In this webinar, Kivo CEO Toban Zolman and SVP of Clinical, Marion Mays outline the implications of the upcoming requirement to leverage the CTIS portland for all clinical trials taking place in the European Union. This webinar discusses:
Watch the full session or read the complete transcript below. This session summary is also available as a whitepaper, which can be downloaded here.
Full Session Transcript
Toban Zolman: Thanks. I want to thank everyone for joining us for today's webinar focused around navigating the new EU CTIS System for Clinical Trials in Europe. In today's webinar, we're going to dig into CTIS as well as the regulations and the system. We're going to talk about how TMF affects processes and the implications for sponsors and CROs in utilizing the new system. There's a host of things to consider with CTIS and some challenges with that. Then finally, we'll talk through some solutions and tips for how to support CTIS and accommodate some of the challenges.
To introduce ourselves, my name is Toban Zolman. I'm CEO at Kivo. I've spent my career in software development and regulatory and have worked with a large number of pharmaceutical companies around the world to develop regulatory business processes. I'm joined today by Marion Mays, who is Senior Vice President of Clinical here at Kivo. Marion has 30 years of experience on the clinical side, working in sponsor organizations, CROs, and software companies, all supporting clinical trials and trial master files. She's got kind of a wealth of experience to share with us today on how CTIS is going to impact kind of all three of those areas: sponsors, CROs, and technology and supporting that in the coming year.
With that, Marion, I'll turn it over to you.
Marion Mays: Great. I'm actually going to start with a poll just to get an understanding of our audience and who's actually participated in the CTIS system, have had some experience, or not are preparing to do so.
Excellent. Looks like we've got pretty good participation, Toban.
It looks like people haven't yet experienced a CTIS system, and some that are preparing to do so. I think our webinar today is quite timely for these individuals and hopefully we can give them some insight as to what's going on with that.
Let's set the stage for what this is all about. There was a regulation that actually became available to everybody back in 2014. It has taken some time for it to be absorbed within the world of clinical trials and it officially became effective in January of this year, in 2022. It repealed the directive that was out there that discussed how clinical trials needed to be managed, including the documentation associated with that clinical trial, which is one of our focuses today.
In 2023 [this regulation] is going to enforce the use of the portal that has been established to request the ability to conduct clinical trials in the EU, and that's the CTIS portal. We will be navigating some of the challenges and talking about that.
The clinical trial regulation, once again, replaces the trial directive that's been out there for many years. It was released in 2014 but did not become effective. That's pretty normal for the EU to publish the regulations and allow people to try and conform and meet those regulations, giving them sufficient time to actually do that, which is why it did not become effective until 2022. The main objective around this regulation is to provide better transparency about clinical trials that are being run in the European Union. That transparency allows multiple countries to see the same information that is coming from the sponsor as well as the outcomes of the trials, also allowing the public to have an understanding of what the trials are happening and what they're about.
It gave better clarification on the documentation requirements, including language requirements, so that you would know whether English was going to be okay across all of the countries or whether specific translations are needed in each of the countries so that you can be prepared to be able to submit everything the way that it needs to be across the board. It also has clarified a lot of the archiving requirements. How long do you keep documents for? What is the expectation about access to documents? All of this has now been clarified, especially the expectations around the access to trial data and information.
In the US, we have Clinicaltrials.gov that allows you to see what trials are being run. But in the European Union there hasn't necessarily been a single place where you could go. This is what's giving the public access to that information.
There's also clarification on safety reporting requirements so that it can be more easily determined whether it's an event that you should actually be reporting or not on. The one thing it doesn't do is it doesn't have any inclusion for medical device trials. That's one place that is still left out. They are working on that regulation, but for now, everything we're going to talk about today is really exclusive of device.
