In this webinar, Kivo CEO Toban Zolman and SVP of Clinical Marian Mays discuss the differences between an in-person inspection and the more recent virtual or hybrid inspections. They cover the unique challenges and opportunties that virtual inspections present, and suggest best practices to maximize your changes for a successful TMF inspection.
Key topics covered:
Watch the entire session or read the complete transcript below. For assistance with TMF management, migration, or storage, feel free to contact our team at any time.
Full Session Transcript
Toban Zolman: Welcome, everyone. Thank you for joining today's webinar on inspection readiness around eTMFs. My name is Toban Zolman. I'm joined today by Marion Mays.
Without further ado, we can dive right in. Marion, if you advance to our agenda slide, I can talk through what we're going to focus on today. Marion's going to talk about inspection readiness and virtual inspections, what trends we are seeing with the transition from in-person to virtual inspections, how to prepare for those, and some solutions and tips. I'm going to share how we address virtual inspections through the Kivo software platform, more as a reference point for you as you look at developing your own business process, working with your existing tools, et cetera. Then we'll finally wrap up with some takeaways.
A quick introduction about today's speakers. My name is Toban Zolman. I am CEO of Kivo. I've spent about a decade in the regulatory space and worked with a lot of the largest pharmaceuticals developing submission and business process for global submission management. As I said, I'm joined today by Marion Mays. Marion has over 30 years of experience in the clinical space and has seen it all by working for sponsors, CROs, software vendors, and most recently, helping life science companies prepare for and survive virtual inspections. So without further ado, I'll turn it over to Marion.
We wanted to start today with a quick poll to help us present the best material possible and understand if all of you have experienced a virtual inspection. We'll give everybody just a minute to answer that, and then Marion will end the poll and integrate that into her presentation. So, Marion, I'll shut up and turn it over to you and let you drive things from here.
Marion Mays: Great. Thank you, Toban. Thanks for allowing me to speak today.
It looks like the poll's over. We're seeing is that there are some people that have been through virtual inspections, and we have a lot of people that have not. So hopefully today we can give a bit of insight as to what to expect, how to prepare, and how to put some things in place so that they're successful during their inspections. Looks like we have a couple of people that are preparing as well. So that's good. This is really good timing for them. So thank you, everybody, for participating in that poll.
Let's talk about what an inspection is and talk about what does it really mean. What it an inspection? It's the act of the regulatory bodies coming and reviewing the documentation associated with your clinical trial.
Because of the pandemic, one of the things that was put in place was virtual or hybrid inspections to keep that social distancing going on. But it's really about being able to present information about the trial for approval and acceptance by the regulatory authorities.
Next, inspection readiness. Everyone talks about inspection, inspection, inspection. Inspection readiness is all about what we're going to actually accomplish, which is getting this drug, device, or therapy to market. We need to start with the end in mind.
What is the purpose of the trial? What is it that we need to put together in order to do that? Starting at the beginning really helps set yourself up for success. So another quick poll, and I promise this is the last one for quite a while. I want to know where people are in their planning. Are they enrolling sites at this point in patients, or are you at the end of your lifecycle? Looks like we really got really good participation on this one. Sharing the results from this, it looks like there's a lot of people that are enrolling, so they're past that planning stage and they're not really ready for that inspection. But there's a few that are closing out. We've got a lot that are in the midst of actually doing everything. This is the tough part really. So now what do you do? How do you know that you're ready?
So, preparing for that inspection. It's important to understand what's going to happen. It used to be that you waited for the inspector to show up at the door, make sure they went through security, your standard processes, and then you would make sure your facilities were ready and inviting for them. You had what we call the back room and the front room, and all those things put together where you were hosting these individuals. A lot of times it's more than one inspector. An inspection used to mean preparing for that. Putting things in place for all those people to show up and invade your own space for a couple of days typically. Putting all those things together so that you are ready to present, discuss and prepare.
