Do you have a plan for receiving your TMF from your CRO soon? Have you mapped out your strategy and how you will ensure you are maintaining the chain of custody for what is one of your most valuable assets? The TMF is the story of your clinical study and needs to be handled appropriately.
Key areas covered:
- Planning for the handover of the study TMF
- Key considerations when migrating or transferring a study
- What all should be included in the export for compliance
- Regulations to support Data Integrity
Watch the full session, or read the full transcript below. For more support regarding an end-of-study transfer or long-term TMF storage, contact us for a demo at any time.
Full Session Transcript
Toban Zolman: Welcome, everybody, to today's webinar. My name is Toban Zolman and I'm joined here with Marion Mays. Today we're going to be focused on the process of collaborating with your CRO for end of study transfer and compliance.
This has been a very popular topic for us at Kivo. I think it affects a lot of organizations, and so folks are interested in trying to figure out how to solve that. We're going to focus on five key areas today. Marion is going to go through working effectively together with your CRO, looking at that from a document management perspective, as well as the oversight and quality aspects to these transfers. I'll talk through some of the actual logistics and technology behind successfully doing end of study transfers, and then we'll wrap all of this up with some keys to success based on our experience helping customers through this process.
Just to do some quick introductions, I can start with Marion. Marion is our Senior Vice President of Clinical here at Kivo. Marion has a wealth of experience working for sponsors for CROs, for software vendors, and has directly helped manage inspections and end of study transfer for probably more studies than she would care to admit. She's got a wealth of kind of practical, real world experience on this process.
My name is Toban Zolman. I'm CEO at Kivo and have worked extensively with large scale pharmaceutical companies developing business process, especially on the regulatory side, and adapting new technology to support global business process. So between the two of us, I think we'll be able to address a lot of the practical implications to how to pull all of this off successfully.
With that, I'll turn it over to Marion and we'll kick things off.
Marion Mays: Well, thank you, Toban. I appreciate it and looking forward to sharing with everybody today. The first thing I'd like to do is to ask a poll.
I'm going to launch the poll, and if we can talk about where you are, are you using your CRO, and do you have a plan for what are you going to do when your study is ready to come back to you, or what are you doing today about it? Thank you for your feedback. This helps drive my conversation, so I appreciate it.
Okay, so it looks like we have some that leave [the TMF] with the CROs, some that haven't figured out the right place yet, and it looks like people are still trying to decide on some of their processes. I'm going to go ahead and share those results with everyone. Really, it looks like some of our participants today haven't quite figured out what the right place is. So I'm hoping that after today, you have an idea as to where you want to place your eTMF for inspection purposes and potentially long term storage.
I'll quickly get started here. Thank you, everybody, for sharing your insights.
So, collaborating with your CRO.This is probably one of the most important things that you need to do to be successful with your eTMF and inspection, really. Think of your CRO as your partner. They are running the study for you and collecting all of this essential information, and it's going to come back to you at some point in time. So let's make sure that it's what you need, and what the different pieces are that you're going to need later on after your CRO is no longer with you.
Let's talk a little bit about what that really means overall. Does moving [the TMF] from one place to another, does it have an impact? How do I do that?
Let's start with a scenario. Your study is closed. It's sitting with your CRO. Looks like the study went really well. You've got some really good data and everything's going smoothly. Now you need to start thinking about what you're going to do, right? Typically, we outsource as sponsors more than just the eTMF piece, but all of the other documentation that goes along with your study. So let's not forget about all those other pieces that are truly the evidence of how the study was conducted, which means that you're going to need that for approval. It may be required in inspection , so we need to put it in a place where it can be inspected. Sometimes it will be inspected right away, and other times maybe it's your Phase Two, or it won't be inspected until after your Phase Three is completed.
Let's think about what that is going to look like. Now what? What do I do? Which path do I take? I'm going to get all this information back from my CRO. The study is over. Now I'm actually going to lose access to those individuals who've been working on my study. How does that handover look ? Do you have all the information and have you figured out where all this documentation is going to go? You may have an eTMF already, but where are you putting all the other documents? What about the EDC information? What about your safety documents? Are you going to take that on? Where are you going to put all of this?
