Today's clinical trials are partnerships, between Sponsors, CROs, and other vendors. These collaborations enable small organizations to do more, but it also presents challenges. In this webinar, we discuss how to collaborate with your CRO early to ensure your trial master file is handled appropriately. After all, the TMF is the evidence of your entire trial. It is essential for inspections and any future sales that this data be handled correctly.
Key areas covered:
- Defining an operating model with your CRO
- Leveraging reporting to manage TMF completeness along the way
- Working with your CRO during inspection
- How to leverage eTMF and DMS technology effectively
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, "Collaborating with your CRO for Study Compliance." This is part of a series of webinars and white papers that we're doing focused around managing clinical trials. You're joined today by myself, I'm Toban Zolman, and Marion Mays.
We've got a handful of things we want to talk through, starting with how to work effectively together with your CRO, specifically from the perspective of document management. We're going to focus on oversight and quality and then talk through both the technology and the mechanics of end of study transfers, and then wrap all of this up with some keys to success.
To spend a couple of minutes talking about who we are and who you're going to spend the next hour with - Marion Mays is Senior Vice President of Clinical here at Kivo. She has spent years running clinical trials for sponsors, CROs and also working in software companies, and has a breadth of experience on this topic from really every perspective, the sponsor side, the CRO side, and the vendor side. My name is Toban Zolman. I'm CEO at Kivo, and we'll be talking through some of the technology implications of this process and how to make all of that come together in a compliant way.
Marion Mays: So without further ado, we're going to kick things off with a quick question. Do you believe you're working well with your CRO?
Okay, so here we go. Let's share these results with everybody. Hopefully, everyone can see them. It really looks, Toban, like people are experiencing some challenges, kind of to be expected. What we can do today is talk about some things that maybe will make things a little easier for everybody, and some approaches that I've used myself in the past to try and facilitate some of that effort.
It's all about collaboration, of course. I really believe that you need to think of your CRO as your partner, not just a vendor, because they are integral to making your trial healthy and keeping everything in order for you. Really agree on the evidence of the trial - how things are going to be done, where things are collected, evaluated, and generated. All of those pieces are all the different components of the trial.
How can a sponsor work with a CRO? I can't even say that today CROs work effectively. There are lots of different things that can be done, but I think setting some expectations at the very beginning...defining what the operating model is, and defining whose system is the primary one so there's no question as to where things need to be stored. People know who can grant access, who can have access, what type of access, etc.
Defining your workflows. How are things are going to be done, who's going to approve what, who's going to look at what, even how are we going to respond to questions! What is the expectation around when all this needs to be done? Those milestones and those events, defining all of those things that are going to be happening...some are unexpected, of course, but really defining what completion expectations are even. Because what I might think is complete, somebody else may not. Putting that line in the sand as to what that is. And of course standardization of content. We all know about good documentation practices, but really, what does that really mean? It also includes where things are stored so that they're stored in the most appropriate system.
Alignment of processes. The CRO have their processes, vendors have their processes, and of course, you as a sponsor would also have processes, or you might adopt one of the others. You need to come to agreement as to how this is all going to come together, because they have to marry up at some point in time. As the way to do that, you could define metrics and what is acceptable error rate. For me, maybe a 5% error rate is acceptable, but maybe for somebody else only a 2% error rate is acceptable. Or maybe 20% error rate is acceptable! Everyone has a different definition. Share that with each other as partners. Make sure that everyone knows what the expectations are.
A key focus for regulators is ensuring that the sponsor provides evidence of oversight. You've delegated a lot of authority to your CRO and potentially to your vendors. Make sure that you have evidence around that. Be sure you are able to provide information to the regulatory bodies of what you did. Should you find something that isn't correct, what efforts were done to correct it, but also that you checked on things and that, yes, you were comfortable with what was going on. If not, that you did something about -
Toban Zolman: Sorry to interrupt. We have a question related to operating model. Is the operating model what goes into the contract?
Marion Mays: Thanks for that. I really appreciate that question. That's actually a critical piece. That's where you need to describe how you're going to work together. Unfortunately, so many times when we're working with CROs, we forget about some of those things when we're writing up the contract. I've seen many times when people haven't even described what's going to happen with the TMF, who's going to manage it, or how it's going to be managed. Then at the end of the study, everyone's going, "well, I thought you were doing it, I thought you were doing it." Great question.