With that, I always like to bring to the forefront the areas of the regulation that we're really focusing on today. That's article 57, which talks about the trial master file. What does that mean and what inspectors are going to be kind of looking at, and what their expectations are around that? Also the archiving of the clinical trial. What do you do with it during and after and for how long and what does that all mean? So yes, it's 25 years. The directive used to state specifically that you need to have a named Archivist. Now it states that you need to have individual roles assigned that are going to manage this trial once it's been closed and control access to it.
Now, the Archiving requirements. They've been codified and yes, it's 25 years. Member states that participate in the trial can ask for specific documentation to be kept longer or purged either way, depending on what that data is, especially healthcare records. Records shall be maintained in a way that makes them accessible. That means that at any point in time, competent authority can request to have access to those records and you must be able to make them accessible to them. Doesn't specify that it must be electronic, but it's assumed since everything now needs to be electronic. They didn't necessarily put that word in there, but they should be able to look at the information virtually, which is in there, which means that it should be electronically.
Again, sponsors must identify individuals. It doesn't say "named Archivist" any longer, it just says individuals responsible for managing and maintaining the documentation. It does specifically state that access should be limited to only those individuals that are named.
Transfer of the TMF must be documented. So anything that you're doing, whether you're transferring it, moving it, or changing systems, you need to make sure that you're appropriately logging exactly what's happening, which is where they also state that any changes or alterations to the TMF must be traceable. So that audit trail becomes a very important feature.
Let's talk a little bit about the CTIS system. So this is the portal that you're now required to use starting in the end of January of 2023. It has been available this entire year of 2022. We'll talk a little bit about some of the experiences that people have had and some of the challenges that exist out there later on during this webinar. But as we can see, this system is a mechanism that can be used to share details about the trial request information. So it's the end-all-be-all for communicating with the regulatory bodies of the various countries involved within the EU Union. The point of it is that it's a single entry. It consolidates the effort, technically streamlining the application.
Once you actually upload information and multiple countries can access it, you also get a consolidated approval for your request. There's transparency of information, especially for public awareness. This makes information about the trials available to the public, including the results. Caution, what you upload may become very public very quickly. The CTA process for submission to decision and reporting is all in one place; it's all consolidated. You go to one place to submit and to get your actual responses as well. All notices and alerts all happen through this system. Any requests for information or additional details about the trial is also included in this system.
Toban Zolman: Marion, a couple of questions have come in. Let me surface those up and we can answer those. The first is around archival. Archiving TMF and eTMF. Can you clarify is that for 25 years or not on the TMF side?
Marion Mays: It is TMF inclusive. You may have multiple systems that you're using to run your trial, which all then becomes the trial master file. So your data management system, your safety system, any information that you may be storing in your CTMS...if it's not being moved over into your eTMF system, all of that will need to be retained for 25 years inclusively.
Toban Zolman: Great. One additional question we can take right now. For the documentation for TMF transfer, is this using a note to file?
Marion Mays: I would recommend not, because you need to actually it detail out. [Inspectors] would expect you to have a plan or an SOP in place that would actually outline the activities that happen, how it's done, and the documentation, and then the evidence of that documentation, obviously. To make sure that what was moved actually got moved. It's all part of validation. Also when you're moving the TMF, if you're moving it from a validated system to another validated system, you should have a transfer process in place that is verifiable great.
Toban Zolman: Thank you. If folks have other questions, feel free to populate those. I'll let you keep going.
Marion Mays: Excellent. Okay, so I want to dig in a bit deeper into the CTIS system.
It's supposed to provide efficiency as a single entry point. It's supposed to be the end-to-end electronic application process, and member states can actually collaborate in there. It increasing visibility into what questions are being asked about the trial from the different countries. All of that correspondence and communication all becomes visible to everybody who's participating and allows people to see what's going on. It increases that transparency, results will be available.
Consequently, there are quite a few documents that now need to be written in a way that a layperson can actually read and understand them. Your protocol synopsis would be one of those. Allowing people who don't understand the scientific nature of the trial or are not in the healthcare industry should be able to read the synopsis of the protocol and understand the objective of the trial, as well as understanding of the activities associated with that trial. This also provides enhanced patient safety. So [CTIS] is where all of the information gets to be uploaded to share with all the ethics committees as well as the individual country regulators as well, allowing them to actually see what's going on and to also help determine whether the category of that safety situation as well. It's a unique intuitive tool that facilitates submission applications for multiple trials. Again, it's the one upload with multiple views available.