These are all really important things, and I love this slide because oh my gosh, how many of us have gotten our eTMF back or our study documentation back on a thumb drive? What do we do with it? And does anybody know what's actually on this? So, as part of your end of study activities and your planning for the end of study activities, it's really important to think about how you're going to get your study back.
Is it going to be electronic, which is great, or I've actually had some people print out everything so they have a paper component just in case something happens. That might be a little over the top from my perspective, but really, we need to think about what's happening with this documentation and how you're going to manage it once you get it. If you do have it on that thumb drive or on a CD, is it encrypted? Do you have the encryption key? Those are all really critical pieces.
So what do we need to do? We really need to define that process. Define where the documents will be moved, what system they're moving into for not just the eTMF component, but maybe you want to put all of your pieces into your eTMF and have one consolidated inspectable document management solution.
Define your workflows. How has everything been submitted? What about those documents that seem to show up last minute? What are you going to do about those? What if you find that some of the documents that you have aren't exactly what you expected and you need to have new versions or a copy of something from the site? Maybe the last log that you have of signatures is not the most current one, but maybe one that was collected a long time ago and you need to have the new one. You need to define that completeness expectation. You need to decide what is complete. When are you going to say that you have everything that you need? Have you standardized all that content and where is it being stored so that you can access it for your inspection and for later use as well?
Let's talk about an approach and consensus. These are important things. Does your TMF plan define what that QC activity is? The end of study...maybe you talked about all the things that are going to happen along the way, but did you talk about the end of study transfer and what checks are going to be done? What are you going to do if you don't have what you need. What is your escalation pathway for that? Did your functions understand their responsibilities? Was that clearly outlined to them? Did they have a process? If not, what are you doing to compensate for that at the end of study?
Then your timeline expectations. Not just for getting stuff from your CRO, but also for your team. How are they going to make sure that they have everything that they need and make sure that the documentation is there? One of my suggestions always is a milestone base when you're doing your QC checks along the way, but then also at the point in time of that lifecycle, this critical step is your study is closing. Do you have everything that you need so that TMF reporting becomes a critical piece as part of your deliverable? That index that comes along with the export...does it have everything that you need?
Oversight - it shows that you've done your activities, did you have any findings, and is your CRO responding to your findings. So those close out activities and the support that you're expecting from your CRO, is that clearly defined in your TMF plan so that everybody knows what that expectation is and what needs to happen as we get closer to the end of the study?
I want to share my next slide. It comes from the MHRA. These pieces are really about what happens, and is your TMF lifecycle really compliant. What a lot of [the inspectors] see is that there's a gap. Your CRO is managing your TMF, and then you have to actually provide the archive solution for it, but you may also have to provide that inspection solution for it. What are you doing in the meantime? How are you managing that activity and making sure that it's inspectable and accessible for that inspection? This is where the inspectors actually see a big gap, because what happens is that they see that the sponsors are putting it on SharePoint or a non-validated system, and therefore those audit trails begin to be lost in the mix of who's looking at what and who may be changing something along the way. This is an important thing to consider.
With that, I do have another poll. When are you thinking about you're going to receive [the TMF] back? Is it right when [the study] closes? Is it a couple of months from now? Maybe it's six months, or maybe your study isn't closing anytime soon, therefore you're not expecting to receive anything back.
What I'm seeing right now is within the next three months. It's pretty even between the next three months and the next six months...and some people within the next year, looks like some people aren't going to get their study back for quite some time.
All right, thank you, everybody for participating and hopefully now you can see the results of the poll. As I said, looks like quite a few people are getting it back within the next three months, some in the next six months, but a significant amount are coming in the next year or so. So hopefully these tips will give you some opportunity to put some things in place in order to make sure that you have a successful end of study transfer.
Let's talk a little bit more about the end of study transfer. All the things I've been talking about are really just reminders to begin your trial journey with the end in mind. So what is the objective of your trial? I think most goals are a successful trial with the evidence that you need in order to display your inspectorates, that you have a compliant and ready therapy or drug or vaccine to share with the world that was done in a compliant manner.