Now - what inspections look like and supported. Is your CRO going to be there to hold your hand during the inspection or not? Are they going to provide a quality person that might help you? That also should go into your contract. Are you going to need that type of support? Some consensus needs to happen.
There are key areas that you really need to put in place, primarily your TMF plan. If you don't do anything else for your TMF, this is what you need. You need to define your QC aspect: what, when, how and what are you going to do when things aren't there or they're wrong. Outline the function with clear responsibilities outlined. Who is doing what? Especially if you have multiple CROs or multiple vendors, it's important to define who's going to do what part of the process, what are their responsibilities, and what the timeline expectations are. As I said before, those SLAs are critical to hold people accountable. If they don't know they're supposed to be doing something by a certain time period, maybe something else happened and they didn't feel that it was as important as you might think it is. Setting that timetable is really important.
Milestone base is a good way of trying to keep track of what's going on. There's a lot of moving parts within a clinical trial. Setting those milestones is really important. There are a lot of references out there that you can leverage as well. Don't forget about the TMF reference model website, which is now part of CDISC. They have some milestone definitions there. They have a lot of helpful references.
Then there is TMF reporting. Make sure that you're getting regular output. If you're using your own [eTMF system], obviously you have wonderful access to the TMF. But if you don't - if your CRO is maintaining your study for you - it's important that you get those reports from [your CRO's] system on a continuous and regular basis so that you can see what's happening within your TMF and what critical documents may be missing. And that all comes down to your oversight.
How are you conducting [oversight] and documenting the findings when they're found? This is not just about the documentation. It's also about the activities. Especially if you've got a defined model, part of that model may be SOPs including activities that the clinical staff are going to be doing, or your monitoring staff is going to be doing. It's important that you have that oversight in how you're doing that. Whether it's checking those site visit reports or looking at the TMF, please don't forget about your close-out activities. Set those expectations around what should be in that and how that's going to happen.
With that, let's talk a little bit about TMF oversight and quality controls. Define your QC procedure. What are you going to check? When is it performed? Who performs it? Are you going to have your functional teams do that? Are you going to outsource that to a vendor? Are you going to be okay with just the CRO doing the work? You need to decide how that is all going to happen. Outlining all of that is critical.
Also agree on a sampling rate. Taking a risk-based approach is really acceptable within the regulated activities because there's so much documentation, it's not feasible to look at everything all the time. A risk-based approach is very acceptable.What's important though, is you need to decide what the sample rate and error rates are, and then agree how often should things be looked at. Should it be quarterly? Should it be every six months, maybe once a year? It could depend on the trial that you're running. Look at all those risk factors and agree how it's all going to be documented. Are you going to be okay with it just being documented in the audit trail (which is perfectly acceptable)? Or are you going to have them produce some type of document that shows what they checked, when they checked it, and who checked it, and anything that was found wrong. Again, establishing those metrics as to what that error rate and what is acceptable to you.
Let's talk a little bit about document management. Obviously, we are a vendor and we love our document management system! We leverage the system internally and you should [leverage your DMS] too. It's a powerful ally for you. It has an awful lot of information in it, and especially when you're working with your CRO, it gives you the opportunity to see behind the scenes. The power of that data can make a difference, so you can see what's going on. It can help you also define your quality approach, including those roles and responsibilities. You can see timeliness (or non-timeliness) of those activities, documenting your SOPs, your TMF plan and contracts, the expectations of the use of the system and how it's used, and review those metrics in real time...Sometimes we get those reports and we say, "yeah, we'll get to that later". It's important to start looking at some of that information early and see if you start seeing trends, because that could be an indication that something's not working right. Maybe your process isn't quite right, or maybe someone doesn't understand what that process is. Or there could just be a problem with your study. It is good to look at those reports in a timely fashion and do something about it, right? Talk to your CRO, talk to your vendors. If things don't look right, sometimes a conversation can really be helpful in understanding what is going on.
Then what you really want to be doing is driving continuous improvement. We always like to evaluate our processes and collaboration with our sponsors, CROs, and vendors. All of us must be working together. Making sure that we all are in sync and making sure that we are managing the trial appropriately. Then support your CROs and vendors with feedback! If they don't know that you're not happy about something, they can't fix it. They can't address it and they can't do anything about it. It's important to have that open communication and sharing.