So, what is the impact? What does this mean? If you're a sponsor or if you're a CRO supporting a sponsor with their submission or running their trial, there's an impact. Paper is not something that you can put into a portal, at least not yet, that I know of. [Your trial] will need to be electronically based. There's new responsibilities for managing these submissions, so understanding how the system works, communications with regulatory bodies, since everything happens within the system itself. You need to log in every day. But unfortunately, you don't get notifications outside the system, so you need to go in the system to actually get your notifications. They have set really strict timelines, so if they send you a request for clarification or they have questions, you only have twelve days to respond, otherwise it'll be logged as a non-response. This makes transparency around proprietary information more visible.
You can request to have a deferral of your proprietary information, but you have to go through a process to do that. Otherwise, within five to seven years, depending on the deferral that you get, your proprietary information will automatically become visible. During that time, there's a transition of ongoing studies from what is currently the directive into the regulation. All of that needs to happen by 2025. So make sure that you mark that on your calendar, that any trial that is continuing to run to 2025 will need to start adhering to the clinical trial regulation as opposed to the clinical trial directive, which means you will have to use the portal. So there's an impact to your current processes and to your current systems - are they able to support some of the things that now need to be done as well as absorb some of the information that's being created by the CTIS system?
And of course there's new document requirements. Your TMF needs to be able to absorb those documents. The extra effort to create those documents is important. Then there's inspection readiness and access to regulatory authorities so they can at any point in time, just like they can today, request access to your trial master file as a whole. You need to be able to provide that. This will also be true for the 25 year retention time period. They can call you up and ask for information within that 25 year period. You need to be able to make it accessible to them.
Toban Zolman: Marion, follow up question related to that 25 year period. Article 58 states that it needs to be 25 years from the end of the clinical trial. The question is what date or milestone would you consider using to key that 25 year period on?
Marion Mays: What I typically recommend is that 25 year time period is once you close your trial, you make sure that everything in your trial master file is all inclusive altogether. In the right place, I guess is a good way of putting it. If you've made your marketing request, you can then start counting your 25 years at that point in time. Obviously you're going to have inspections during that time. So if you are moving everything to an official archive or what I like to call cold storage, which is when only certain people have access to it, I would certainly not do that until you've actually received your marketing approval and had your inspections. So it's a little tricky time frame to kind of pick and choose from, but you can start counting down the 25 years from the time that you've officially closed your trial and started your marketing approval process.
Toban Zolman: Great. One additional question before you move on - related to twelve days on request follow up, does that include weekends or is that purely business days?
Marion Mays: That's twelve business days. It is a little tricky to keep track of those twelve days. Not only that, but also remember there's quite a few holidays which would also impact that twelve days. So you might get lucky and have a little bit more than twelve days depending on when that comes in. But I would keep a reminder on my calendar for those twelve days.
What is the true impact to the TMF? We've touched a little bit on it as we've had some questions, but it impacts what needs to be filed in the TMF because there are new document types. The other thing is [the new regulation] speaks specifically to having a single and comprehensive TMF. So it's really important now to have a single TMF plan.
A lot of times we see sponsors having their TMF plan and their CRO having another TMF plan. The regulatories are actually looking for a single way that the documentation is going to be managed. So it's really important at this stage to start collaborating with your partners. And if you have a vendor that's also supporting you during your trial master file management, it's really important that they're also considered as part of your plan and embedded as part of that single unit as to how you're going to manage your trial master file for study. Remember, since some documentation uploaded to the portal becomes public domain immediately, it's really important that you consider redaction of documentation.