So setting things up at the beginning makes things so much easier, and also keeping track of what's happening. Do you know where all your data is? Have you clearly set out in your TMF plan where all the data should be kept, where it is today, where it's moving to, and where the inspector is going to be able to actually access it once the study has closed? Those are all really important things. Also, are you consolidating it? As I said before, are you going to try and create a single structure with all the information? Is that even possible? A lot of the inspectorates have shared with me that they don't want to go through 16 different systems to try and figure out what happened in a study. So trying to consolidate is probably something that you should really consider. They would like to see three, maybe four systems that they would have to access as they understand that. Sometimes it is difficult for certain data to be put into another system, but something to consider.
What is your long term strategy? This may not be your only study. Hopefully you're going through the different phases and you've reached your phase one, (which is your safety) moving into your phase two, which is beyond your healthy volunteers and really trying to incorporate a larger, wider, diverse group of individuals to participate in this trial, and then potentially your phase three, as you might be looking to expand into a larger market. But really, what is the long term strategy with how you're going to manage your data and keep it compliant for the number of years? You may be thinking that short term where you just need to get through this one trial. But really the consideration about how are you going to manage this long term is, most of the regulatory requirements are around 25 years. Canada has moved it back to only 15, but most require 25 to 30, sometimes a little bit longer than that. So how are you going to maintain that? And don't forget about the site files, even though you as a sponsor may not be directly responsible for the archiving of that. How are they also managing their information? Because they also need to keep it for the same length of time that a sponsor does.
Is your CRO supporting you through this process? Are they going to hold your trial with all of it? And you as a sponsor may still have that component of your oversight activities, your contracts and your other vendor information, so you're going to have to be able to grant access to the inspector of that information as well. Even if your CRO has your main TMF in an inspection-ready state, you as a sponsor still have documentation you will have to show. How are you going to grant access to that? Have you clearly articulated how you're going to do this transfer, as the regulations also require that it be maintained in a certain state, that the data integrity must remain intact. How are you meeting this requirement? Very important to have a migration plan.
Your end of study transfer...what do you need?You need your eTMF with all of its metadata and all of its bits and pieces, all of the versions, but also the audit trails. This shows your evidence of what happened with that document throughout the time that it was sitting with your CRO. What's happened with the TMF and the TMF documentation? Also your safety content, don't forget that. That also needs to be transferred over to you from your CRO. Your data management...what's happening with your CRFs and DCFS? Maybe you used ePRO or something like that. So the database along with that. What about the stats and medical writing? Those are all critical pieces, especially your CSR at the end of the study. Any regulatory too, so if you chose to outsource your regulatory, you also need to make sure that you're getting all of those components. A subsection of that will be in your eTMF, but a lot of it doesn't always make it into it, especially around correspondence. So really important pieces to think about how all of this is going to be transferred.
Moving through inspection readiness. Is it after or before? If it's after, how are you granting access? Are you comfortable with what's going on? Can you give them controlled access? If you're putting it on a SharePoint rather than in a controlled, validated system, how are you granting that access and how do you know what's happening with that information? Can you give them read-only access? What kind of navigation are they able to use in order to find what they're looking for? What's the searchability of the information?
Migration steps, of course. They may ask you, how are you controlling this information? How was it moved? What steps were taken? Do you have that documented in a migration or data transfer plan? Or do you have an SOP that you use that already articulates exactly what happens when you receive documentation back from your CRO, how you receive it, and what's the process? What are the steps that were taken to ensure the integrity?
Then, of course, we have the inspectors....Where are the documents in other systems of record? Do you have a roadmap for them? Can you also grant them access to that full audit trail? Especially if you're using a non-validated system, where are all these bits and pieces of how this all happened and how were the files controlled? That's probably one of the questions that I get asked all the time, is how can you ensure that the information is accurate and complete?
Moving through...what is your contract with the CRO? Maybe that is ending. One of the scenarios that I see quite often is that they contracted with the CRO. The CRO even helped them through the inspection. Now they need to figure out what to do with their documents because the contract with the CRO is coming to an end. So now you need to move your TMFs regardless. So do you have an eTMF system? Is that what you're moving it into? Maybe you're managing and documenting the handover and you're moving it potentially into an archival system. What steps are you taking to ensure you have all your data? What checks are you doing? Are you recreating some of those checks that you did at the end of study? What are the control mechanisms that you've put in place to make sure that the long term storage activity actually meets the regulations? Making sure, how often are you checking that data and going back into your archival system to make sure that the documentation is still there, accessible, and any updates that might have been done to that system haven't affected your content? And yes, some studies are old, but they still may be inspected. I've had studies that have been inspected that were ten years old. Of course, then they are our paper, so we were pulling the paper back...hopefully nobody's in that situation.