Let's talk a little bit about oversight and leveraging the system. Remember, there's so much that a document management system can do for you, especially when it comes to oversight. You can look at the audit trails, you can look and see what documents are in there. It can gauge performance of your partners and your vendors and your CRO. If it's your system, you can see what's going on at all times. You can get reports from that system that allow you to check up on things. Systems can be powerful. Use them! Monitor the progress to identify potential areas of risk.
As I said before, once you start looking at that data, if something doesn't look right, look farther into that and have those discussions with your CROs or vendors to find out what's going on. Maybe there's a misunderstanding. We want to eliminate as much rework as possible. Everything that you have to do more than once costs the organization money and time, and could delay the trial. Rework should not be part of your normal process.
Check for completeness at your milestones. That's a good time to check and make sure that things are going well; that things are moving along the way that you expect them to. That feedback loop is really important. It is the way to share information and to fix some of those misunderstandings.
Ways to collect oversight evidence...I think this will be useful for a lot of you. The audit trail has full transparency. You can see who's looked at things, you can see who moved something, changed something, added something. Even the number of users in the system. Has my clinical project manager actually been in the system? Have they looked at that? Believe it or not, some inspectors actually take note of that and see who's actually accessed it and when. So something to keep in mind, how many times they access it.Your clinical project manager never even bothered to log into the system. Well, how did they make decisions on your trial?
With the audit trail there's evidence of documents flowing through the review process. If you have a defined process, you can look at the audit trail and it'll tell you whether the steps were taken that needed to be taken. Even though the system pushes things through the workflow in a controlled manner, this way you can make sure also that the right people are doing the work.
Next, approvals. Having that e-signature functionality really makes things easy to get approved in a system. And it gets appended to the document, so there's no question as to when it was signed, who signed it, and what their role and responsibility was during that time as well.
System reports and metrics. Great information. You want the ability to take and store that and show evidence to your regulatory bodies that you've done due diligence on your oversight activities. Don't forget about correspondence, even that email. I know we use email all the time to make decisions and to share information, but it's also great to show that you did follow up, that you actually pointed something out. Make sure that you're saving all those emails in your correspondence files within your eTMF system. If you're using the CRO's system as a sponsor, make sure that you are logging in on a regular basis and looking at those documents that are being stored in there. This shows oversight. This shows that you do due diligence and that you were involved in the trial. And then those meeting minutes...as pesky as they can be, they happen to be part of what we do for a clinical trial. This will also show good oversight.
I have another question for everybody. So hopefully we can do another poll here. If you're using the CRO's eTMF, do you know what you're doing at the end of the study? How are you transferring it? Where are you moving it to? So I see that people are participating now...we're all over the board, so let's share those results with everybody. Looks like everyone's kind of in between. They either have a validated archive system...Some people are just leaving it at the CRO...Hopefully you've thought about the risk with doing that. And some have not figured out the right place. So you're not alone. I just want to tell you that you're not alone. There's other people out there that are struggling. I'm going to stop sharing that and going to go back to my slides.
Let's talk about end of study transfer. It's really important that you think about this at the beginning. When we talked about the [CRO] contract, you must define how you're going to receive your study back, what components of the study are you going to receive back and how that is all going to happen.
Begin your trial journey with the end in mind. Where are you trying to get ultimately...obviously, we're supposed to have a successful evidence to demonstrate effectiveness of our therapy or drug, and that patient safety was top of mind. Those are some of the key elements that you need to be able to demonstrate at the end of the trial. Do you have everything to do that? Did you keep track of where all the data is? Remember that the TMF is more than just the eTMF. We have our safety system, we have our data management system. Don't forget about medical writing, regulatory, and those SOPs that were used. QMS is also part of all of this. We need to make sure that we have all the pieces together at the end of the trial so that we can effectively run our inspection with the regulatory bodies.
Are you going to consolidate the data into one single archive? Does that system support inspections or is it truly a full archive, which is I call it cold storage. What is your long term strategy to manage the data and keep it compliant? Because, remember, you have to keep it for at least 25 years if you're doing anything in Europe whatsoever. In Japan, it's about 30 years. In Canada, I believe it's only 15, but they're considering the 25-mark. In the US, we don't require you to keep it as long, but if you're going to go to market, you're still going to need your trial. Think about how long you need to keep this information for.
