMF, it is likely they are referring to the system. Talking about filing documents to it, they probably mean the study.

The next thing to know is why the eTMF is so, so much more than just storing documents. With the move to electronic storage came new challenges, electronic meant computerized systems, which meant validation, which is basically a way of providing proof that processes worked consistently, and that data was safe and secure at all times. It also did not take long to identify that storing the documents in an electronic “folder” was inefficient and not taking advantage of the real opportunity.

For this reason, metadata was used, we have touched on it before, but metadata is the data about the data, or in this case document. Best example is to think about searching Spotify (other streaming providers are available). You search for Punk Pop as the genre, or maybe Taylor Swift as the Artist, how about music from the 80s. All of these are metadata, the data behind the songs that help to categorize it, organize it, and help you discover it. Suddenly documents were not just a document stored in a folder but filed at a certain level, assigned the Zone, Section and Artifact they were attributed with, the date of upload was captured, and the date of the document finalization was entered. The power available to the teams was like nothing they had seen before, it went from Prince Adam to He-Man. They could suddenly search and discover data across large groups of criteria. “Show me all of the Monitoring Visit Reports for Germany?” DONE, “Show me all documents submitted to the TMF during the month of September?” DONE.

Also, remember that thing we said earlier about global trials and global teams, well now the TMF is electronic, it isn’t confined to a shelf in the office, it is online, it is accessible from anywhere, anytime. What about the concerns over damage or loss of paper? Now you have digital data that can be backed up and stored in separate locations around the world making sure you have ultimate data redundancy.

Something else that was never possible before was the ability to run reports, get true insight into your data. Having all this data recorded during submission or captured while performing quality checks on the documents suddenly gave you information in the form of metrics and reports. Teams could see where most of their data was coming from, when they had busy periods, or where problems had occurred from late submissions or lower than desired quality. This led them to having knowledge, what were the areas to focus on for improvement, where had they seen success in the past and how to replicate it. It is this reason you will hear a lot of people talk about the data driven TMF, documents are no longer the only thing to focus on.

Over the last 10 years there has been an accelerated drive to achieve a TMF that has data filed in a timely manner, that meets a high level of quality and is as up to date and complete as possible, and if those three things sound familiar, we will be touching on the TMF Trinity in the next blog, spoiler!

The First Step in Proactive Management

The title of this blog states that the eTMF is more than just a Document Management System (DMS) and it’s in this section I want to explain why.

A Document Management System is designed to receive, track, manage and store content, some are often used to create the content as well to keep it all within one system. They are great at all these things, but they also have a limitation in their design, they can only manage what they know about, there is no concept of things that will come next. If we use an SOP as an example, they manage that single SOP, they don’t have a way of keeping a space open for the next version that will appear in the future, or understand that with a new SOP will come a new work instruction or set of forms. You upload or create documents when you need them as you need them, you don’t plan for what you will need in a couple of years from now.

We spoke in the last blog about the Reference Model and the Essential Documents list, with the advancement to the eTMF it is no longer just about management of what you have but what you need. Placeholders are used in eTMF systems to indicate required content even if it is not needed at this stage in the trial. There are also triggers that will create more Placeholders as your trial progresses, raise that Protocol Amendment and an eTMF can tell you in seconds that you will need documents at specific Countries and Sites across all the impacted Artifacts and will create these placeholders so you can track progress. A DMS will never do that because it is not what it is designed to do, it is probably one of the strongest features of an eTMF and in my opinion is one of the things that really move the needle from Reactive TMF Management to Proactive TMF Management.

The TLDR section, previously known as Summary

Hopefully this was a good read and has given you some insight and understanding of where we came from with TMF management to where we are now. Paper is still around but the shift, especially after the last few years, is sprinting towards electronic ways of managing the TMF. Paper will always have a place in people’s hearts, especially those who remember simpler times, but I think everyone would agree that the complexities brought on from the move are far outweighed by the ease, accessibility, and insight you gain from your TMF.

As always, thank you for reading this blog, it was a long one I know, but then again aren’t all great third instalments? Indiana Jones and the Last Crusade broke the two-hour mark.

In the next blog we will address our final topic “Health; Mind, Body, Spirit and TMF”. Fingers crossed it isn’t anything like the fourth Indiana Jones, I promise there won’t be any aliens at least.

Have questions about Clinical Trials and the TMF? Watch our "Clinical Trials and TMF 101 Learning Series" webinar here.  Or, contact me today if you would like to talk more about anything Clinical Trial and TMF related. 

Until Next Time

Rob Jones

Read the previous blogs in this Clinical Trials and the TMF 101 series:
Blog 1: Basics of a Clinical Trial
Blog 2: What is this TMF you speak of?