Now, we're shifting to a remote or virtual inspection, or sometimes it's hybrid, meaning that the inspectors will send stuff ahead of time, ask for things, and show up at some other point in time after they've reviewed a lot of data. Before, you had to wait till they showed up the door. Then you had the opportunity to control the situation. At this point in time, they're controlling a lot more. The inspectors want to have access to your systems. They want to be able to review and look at things all on their own and not have you control the messaging. It's a harder to manage the message. So it's becoming more and more important that you have all of your documentation in place, that you have your systems in place that support your processes so that you're able to be more successful in getting your drug or therapy or device to market.
Hybrid and virtual inspections are here to stay. Many of the regulatory bodies, especially the UK / MHRA, have stressed that they have found them to be quite helpful in making sure that they have the appropriate time to review all the documentation. The FDA has also indicated that they like the ability to have data and information readily at their hands to be able to review and evaluate the therapies and the drugs, rather than having only that one- or two-day review time period.
With that, inspection readiness has become very important task. A lot of resources are put into this. Remember that inspection readiness is all about preparing for the end in mind. It's important that you're planning, you're organizing, and you're getting yourself ready from the very beginning of your trial to make sure that you have everything in place to make your inspection a more comfortable experience, not just for the inspector, but for yourselves and your teams and to minimize the disruption that happens during an inspection. It's important that your documentation, your eTMF, and all of your TMF documentation are able to be inspected at any point in time.
We talk about science being a risk-based approach. The regulatory bodies expect all of your tasks to be risk-based as well, the quality of it, but also ensuring that things are in place where you're checking it. Doesn't mean you have to check everything, right? But they expect you to have a program in place where you are doing appropriate oversight, maintaining your systems as well as the documentation, and be able to present that at any point in time. Nothing's ever really perfect, but putting things in place where you're able to spot check, look at things, verify and validate the information is really what's important. It's all about the evidence. Make sure that you have the information available in a way that an inspector or regulatory body who doesn't work in your system and doesn't know all of your processes and procedures is able to evaluate the evidence that you are presenting to them in a manner that makes sense to them as well. Having consistency and clarity is really important. Make sure that you're able to show all the activities and processes and decisions that were made during that trial. Have all of that readily available for them.
So what is the TMF? Well, the TMF is more than just your eTMF, but it's ultimately the evidence of your trial. It is where all of the information data is stored that allows a regulatory body to formulate their decision on an approval of your product, therapy or device. That's why we say inspection readiness is so important. The EMA has a very good description of what they expect the TMF to be, and that is the collection of essential documents that were used by sponsors, CROs, investigator sites and institutions that helped make the decisions about the trial. It's the evidence of the trial. It's where a regulatory body can go and evaluate the merits of the trial.
Of course the most important thing of any trial is GCP, right? Good Clinical Practice is about making sure that we adhere to safety and data integrity for our patients.
Defining the TMF really important. You need to make sure that the TMF is not just your eTMF. It is a huge part of it, but all of those systems that you have used along the way to collect data, even if it was a safety system, a regulatory system, or your usual data management system - it's really important that you are able to have that evidence in a way that is readable and accessible to evaluate the study data. The TMF is all these things put together and being able to show the evidence of the activities that happened during your trial. A lot of it is collection of things that were created or generated during that trial. Some of the most important things are correspondence. We have a tendency to forget about that email that we seem to use on a daily basis where we do make decisions and provide direction around activities associated with the trial. We can't forget that all of that needs to be in a place that is controlled and available for an inspector to review because we want to ensure the integrity of that data. So within systems you'll see robust audit trails that shows who put a given document into the system, who touched it, and who actually made any changes, updates or modifications to it, allowing an inspector to be able to evaluate the integrity of that information that's being presented to them.
As part of all of this, I like to talk about all those essential documents. It's not just what's in E6 Section 8 of the GCP. It is really about all those other documents that support it. R(2) was very specific about how they outlined all of the information beyond what was in Section 8. In R(3), they're further defining some of these essential documents that demonstrate the activities that happened during the trial, the processes and the procedures that were used during the trial, how decisions were made, and can you actually show that it is authentic. I think where a lot of people get concerned is that they don't have a system that supports their ability to provide evidence that these documents are original, are authentic, and they are the same documents that were used throughout the trial to show evidence of the activities that occurred. Have a system that supports you with all of this so you are able to demonstrate the information that you are providing to the regulatory bodies is authentic and the true evidence of the activities that occurred during your trial.