Is your CRO supporting you during your inspection? If the transfer happens after the inspection, that's fine too, but maybe you want to transfer it into your possession before the inspection so you have better control over what's going on. How are you documenting the transfer? Do you have an SOP? Have you created a transfer plan? How are you verifying that everything that's been transferred is moving and has been moved, and that you really do have all of your data? These are all things that you need to think about.
Again, let's think about what all the different components are. We have to consider how are you going to manage the following data sets. You need to think about, yes, you have your eTMF, and of course, if you're getting it from your CRO, what about the components that you had? Where are those currently stored? Are they in a validated system? If not, how are you going to merge them with what is coming back from the CRO? If you're doing that, shouldn't you have everything into the same system? Make it a little bit easier to run your inspection.
Let's talk a little bit about safety content. It's a bit more difficult to consolidate your safety content, but when you want to archive, you might want to archive your safety components into your archive as well so that you have a full understanding of everything that happened in your trial.
Then we have the data management, and don't forget about your ePRO and some of the other programs that are used to capture all of that data. All of that also needs to be considered - how that's being transferred and delivered to you, and where are you putting all of this. Don't forget about stats. All those SaaS data sets, your medical writing...and let's not forget about regulatory. Yes, a lot of us do our own regulatory, therefore we're not expecting much deliverable from the CRO on that. But a lot of it gets done by the CRO as well, especially if they might be the entity that's holding the information in specific countries. If you're doing multiple countries, you still need to get all of that at the end of the study. So this is all the sponsor's data, and you need to be able to put it in a location that is safe, sound, and inspectable at any point.
That was a mouthful. Back to archiving. It has been established that you have to keep it for 25 years. Of course, the medical records need to be maintained per each country's regulation records. It's stated the data shall be maintained in a way that makes them accessible to competent authorities. In other words, any regulatory body that requests it, you need to make it accessible to them upon request. So you need to think about how much time that might take, depending on the system that you're storing your documentation in. How long does that take to grant them access to that? If you're using a vendor to do that, what is the turnaround time? If you are leaving your trial at the CRO, what is their turnaround time to grant you access or the regulatory bodies access to that information? Sponsors must identify individuals. Even though it doesn't say any longer that you must have an official Archivist assigned, they still say that you need to assign responsible people to manage the records once the studies are closed and to maintain that TMF. That would normally be people like records managers, or maybe you have a CTA that this is ultimately their responsibility and make sure that they have the correct access and it's limited to only them.
Then the transfer of the TMF must be documented. So, like I said before, do you have an SOP? Do you have a plan? Are the well documented steps correlated with the activities that happen? Any changes or alterations to the TMF must be traceable. So anything that happens during that transfer or any transfer, even if you're doing a divestment or merger or acquisition, you're selling your compound, you still need to have this all well documented, and it must all be traceable. Who touched it, who did this, who did that, and how was it manipulated.
So I'm moving right along today. Toban, we have one more poll. We have the end of study plan. Have you put in place an end of study plan? Yes, no, working on one, or hadn't even thought about it.
Kind of what we thought it might be. Only a couple people have actually thought about it and have one. Sharing these results, you will be able to see that some people haven't thought about it yet, and hopefully we've given them some tools now to start working on it.
With that, I'd like to turn it over to Toban, who has put together some nice little slides to talk through about a control process when doing a transfer. Toban?
Toban Zolman: Sounds good. So I'm going to talk through where process meets technology on this and effectively how you manage this handoff from a CRO back into a system that you can manage and control. We will talk about this through six phases: a controlled transfer back into your possession, a import into a validated system, how you conduct QA on that, how you'll manage that content over time, facilitate an inspection in that system, and then ultimately archive the TMF per guidelines, 25 years or whatever is appropriate. So if you advance to the next slide, Marion, we'll start by talking about the controlled transfer process.
The key part of this is that Marion talked about, is you need to maintain chain of custody and access at all times. CROs that we have worked with effectively hand off the TMF on a thumb drive, which doesn't give you a mechanism to document chain of custody or have any sort of controlled access. One of the ways that we solve this is to provide a secure FTP site for transferring data directly from the CRO into our system so that there are not handoffs that have to be managed or any sort of alternate controlled access. From there, we can actually ingest that data directly into our system, which eliminates a lot of areas of risk, simplifies documentation in the SOP process, and generally makes that transfer happen in a highly controlled way. If you advance, Marion, to the next slide on import, I wanted to talk about what this process typically looks like.