As I'm moving through, this is talking around the long term considerations, right? Because the EU has a requirement of 25 years. Obviously, it's not necessarily the medical records themselves that are being held by your investigator sites, but really the entire master file. That means all of your safety, all your data management, all of that is all inclusive of that 25 years. So how are you managing and maintaining those electronic records? It states clearly that they should be maintained in a way that is accessible and that you can grant access to the authorities should they request any information.
Nowadays, most [inspectors] want to be able to access it themselves.The FDA used to go through a process where somebody could navigate for them. Some inspectors are still not quite comfortable with using an electronic system on their own and still require that. But as of January, they've been granted the ability to have access themselves and navigate on their own.
Then the transfer. [The inspectors] are going to want to know how it was documented, who was involved in it, what checks were done. So you need to be able to provide them documentation, how that was done. Because one of the new regulations from the EU clearly states that you need to have documentation around any changes or alterations to ensure that the tree of the information is intact. Really a critical thing to make sure that this is all clearly documented and that it's evidence-based, so that long term solution is really important.
So that controlled transfer and making sure that it's imported appropriately...make sure that you have limited access, because you still need an archivist that is managing and maintaining those documents making sure that they are accessible, and that they are maintaining in a state of integrity. That controlled, read-only status of all the content; it continues to have an audit trail so that they can clearly see who has looked at this documentation. Were they appropriate to be having access to it, making sure you have those periodic corruption check...That's an important thing. Nowadays with electronic systems, there are lots of updates, changes, and modifications that happen. Is it altering the access or the documentation in any way?Then the archival formats, which a lot of people are becoming more and more familiar with.
With that, I would like to have one more poll. I want to know, do you have end of study plans? Do you think now that you've heard everything that I talked about, will you be working on one, or you don't know what to do? I'll give everybody a chance to respond.
What I can see is that some people will be working on it. So if nothing else, we made an impact today. People are now looking to consider how they're going to do this, which is great.With that, I'll stop sharing the poll.
What I would like to do now is turn it over to Toban, who is our software expert, who will walk you through some of the steps that you should go through when you're transferring. Toban?
Toban Zolman: Thanks, Marion. I appreciate that. So my goal with these next few slides is to really dig into what to expect as you go through this process and how it's going to work. Literally what the mechanics are. And this is not just specific to our software, necessarily. Finally, to be able to help you identify some critical considerations that you should be looking at when you select a software vendor and start to build a process to do the sort of transfer that Marion talked about in a controlled way.
What I've outlined here on this first slide ( just as quick overview) is the basic process that we talk about with our customers when we go through a TMF migration or a transfer from the CRO system to the sponsor system. We'll identify a process for a controlled transfer. We'll actually run that import to take the TMF from whatever it's in - could be on a file share, it could be in another system - and do QC of that import to ensure that everything came through correctly. Now you're going to manage that TMF once you take possession of it, take that TMF through an inspection and ultimately meet long term storage and archival standards and ensure that you're maintaining that in a compliant way - one that can stand the test of time. In other words, that the media or however you're storing it can actually stand up to 25 years of archival.
Let me start by talking through the controlled transfer. The key piece to this is maintaining a chain of custody and access at all times and being able to demonstrate that. I'll tell a bit of a story here and then talk through how we handle this, specifically with Kivo. The process that happens a lot is that once the CRO's contract is over, they'll literally dump the TMF onto some sort of media - it could literally be a thumb drive with their logo on it, the sort of thing you would get for free at a trade show - and that is literally the entire evidence of your study. Once the CRO hands that off to you, they can walk away. They've completed their contractual obligation.
The problem is, if you're literally receiving that on something like a thumb drive or DVDs or whatever it is, you've broken that chain of custody. By the time you import that into a system, weeks, months, years later, you don't have evidence of what happened to that data in the interim. So one of the things that we've built to control all of this is a specific process from a secure FTP site where the CRO can upload into that has controlled access. The only capability is basically to write to that location by the CRO. The Kivo platform can directly access that and ingest the data directly into the system. Once it's ingested in, everything is captured via audit trail. That really ensures that that chain of custody is tight and it's quick, so that there is not a period of weeks or months where you have to justify during an inspection what happened to the data. Nor do you have to build an incredibly elaborate process of maintaining control and chain of custody in that interim piece. This is one place at least where technology actually simplifies process and tightens up what you need to do from a compliance and access standpoint to ensure that everything is maintained.