Your processes need to be updated and changed, your document management practices need to be updated...So that redaction, plus updated definition of the TMF. It's no longer multiple TMFs. They're very specific about that. They expect to have a single TMF. They do understand that the sites may have additional documentation and additional requirements for their side and that is perfectly acceptable.But as it must be a single TMF, including if you are partnering with another company, you need to make sure that you collectively have one single TMF that has all the information within it.
What does this mean? Well, typically it means additional resources. Not only that, but skills and expertise are also going to be needed to manage some of these changes. It's going to require (even though it may be streamlining some things) time as well as allocation of individuals, including having to move current trials into this portal. And it's going to require better coordination of document filing between your CROs and sponsors. If you have multiple sponsors working on a product or indication, it's going to be really important that the documentation is cohesive and collective in nature.
Let's talk about the new types of documents that need to be created. The CTIS will now require that you submit documents which go beyond.. You need to figure out how to now put it in a way that the general public can understand it. That synopsis that I indicated...there's several reports that need to be written for the general public so that they understand what's happening with the trial. And don't forget that we need to really be cognizant about personal and confidential data. So all of this will need to be appropriately redacted, especially when publishing results. There are a lot of moving parts to this, which is why additional skill sets needed to manage this are important.
There's a greater emphasis on safety and reporting of safety. It's really important that your safety team is up to date on that, that things are in your sites as well. All of them need to be reporting appropriately.
I love this graphic. I think it shows where we've all been and sometimes feel when we're doing submissions and even the trial master file. So really, what has changed? Paper is no longer something that should be considered. You can't put it in the portal. You need to make sure that you have electronic systems that actually support your activities. All your documentation and data must be available for review and inspection electronically. Inspection readiness and streamlined submission is the goal for all of this, is allowing transparency and allowing the ability for multiple countries to share data and information about the trials and the results.
So I have another poll. Now that we've talked about it, are you ready for this change? Looks like, "yes, we have some stuff. We don't have other stuff," which is kind of expected, right? Even though we knew that this was coming our way, we may not have all taken in everything that needed to be.
Let's move on to the next slide. So what does this all mean?
New skills and training to work in the portal - that's going to be essential for everybody. Understanding what needs to be uploaded, what needs to be included in the eTMF. What can be redacted and what can't be redacted. Especially the new documents, right? Getting those written in a way that is less scientific and more layperson friendly and the long term access and control over TMF documentation. We've been talking about this for many years. We need to get a better control over this. We can no longer send those boxes to Iron Mountain to be stored for years and hopefully be able to retrieve them when we need them. But also we can't just put it somewhere on a shared drive and hope that it stays there. There are more requirements around the archiving and managing appropriately.
Those of you who know me, TMF is my life. What's really important that everyone understands the TMF is really the evidence of the trial. Once everything is done, the documentation that exists afterwards is your trial master file. That actually is what happened.
Now let's talk about people. I talked a little bit about skill sets...you need to better define your roles and responsibilities.Defining system setup and approach, that's really important for the CTIS system. They have a couple ways that you can do it depending on how your organization is set up and also how you're going to collaborate with your CRO, if your CRO is going to participate in uploading anything up into the portal on your behalf is setting up those roles. You can either set it up individually by a trial, or you can set it up by an organization. Make sure you have a plan in place for that, or a direction at least that you're going to go in.
Then the skills and the knowledge. It's a new system, it's a new way of working, which requires new document requirements. It has time constraints and time requirements. It does require a lot of continued monitoring, documentation, and communication. Staying on top of all of that. So once again, logging in every day and making sure that things are moving along as they're supposed to be.
Then the technology right system functionality. To help you manage your TMF, you need to leverage your eTMF and your RIM system as well. Make sure your workflows work for you and that they're compliant. Make sure reporting from your system allows you to keep track of what's going on so that you have inspection readiness, so that you're able to know that you're ready whenever [inspectors] ask to have access. Using your TMF as your source, you can obviously get all sorts of great information for your compliance, but make sure that it really is cohesive and collective. Making sure you have that single system, being able to understand the history of what's going on within your trial. Most important thing is really your audit trail so you have good data integrity and [your trial is] not coming into question.