The import flow is probably one of the more challenging areas where getting data from the CRO's TMF system into yours requires the most amount of planning. There are three things to talk about here.
The first is being able to map all document metadata. If the system was managed in the vendor system and they've captured meaningful information in metadata fields, it's critical to be able to map that into the sponsor system so that all of that information can be retained and available for an inspection. The way that we handle this is we can map to known metadata fields in our system either following the TMF reference model or by defining custom metadata fields. We also have the ability to preserve all unknown metadata values in our system. We've seen other vendor systems that have a host of different types of metadata. Some are traditional TMF reference model metadata and others may be related to actions or automation taken in the system. But we have a way to capture all of that and ensure that it's retained inside of Kivo.
The second piece to this is audit trails. Whatever system the CRO used in order to manage the TMF likely had audit trails produced. Those audit trails would capture every action that was taken. As you pull that back into your control, you need to be able to maintain those audit trails to identify anything that happened to the document. We even see cases - and are actively working on one right now - where the TMF that is being taken over went through multiple systems on the CRO side. So there are multiple audit trails that needed to be ingested into our system. One of the things that Kivo does to facilitate the inspection process is we don't just pull the audit trail in as a separate file, which is the traditional way of doing that, but instead we literally parse the audit trail from partner systems and inject that into our audit trail, identifying which actions were taken in the legacy system by the CRO and which actions were taken inside of Kivo. That streamlines the inspection process gives a single view for all actions taken on a document historically, whether that happens in Kivo or outside of Kivo.
The final piece to this is being able to maintain source and renditions of a file that you are getting back from the partner system. This is becoming increasingly important with changes in Europe with CTIS, requiring that documents be redacted that go into the European Clinical Trial Portal. So in Kivo, one of the things that we've done from a design standpoint is that we've made it possible for files to have multiple source and renditions for every version, which gives us the ability to identify the source of a document that is ingested into the system. If there was a PDF generated by the partner system, if there's a redacted version of that PDF that was created automatically or manually, and maintain all of that as part of each object in our system. The import phase is by far the most complicated, the most time consuming, and the most technically intensive. But this is where the rubber meets the road on getting the TMF from the CRO back into your system.
If you advance, Marion, to QA, we'll talk about two areas that you would focus on in the QA process. The first is some form of automated comparison. At Kivo, we generate a report that essentially does a comparison of pre-import to post-import to ensure that, as things come into the system, we can verify documents, both the number of documents and checksums to ensure that there's no corruption. Some systems' exports will generate a checksum so that you have something to verify against, some do not. So it depends a little bit on what that system the CRO is using is able to do.
At Kivo, we generate a report that does that comparison at the document level, metadata level, audit trail level. Then there are various other checks that we do in terms of storage structure, et cetera. But doing that automated comparison, especially for a large trial where you could have tens of thousands of documents, is super critical to ensure that you have a baseline for the quality of what came in. Then we do a manual verification on a percentage of content to verify the results of that import and ensure that everything comes in correctly. So that's the QA process.
If you take a look at the next step on managing the content, we can take a look at what we actually do directly in our system to manage content and access for the TMF. Even though the trial is done and the CRO has handed it back to you, it's very common that you'll need to continue to manage missing content that was delayed coming from the investigator site, any updated safety information, and revisions received post-study.
There's a handful of content that, even if the study is over, you still have to manage some subset of content. In Kivo, this is effectively running on our document management system to manage how that is going to work. Since we're pulling this into our document management system and this isn't just like archived on a file share somewhere, you can leverage all of the functionality that you would expect in a DMS. Easily finding and viewing documents, searching the eTMF across CRO or Kivo metadata fields, and then being able to distribute documents and data throughout your organization - or even to partners or other companies that you may be working with. A key part of this that a lot of companies overlook... They say, "sure, we'll take the data back from the CRO. Our intent is to park it on a file share and give everyone read only access." That's great, but doesn't really give you a lot of utility for ensuring that that information is disseminated throughout the organization. That's how you manage the TMF between the time of receiving it through the inspection prior to ultimate archival.