I thought it would be good to outline, what are the steps to successful management of all of this information? Clinical records and clinical data can be a bit harrowing in that it really encompasses so much. It's everything that's occurring for the trial. How do you manage it? How do you keep it straight? Are you meeting the spirit of the regulations, especially with how you're managing it? All of this can be daunting in a lot of ways. One of the things that I suggest to everybody is, especially for your TMF (because, remember, it's more than just your eTMF) is that you define your index. The listing of what needs to go into your trial master file...what is all the information and all the data that you're going to be collecting?
The TMF reference model is a good place to start. It's been around for quite a few years now and has been revised as needed to fit within the regulatory requirements for a lot of different types of studies. Defining what your structure should be and defining what those documents that are part of your trial master file is really a critical step. Then understand where all of those documents are. If they're not all going to be stored within your eTMF, what are the other systems that are out there? How can you connect all this information? How are you going to manage all of this? Is there ability to connect your systems or are you going to do some of this manually? All of that needs to be defined at the very beginning.
Bring in other experts to help in all of that, developing what needs to be filed, because it's not just clinical! It's also your data management, your safety, your stats and your medical writing. All these people contribute to your trial master file. All of these functional areas have documentation that they create and generate. Some of it is just reporting that all needs to be well maintained and captured. So consider bringing them into your discussions on how you're going to manage all of this documentation and where it's ultimately going to be stored.
Don't forget to evaluate your processes and your procedures, because one of the things that the regulatory bodies look at is how are you performing oversight of your vendors, but also how are you ensuring the processes are being followed? Do you have QA that's doing spot audits? Do you have your project teams that are going in there and doing spot checks and making sure that the CRO that they are working with actually is uploading the documents in a timely fashion? Are the decisions that are made actually filed within the TMF? Bring all of that together and look at your dashboard. Double check, just to make sure that things are functioning as they should.
Ensure that your study teams and your functional teams are really storing the documents where you have agreed they're going to be stored. Perform checks to make sure that everything is in place. Then of course, let's perform a risk-based sampling. Inspectors don't expect you to check everything. And not everything needs to be checked on a regular basis. But having those checks in place and making sure that documentation is flowing in a way that it is intended to and that those documents are being filed appropriately and can be retrieved, that's all very important. That Part of setting up yourself for success for an inspection.
Demonstrate that sponsor oversight. I mentioned on the last slide a bit about checking on your CRO. You need to check on your vendors where you have delegated tasks. It's not that you can't delegate to them. You can hand over responsibilities, but ultimately, as a sponsor, you're still responsible for the activities that are associated with your trial and the documentation that's being generated to support it. All of these things need to be checked. As the FDA says, trust but verify. Trust that they're doing what they have contracted to do and that they are following the procedures that need to be followed. But as a sponsor, it's a critical part of inspection radiness to ensure that it's actually happening in the way that you expect it to happen, and that the information that you as a sponsor ultimately need in order to get your drug, therapy or device to market is actually being appropriately managed so that you are able to demonstrate and provide evidence of such.
Make sure that you're checking on the audit trail. Make sure that it is discoverable and have the pieces that show who put it in and what's happened with it. Just do a check. It doesn't matter how you do it, just make sure that you document it. You have to indicate when you did these things. If the system doesn't show that you did (because some systems are great and it will be recorded on the audit trail that you looked at it) but make sure all those processes are being followed.
Then when it comes to virtual inspections, how are they different? The main thing to keep in mind when we talk about virtual inspections and what does that ultimately mean when it comes to the eTMF and the TMF as a whole is that nowadays virtual inspectors ask for access directly. The FDA is working on a new process where they will be able to request direct access as well. They want to be able to navigate and find the information on their own. So it's really important that you have a system that allows them to do so and that it's built with them in mind so they can navigate and see many of these documents on their own. The system needs to be understandable as they will be looking at audit trails.