The next step of this is really important. Your CRO is most likely using some software platform to manage the TMF data. That platform is going to be controlled, we can assume, meaning those documents have audit trails, they have metadata associated to them, they have naming conventions, versions, approvals...all the stuff that you would expect from a compliant document management system of some sort. The way that we handle this (and this is less about, "hey, this is what Kivo does", and more about these are the things that you need to understand so that you can critically understand what process needs to be built). When you go to take on a study at the end of the trial, there's effectively three things that we look at through this import process.
The first is document metadata. You want to be able to take all of the metadata from the CRO system and preserve that and preserve that in whatever system you are importing into.
Every TMF vendor on the planet, it seems, has their own paradigm for how this metadata is structured, what metadata they track. Then on top of that, there is system-specific metadata related to actions performed in their platform. So if documents were approved, if documents were converted to PDF, all of that kind of additional context ends up in metadata in some form. One of the things that Kivo does is when we built our eTMF platform and our import utility, we basically created a highly flexible metadata infrastructure so that we can take it all, even if it is rendition information or job information from other TMF systems. We can stash that in Kivo, it's queryable, it's available to an auditor if it's relevant. Preserving that kind of rich metadata history from system to system is super critical.
The second piece to this is audit trails. From a compliance standpoint, this is highly important. The way most systems export a TMF, those audit trails get dumped into essentially a CSV file. You have a few options on how you would handle this. One would be to import those files in flat, so when it comes into your TMF system, you have the entire structure of all of the documents in the TMF, and then you have an additional file that represents the audit trail from the legacy system. What we've done at Kivo to really make those audit trails be more friendly for virtual inspections is we actually ingest the audit trail and layer that into ours. So for any document in a Kivo TMF, you would be able to see all of the actions that happened in Kivo and then all of the actions that happened in the legacy system prior to import. This gives an inspector the ability to generate reports that show actions taken by users, taken in various systems and really understand kind of the nature of the study and who did what when.
Then the final piece is maintaining source and renditions. If you are ingesting a TMF, and it came from a more full-featured document management system where the CRO was authoring documents in Word, rendering those to PDF, supplying those documents to investigator sites, then you really want to be able to capture all of that documentation. One of the challenges of storing a TMF in a system like Box or other kind of file share based platforms is even if you control access, you don't really have any real connective tissue between the audit trail file, the source file, and the rendition file, especially if there are multiple versions. You have to visually do that as you navigate the folder structure in a file share. If you're using a proper eTMF platform, then the system can stitch all of that together so that you have a single view of a document and can see multiple versions of it, see the source, see the rendition, and all of that can be handled appropriately. Layered onto this are requirements for the CTIS portal in Europe, where some of this material that needs to be submitted through that clinical trial portal needs to be redacted.
We're seeing a lot of our customers rapidly move into a phase where for a single document, they have multiple versions, they have source, they have the PDF, and they have the redacted PDF. Stitching all of that together - either through process or technology - is a critical piece to making sure all of that can be maintained and made sense of over time.
Marion, if you advance, I'll talk through the QC portion of this. Technology is awesome, but to have a compliant process and actually understand that everything happened correctly, we always insert humans into the mix to do a proper QC. The way that we handle that is with an automated layer and a manual verification layer. On the automated side, what we do and feel like is a best practice is to look at the data source where we got the files. In our case, it's that secure FTP site if you're using a different system that may be a file share or an FTP site that the CRO has granted you access to.
What we advocate is running reports that verify document counts and checksums for everything in the TMF so that you have a picture before it goes into your system of exactly what files are there, how many there are. How many folders there are, if it follows the TMF reference model, if you have metadata, how that metadata is stored, what those values are, and effectively use technology to generate a pre-list of all of the documents and all of their attributes. Do the import and then run that against the database of the system you're importing into and ensure that everything matches. If there are discrepancies, there's a reason why there would be a difference there. A particular metadata field was excluded for an intentional reason, or a document was known to be in a corrupted state or something to that effect. Having that automated pre- and post-import as part of your QC process is really important.