The final piece of this is being able to run an inspection. We've built Kivo from the ground up to support virtual inspections. What we are seeing across our customer base is the vast majority of inspections are now happening virtually instead of in person. If you are receiving your TMF back from a CRO and storing it in a proper system, this also gives you the ability to facilitate that virtual inspection process with a regulatory agency so you can set up the inspector in minutes in our system. You can hide draft documents. If you have anything that you are augmenting into the TMF, you can identify effective dates for documents and identify source documents that may exist in other systems of record. In Kivo, we have a concept of a placeholder where content may be expected but doesn't exist. You can either identify why the content isn't there or if it exists in a different system of record. Point that out to the inspector so that they have a view of the completeness of the trial master file without having to either make assumptions that things are missing that shouldn't be ,or chase you down for every document or every change that they are expecting to see. Giving inspectors controlled access to the TMF is a really key part of facilitating this and ensuring kind of a clean chain of custody all the way through.
If you advance, Marion - the final piece of this is archive. That is maintaining the record of the trial - maintaining the trial master file for the complete duration of an archival period. During that you need to be able to supply/facilitate controlled access to the files, ensure that those are read-only, and have an audit trail, not only of the history of the files coming into that system, but then maintaining an audit trail for any changes that happen during the archival phase. For us, we can perform periodic corruption checks to ensure that during that archival phase files are not running into corruption issues.
For a complete archival solution, often what you would want to pay attention to is if you have any file formats in the trial master file that do not meet ISO archival standards. If so, then you may want to consider converting that content into an archival standard like PDFx to ensure that over the duration of a 25 year archival period content would always be accessible, is not in a proprietary format, or not tied (as an example) to a version of word that's not going to be around in 25 years.
The final piece of this is really thinking through how you're going to gain access to the trial master files - what you're going to do with them, how you're going to ensure that that's done correctly, and how to manage those, manage the inspectors and ultimately support archival.
Final thoughts. You really want to define clear roles and responsibilities. Setting clear deliverables make it easier to talk about quality issues with the CRO. What we see as a software vendor that focuses primarily on smaller life science companies who often are running some of their first clinical trials is that deliverables often are not very clear, in part because the sponsor may not have a solid understanding about how to define those. It creates a difficult situation at the tail end to coordinate and discuss any issues where there may be quality or even process challenges.
Prepare to have difficult conversations about timelines, quality and response to queries. Marion and I are often on calls between a sponsor and a CRO trying to help coordinate the handoff from the CRO back to the sponsor through our system. I think we can say firsthand, those are often awkward and challenging conversations because neither side has fully thought through the implications of how all of this is going to work, what timelines look like and how that's going to be managed. Remember that you both need to be on the same page to meet study objectives. And that is true. The objectives aren't just how operationally the clinical trial is going to be executed, but the TMF is really the entire record of the trial. It's the evidence that the trial existed. That absolutely has to be part of the scope of the study objectives and being able to share that information back to the sponsor. These are the areas that we typically see challenges arise between sponsors and the CRO, and how technology and our experience as a document management vendor on the TMF side, how all of that has to fit together.
Marion, I'll hand things back over to you.
Marion Mays: Sounds great. So just a few keys to success is, begin your trial journey with the end in mind. We want to see your drug approved or your therapy or especially all the new gene therapies that are out there. Start at the beginning with defining deliverables and the quality in the contract.
Agree on service levels. Agree on an escalation path and what remedies are in place. Those storyboards are great things. Agree on acceptable remediation process and timelines. Those timelines are so important because do you really want to take your study back when there's still a lot of things that are missing from it? You need to kind of set those expectations. Establish a TMF plan with quality steps built into it. Establish a meeting cadence and metrics reporting. And please, once again, work with your CRO and vendor. Nobody is trying to make it somebody else's fault. It's more about priorities and maybe a lack of awareness. Let's not assume. Let's make it visible to everybody. When there is a problem, let's talk about it and work through it with everybody.
If I can say one last thing before we log off or if anybody has any questions, I just want to reiterate what Toban said. Right at the end of your study, what is it that you have that shows that you managed the trial appropriately, that you followed GCP, that you adhered to your processes or your CRO's processes, and that really the TMF. It is your evidence of your trial, and it's what you sell at the end, too, if you're trying to divest.
Keep control of your TMF. Know what's happening with it, and be able to produce it when you need to for your regulatory bodies.
I do appreciate everybody who attended today. We love sharing our knowledge and experience with everybody, and hopefully you'll join us again.
Toban Zolman: Thanks, everyone. We appreciate it. Have a great day.