The EMA loves to look at the audit trails and see who has touched this document. They want to see if their clinical project manager has been into the system. But they also want to see what has happened with the documents. This is all part of how they review and evaluate data integrity so that they are able to understand the lifecycle of that particular document. Where did it come from? Who put it into the system and what changes were made to it? Validating the integrity of the information that they're looking at is typically done by the audit trail review process. The key thing is that inspectors should be able to self-navigate and be able to see the documents that they need to in order to evaluate the integrity as well as the information the documents contain.
Other things about virtual inspections...They're no longer going to be sitting in front of you and asking you little types of questions. A lot of questions come through either an email or a chat. So think about how you're going to interact with them. What platform are you going to use? How are you going to help them find the documentation that they need if it doesn't seem to be appearing for them in the way that they are used to navigating?
Ideally, have something similar to Zoom where you can more readily interact with them while they're reviewing information. This gives you the ability to see the expressions on their faces as they're reading information. At times you might be able to actually see exactly what they're looking at be able to course correct before it becomes a finding. Remember that you have a lot less control over what's happening and how they're reviewing things when it's a virtual inspection as opposed to in person, because you're no longer managing what they're actually looking at. You're no longer controlling the documentation that is flowing into the room and the individuals flowing into the room as well. They can have more disruptions. I expect my dogs to bark at any moment. I'm sure that other people working from home these days have that same type of interruption that happens and being able to control that becomes harder and harder in this virtual world.
A big difference between a virtual inspection and an in-person inspection is the control that you used to have. Controlling the narrative has become a harder job because of the ability for the inspector to review on their own.
A few other pointers. It is the inspector's expectation that they be able to navigate on their own. They should have access to the eTMF system and be able to click on the documents that they feel that they need to look at, then look at that audit trail of that document. They should be able to then bring up any other documentation that they feel is appropriate that is stored within your system. If you don't store everything in your eTMF, they may ask to be granted access to those other systems. You need to think about how you're going to do that. You'll also need to provide them evidence that you did that oversight activity that you did do spot checks on your vendors and be able to provide them evidence of that.
They'll also look at the audit trails to see when these documents were filed. Were they filed in a timely fashion? "Timely" can be very subjective, but typically what they are looking for is to show that when the decision was made, shortly after that the document was placed into the TMF. If a decision was made to change something, that people's training was done in a timely fashion as well. All of these things need to be readily available for inspection and in a system that they are able to navigate and be comfortable in. If you are unable to provide access, it's important to be able to have a good narrative as to why and also how you're going to support them. Is somebody else going to navigate for them? Do you have an SME in place that knows your trial well enough to be able to simply pull up the documents that the inspector is requesting in a fashion that is quick and easy and not disruptive to the flow of the discussion?
Make sure that all of your metadata is updated and complete, that there aren't any gaps, so there's not questions. Make sure that you're able to discuss any of those issues that might be found along the way. So if you've made decisions about your eTMF system and how you use it, make sure that it's clear to the inspector when they ask questions that you're able to discuss that.
Let's talk a little bit now about inspection preparedness. We've talked a lot about inspection readiness - inspection readiness is all of those things that you're setting up for success at the beginning of the trial, throughout the trial, and during closeout to make sure that you have all of the documentation in place, that you've collected it in an appropriate timing fashion, and being able to articulate and document those decisions. Training has been well documented. Everything's been put in place that allows you to clearly show that you had control over the activities and that you had GCP around patient safety and that data integrity...being able to provide all of that upfront. Now it's time to prepare for that inspection. If you've done all of the inspection readiness activities, getting prepared for that inspection becomes a lot easier, because you know the story of your study. You know the activities and the events that happened during your study, and you're able to speak to them. If you're prepared, you should not necessarily feel relaxed, but you shouldn't feel anxious about your impending inspection.