The second piece is a manual verification. That's taking a percentage of your documents and manually verifying content and the results of the migration. So that's literally opening them up, ensuring that the document can be viewed and browsed, ensuring that the metadata lines up, ensuring if there's both source and PDF that those work as you would expect. Setting a percentage of QC that you would do and running through that on every study that you take possession of is a critical piece. Because, again, if you make a mistake or have a technical problem at this stage and that isn't discovered until an inspection happens five years later, the chances of the media that you received that on -whether that's a thumb drive or an FTP site - either still holding the data or not being corrupted, is relatively low. You want to make sure that you get this in a system and that everything is correct and compliant before time passes. That's how we look at QC, which leads us into the management stage.
There are a few pieces to think about when it comes to the management of the TMF. This is much more of a living process, especially if you're taking possession of your TMF and then managing it through the inspection process. Really what you're managing at that stage is both content and access. You want to be able to manage missing content. Your CRO may be done with the study, the contract may be over, but that doesn't mean that there won't continue to be safety information revisions or just missing documents that continue to trickle in from investigator sites. So you need a way to add that, layer that into your system and do that in a way where it's controlled. When you reflect back on that during a virtual inspection, it [needs to be] clear when those documents came in, how they were processed, et cetera.
The second piece to [TMF management] is making it easy to find and view any documentation in the eTMF and be able to search across metadata fields that the CRO may have added in, because those metadata fields could be rich with context related to their process, their system, et cetera. Searching capabilities are really important. The way that we handle that in Kivo (and you can kind of see this in the screenshot) is we follow the TMF reference model. We build out a visual representation of that entire hierarchy so that you can navigate through that and then have the ability to search across file names, metadata, et cetera, to get to information that provides contextual information for whatever is being looked for.
The final piece is being able to distribute documents and data throughout your organization or to other sponsors, if you have partners, things of that sort. Where we've seen this fall down before is if you receive the TMF from your CRO, you stash that in a controlled file share and then you build, let's say, a marketing partnership with another sponsor and you need to give them access...All of a sudden to do that, you reopen access to the TMF. If it doesn't set those permissions right, now all of a sudden you have another party that has read/write permission to that location and it becomes problematic. Controlling access in permissions so that a few key employees have the ability to manage trailing data coming from investigator sites and also the ability to give access to partners without them having the ability to write...All of that is an important piece to the puzzle in setting up how that is going to be maintained over time.
So beyond this, you also want to be able to give inspectors controlled access to the eTMF. This is an area where I feel like Kivo has an advantage being a post-pandemic product because we were able to design our solution with virtual inspections at the forefront of our process, of our permission structure and the general feature set as well. What we've done is given our customers the ability to a invite an inspector to the platform and have that set up in half a dozen clicks when an inspector would log into Kivo. This is an important consideration if you're using a different system. You want to be able to curate their view without hiding so much information from them that they want to peek behind the curtain and see exactly what else has happened. The way that we've handled this is we hide draft documents. For example, if you have a protocol that the inspector needs to see, they can see each version that was approved when it was approved, so there's context, the effective date of that version, but they can't see all of the draft documents that you and your colleagues went back and forth on to get to those points.
We hide draft documents, we identify effective dates, and we also identify if there are documents that are not in the eTMF for specific reasons because they're being housed in other systems of record. Marion spoke to this in the early part of her presentation, that inspectors prefer to have a relatively few number of systems, let's say three or four at the most. What this approach lets you do is tee up that narrative for the inspector so that they can very explicitly see which documents are in which systems of record. All of that is laid out in the eTMF to drive that narrative so they're not hunting and pecking and not sure where anything is at. Controlling that narrative to the inspector but making that feel like a seamless process is a critical piece in making those virtual inspections successful.
The final piece of this is archival long term storage. The important things to pay attention to here are A) controlled access - that's obviously a theme in everything we're talking about - B) that it's read-only so that once the study is closed and you have closed or archived the eTMF, that it is read only, that there is an audit trail in place. The final piece to this is periodic corruption checks. The way that we handle this at Kivo is if a study in our system is marked that it's in an archival state, we effectively cycle through those documents once per quarter and verify that the file that's stored in our infrastructure is not corrupted, maintains the same checksum, et cetera. If it doesn't, for some reason - the media that it's stored on, let's say, had some sort of hardware failure - that gives us an opportunity to go back to backups, restore that, move it to new hardware, et cetera.
You want to really ensure that you have your TMF stored on redundant hardware to really last long term. The shelf life of a DVD is typically a decade, which isn't going to cut it for long term storage. If you're using thumb drives or SSDs, those also have shorter shelf lives. Obviously, the more you spend, the better that gets. But really understanding the underlying hardware and what the redundancy backup options and expected life of that hardware is all critically important, especially if you are going to manage that yourself or turn that over to your IT group to handle those decisions.
You want to make sure that you can open a document in 25 years. If you saved that in Microsoft Works 95 format, that could be problematic. PDF is obviously the lingua franca of those archive standards, but there are certain documents that that isn't practical for. You want to pay attention to where you have files that fall out of ISO standards for Archival and make sure that you've got software that can manage that, that you periodically review that and kind of make all of that happen in an effective way.
Quick question that came in. "Please confirm that you will hold our study for an indefinite time once the CRO is ready to transfer. We don't have a system of our own." Yes, that's totally what we are here for. We have a subset of features and a product line that is built and priced specifically to hold those for indefinite periods of time. Absolutely.
I'll wrap this up here with some tips. This is where process and technology meet. We talk about defining clear roles and responsibilities with your CRO. The number of meetings that we are on as a vendor where the sponsor and the CRO are completely misaligned on who's doing what, and they've been working together for three years on this study and now it's coming to the end and no one ever thought about a lot of these considerations...That's important. Defining those clear roles and responsibilities helps.
Ensuring you have an outline. You have outlined how the TMF will be transferred and doing that prior to transfer is critical. We have a large number of customers that when we get involved, they already have the TMF. They got it months ago. It's been in an uncontrolled setting and now we're helping them back out of a complicated situation where they can't show chain of custody setting. Clear deliverables makes it easier to talk about these things.
I would say prepare to have difficult conversations with your CRO about timelines, about quality, about response to queries. It is a very consistent theme that we see where both the CRO and the sponsor are shockingly ill prepared at the end of the study to deal with the mechanics of how this is going to be handed off.
The final piece to this is pretty straightforward but ensure you have a validated and compliant system for storing your study content. You're opening yourself up to risk for inspections if you don't have this in place, if you can't show validation and you can't show compliance.That's a critical piece to all of this. It doesn't have to be a company-altering-sized project. It's possible to do this, especially with solutions like ours that are cloud-based and where we manage validation on behalf of our customers to get through this relatively quickly. It just has to be done. You have to go through those steps to mitigate risk.
I will turn it back to you. Marion, I know you have a final slide to talk through other lessons learned and keys to success from your side.
Marion Mays: Thanks! That was great, wonderful information . Just a few last words of wisdom.
Some keys to success that I have found in my journey is 1) make sure that you think about all of these things at the beginning and not at the end. Start defining your deliverables in your contract. If I can say anything else, make sure the TMF, quality of the TMF, all of that is in your contract with your CRO. Establish that TMF plan that talks about how things are going to happen, but also don't forget about the part that talks about the end of the study and what happens then. Establish those metrics and use your system. There is so much that the system can do for you, whether it's the CRO system or the one that you have in-house. I think it's important, the reporting, because it shows what's happening with your data.
My last bit of success is really if you don't understand something, reach out to your vendor, reach out to your CRO and work with them collaboratively. Don't just assume because that's one of the things that Toban and I have found quite recently is that, "oh, I thought you were doing that." "No, I thought you were doing that," and back and forth. Assumptions are not good. Make sure that things are well spelled out and make sure that everyone understands what their role and responsibility is.
My last thought for today, is remember what the TMF is. If you get nothing else out of this, is remember that the TMF is your evidence of the trial. It is the most important asset that you have about your trial. It's going to be something that's going to stay with you for a long time and it's going to continue to come back and haunt you if you don't do it right.
Thank you everybody. Just as a reminder, this is recorded and we'll share that with all of the attendees. So thank you, everyone, for your time. We appreciate it. Have a great day and thank you for attending the webinar.
Toban Zolman: Feel free to reach out to Marion or I if you do have questions. Thanks a lot, everyone.