When that inspector walks in the door (virtually or otherwise), you should feel confident about talking about what happened during the trial, even when things didn't go right. It's important that you document what didn't go right and what you did to remediate that or prevent it from happening again. You'll hear QA people talk about CAPAs all the time. CAPAs are really important because they show that you saw that something wasn't right and that you did something about it. Have some confidence speaking to the events and the activities that happen during the inspection. Be able to talk about the documentation, where it's stored and how it shows evidence of the trial and the activities that happened during the trial.
I like to talk about storyboarding. You can do storyboarding the entire time that you are conducting your trial. Storyboarding is really about documenting the events that happened and what you did around that. Nothing's perfect. This is science, and we all know that things are sometimes out of our hands. Not everything is going to go exactly as we expect. Otherwise there would never be any amendments to any protocols throughout our studies. Be able to talk about the events. What happened and what's the differences between what you did at the beginning of the study and at the end of the study. Those storyboards can be very helpful as you prepare and bring to the forefront all those activities. Because now we're at the end of our study, right? We want to get this drug or therapy or device to market, and that's what we're trying to focus on. We need to be able to provide all of these things to a regulatory body for their review and acceptance of the trial. Make sure you have your storyboards ready and if nothing else, use them to prepare your team so that everybody's on the right page. Make sure that your CAPAs have been closed and that your processes have been updated to show due diligence on the activities. And watch out for those hazards! The hazards come in when you didn't use your system the way that you said you were going to. You didn't follow your procedures the way that you were supposed to, or that there was an event that happened and you didn't clearly document what you did about it. We all make mistakes because we're all human, but documenting and writing it down is really important.
In your virtual inspections, there's the additional challenge not having everybody in one place. You just can't go to the back room as we used to and talk to people. You're going to have to get them online and talk about what happened and see if you can come up with the information that you need to speak to the situation that the inspector might be asking about. Be prepared for the unexpected. We all have technology problems at times. We never really know when it might occur. Be prepared, have a backup. How are you going to do this? Whether you have multiple people having access to things that will need to be shared with the inspector, this is all things that need to be considered.
The other thing that's important is that end-of-day wrap up. Have conversations with your internal team about how the day went, things that people are concerned about, and how you're going to address the open questions that are still there. Follow up activities still need to happen. How are you going to start pulling all of that? Are you going to put that on a shared drive? Are you going to provide links to the documentation this way (which is what I recommend) so that you can clearly show that it's stayed within a controlled environment? At the close-out meeting, are you prepared to try and mitigate some of the concerns that an inspector might have around your processes and procedures? Again, those storyboards become an important part of that.
Building a proactive inspection process is critical. Using your people, your processes and your technology, all of these three things need to work in tandem and in sync together. It's a well-oiled machine to make inspections a success. Make sure that you have people that are responsible for all of this. Make sure that you have identified those people that need to be on the team. Make sure the training is up to date and that everyone has been trained.
In your processes, it's good to evaluate and reevaluate. As I said before, set yourself up for success. Have that TMF index in your structure so that everyone understands how everything was filed, where everything is stored. That comes down to your TMF plan. How are you going to manage all of the documentation for your trial master file? Not just what's in your eTMF, but in all of those other systems that are used for data collection, because it could even be your ePRO and conduct those regular reviews, those spot checks, that oversight.
Don't forget to document that you did, when you did it, how you did it. Maybe you have a procedure that you're using to do it. It could be something as simple as a checklist, as long as you're going through and doing those activities as you state that you're going to. Then technology...technology is so wonderful today. So many good things out there. Leverage your technology, utilize it to its fullest. Just remember that you may need to revise your policies and your procedures in order to better utilize your technology.
Let's talk a little bit more about people and setting up your inspection preparedness. Clearly define roles and responsibilities for those who are going to be on that inspection team. Make sure they have access to the systems that they need to have access to and that they understand how they work. Think about access. How are you going to grant the inspector access, and what is it that they really have access to? Have you made that decision that they are going to have access to everything and anything? Or are you going to give them access to those documents that are final and to the audit trail to show how they were managed?
Then we have the process, right? Your TMF plan and your index or your roadmap, how your workflows work, and how you're utilizing the system and your document submission. When you're going through doing your spot checks and you find things wrong, what is the timing to get that fixed and who's going to fix it? If it's the CRO, how much time are you giving them to re-collect that document or to fix that document? Your TMF completeness...are you staying on top of it, making sure you have the documents in the system for the time period of the trial? Whether you're at the beginning and middle or end, do you have the right documents in place at that point in time of your trial?
Technology. So, technology is critical to all of this. It's really important that it works for you and that you're leveraging its ability to actually support your inspection readiness and ultimately your inspection preparedness. Utilize system functionality, your dashboards, and the different features to help you file things appropriately, and make sure the audit trail shows what needs to be available for an inspector to show that it's got good data integrity.
So what do you want for your eTMF system? We all want a lot from it. It needs to enable active management of your TMF. It needs to give you the tools to be able to see what's happening within the system and what's going on. Those dashboards, being able to see where you're at with TMF completeness...it should streamline your operations. It shouldn't make things more difficult. It should make things easier. Simple. An eTMF system shouldn't pull on all of your resources. Make sure that the right people are utilizing the TMF appropriately. Make it fit-for-purpose; don't use a system for what it's not intended to be.
Now, I've talked a lot, I've said a lot. So hopefully now you're ready to get started. So, just a few key takeaways and I'll hand it over to Toban.
How do we begin? With the end of mind. So, planning, planning, planning and planning. Make sure you have all that stuff in place. Conduct your ongoing reviews and oversight activities, especially of those vendors, too. Make sure that people understand where the documents are, how they're stored and when they need to be in there. Establish a plan for that regular review. Have an inspection process. Understand how inspections are going to flow within your organization and who does what within all of that. Consider conducting some mock inspections and interviews with people to see if they understand the story of the study. Then make sure everyone knows their role on inspection day. And please don't forget to work with your vendor. They're there to help you. Give them the opportunity to know that you're having an inspection, and you'd be surprised how much they can actually help you with that.
With that, Tobin, how about if I hand it over to you and you can talk about how Kivo has done some wonderful things?
Toban Zolman: Thanks for that. I appreciate it.That was all incredibly helpful.
I wanted to take just a few minutes to provide some visuals and concrete examples of how Kivo is working to support virtual inspections and inspection readiness in general. I think we're in a unique opportunity because we were able to build our eTMF product post-pandemic. We got incredible feedback from folks like Marion, customers, et cetera, who had been through virtual inspections, some successful, some not, and really build the Kivo eTMF tool starting with the end in mind. Our initial use case that we supported in the eTMF product was virtual inspections. So I want to share how we have taken a lot of the best practices that Marion talked about, implemented it into the Kivo platform, and how that would look in your own tool set, how to adapt processes to kind of reproduce some of this if you're not a Kivo customer.
One of the first things that we focused on was building and organizing content in a predictable structure. We leveraged the eTMF reference model for structuring those documents. You can see what this looks like in a screenshot. Marion talked about inspectors really wanting the ability to self service and self guide their review of the TMF. The TMF Reference Model is a great way to do that. It has section numbers that are well understood by inspectors and generally builds a very logical structure that you can reuse between studies, across sponsors, et cetera. The first thing that we really focused on was that structured organization.
If you advance to the next slide, the other thing that we really focused on was being able to demonstrate or at least understand completeness of the trial master file. The way that we have done that is through a series of features that funnel up into dashboards that identify what documents exist, which documents are expected to be arriving, when those dates are that you can expect them, who they're assigned to, all of those sorts of things. So if you go back to the concept that Marion talked about around developing an index for your TMF, the way that we've effectively implemented that in Kivo is by taking that TMF reference model and feeding that based on the type of trial you're doing with what we call placeholders. Then content flows into those placeholders over time. This has been a really effective way to surface, both to the sponsor and to the inspector, the state of the trial master file, completeness, et cetera.
The second piece is explicitly defining when you have content that is required and when you have content that is not. In some cases, you may identify documents, data, et cetera, that are part of the trial master file, but may not exist in your eTMF system. They may be available with the CRO. They may exist in a different system of record if it's something like clinical data. Being able to explicitly identify for the inspector when you have content that's included or excluded, and if it's required or not, goes a long way to helping them get an understanding of completeness, your intent, and just generally understand the narrative that you're attempting to portray.
One of the pieces of feedback we got consistently when we talked to sponsors was this tension that exists between the inspector and the sponsor because there are competing priorities. The sponsor wants to control the environment and control the situation. The inspector doesn't want to feel controlled. They want to feel like they have full access to all of the data. Being able to give them access to the same system the sponsor is using to manage the eTMF, but surface the right data in the right spot makes a big difference. If you're giving the inspector access to your core eTMF system, you need to ensure that content that is flowing into that from investigator sites really has guardrails. They should have the ability, from a process standpoint, to be efficient and load data in as it makes sense, but at the same time have that come in with predictable naming conventions, predictable content, predictable timing. In Kivo, the way that we've handled that is to add specific roles for investigators that limit how they can interact with content, especially uploading or creating new content, and having that go into predefined locations with predefined naming conventions.
All of this comes together in how we present all of this in the application to inspectors. We make it possible to set up inspector accounts in minutes, and then we surface a view of the eTMF to them. They aren't in some segmented part of the system, but it's a curated view. We heard multiple stories about sponsors that were using legacy eTMF systems for virtual inspections. Those systems were created for the sponsor to manage the TMF, not for the inspector to come in. So the inspector had access to draft documents and things that created confusion, uncertainty, and ultimately led to inspection failures. We wanted to enable our customers to avoid that.
So although the inspector has direct access to the eTMF system, I would say it's curated access. We hide empty folders so that there's not confusion over where there should be content or where there shouldn't. We hide draft documents. When we show approved versions of documents, we are very explicit. You can see in the screenshot here with the arrow when those versions were approved so that it is very clear if that inspector talks to investigator sites, visits investigator sites, they understand which versions of a protocol, for example, were effective at a given point in time and can triangulate records and data that align to that.
Then the final piece of this that we showed in a prior screenshot is simply identifying when particular content exists in a different system of record, or with a partner, or at an investigator site. All of that gives a really clear roadmap for the inspector to know exactly what they're looking at. It reinforces confidence that the sponsor is adequately controlling and representing all of the content that goes into the TMF in an effective way.
Fnally, we wanted to just end with a few tips. We really recommend that you leverage your systems' functionality and you'll notice where the apostrophe is on "systems". The expectation is that you would have multiple systems that are part of all of the content and data that goes into your eTMF. So leverage those systems' functionality as effectively as you can, and really be prepared to discuss how you use those systems. Discuss your process, discuss the challenges and limitations of those systems with the inspector. One of the pieces of feedback that we heard as we developed our platform was that level of transparency really is key, so that the inspector understands not just the what, but the how. And obviously, as Marion talked about, you need to have proper processes wrapped around everything. But our assumption is that if you have those processes in place, the ability to be transparent about usage, process and challenges is really effective as a strategy with the inspector.
Then the final thing that we encourage is to work with your vendors to ensure that everyone is aware of your inspection and find out how they can help support you, whether that's software vendors, inspection sites or investigator sites, or anyone on the clinical data side. Build a strategy across all of your partners and suppliers to ensure that you have all the pieces. Everyone is on alert and ready to help you and you can navigate the inspection in a timely fashion.
With that, we want to thank you for your time today. We are right up at the top of the hour. If you have any questions, feel free to put those in the Q&A.
I want to thank Marion for the insights she shared today. That was all incredibly valuable. And thank you to all of you who joined and spent the last hour with us. I hope that you got some insights and feel more prepared for any upcoming inspections. So, thanks a lot, everyone. Have a great day.
Marion Mays: Thank you everybody. Appreciate it.