So what do you want from your eTMF system? Active trial management, inspection readiness, of course, visibility into the TMF health. You want to be able to gain clear oversight and complete management / control over what's happening so that you're mitigating the risks. Streamline your operations to reduce the effort that now CTIS is going to create, especially the time that it's going to take to actually manage it. There may just be one place that you're putting the stuff, but actually there's a lot of active management that needs to go too. So those resource demands are high. Ensure that you have the right people doing the right thing for the right reason, of course. And of course, you have fit-for-purpose technology so that you're not using 10,000 different systems and trying to streamline your processes.
So are you ready? It's a bit complex, it's been working for a while, but it's a new system, new document requirements, new way of corresponding, which I think is going to be hard for some people, and the strict timeline constraints. If you can make things easier for yourself, make sure that you do, but make sure you stay compliant.
Let's talk about a few of the current challenges that are ongoing. The system does not support all the trials. As I said, CTIS doesn't currently support medical device trials. The system currently does not support parallel submissions. And what that means is that you can only do one at a time and you can't do amendments when you have another trial going on. It's a little clunky around that. [It currently] lacks an API, so you have to create a lot of manual uploads. You can't just easily transfer information to upload. Currently the maximum document size can't be greater than ten megabytes, so some documents are going to have to be split. Another challenge for your documentation team. The system has been experiencing significant outages. I'm sure all of you in the regulatory space probably hearing some of the chatter that's been going on in Europe about that. There is a potential to miss your deadlines because just because the system is out - they don't give you any grace period for that twelve days. They're still going to hold you to that twelve day even if the system was down.
Users have faced challenges despite the support that's provided. So some of the users as far as the ethics committees have been struggling to get the right information and be able to see what they're supposed to be able to see to make decisions about the trial for their regulatory space that they're working in. The ability for the system to keep up with demand is a concern for January, as right now only people are using it that want to try it out, where in January it will become a must and have. So there's a concern whether it will actually be able to stand up to all of it.
Let's do one more quick poll seeing how many people are ready for this. Does your current eTMF support the changes that are needed for the CTIS system? Let me launch this poll.
We're seeing a lot of people use a CRO system, which is good...at least system is good rather than paper. Looks like a lot of people are using their CRO system, so that may be a slight challenge moving forward. It'll be important that you work well with your vendor and make sure that your CRO actually is able to support some of those new document types that need to be created and how redactions need to happen. So it'll be important for that capability to be in that system.
Toban Zolman: Does a sponsor need to have an EU presence to register and use the CTIS?
Marion Mays: No, you do not.
Toban Zolman: Great. Thank you.
Marion Mays: They have great training. There's a user manual, there's all sorts of stuff out there to help you, but it's still challenging. It's a lot to go through. Now I'm going to turn it over to Toban and he's going to talk a little bit about Kivo.
Toban Zolman: What I want to do is provide some context for working with the portal and what that means from a software and technology standpoint.
When I first started looking at CTIS, my frame of reference was eCTDs or electronic submissions. I think a better paradigm if you haven't seen the portal is think of it more like interacting with TurboTax. You are filling out tons of form fields manually, you are uploading individual documents, hitting submit on forms, and then they have a workflow engine behind the scenes that routes that content and information out to the appropriate committees, ethics committees, regulatory bodies, and ultimately to the public website. It is a incredibly manual process to interact with the site. Based on the challenges that Marion just articulated around concerns about if the system can even stay up - historical outages, etc - There are a lot of questions on, "okay, how do we reframe our business process and adapt software to support what is ultimately a very manual interaction through the portal." So I want to talk about how we are thinking about that at Kivo and what we have implemented. Quite frankly, we anticipate being incredibly nimble next year, trying to adapt as we expect there will be changes in approach, guidance, best practices and, quite frankly, functionality with CTIS to really support what's going to be a tsunami of activity into the system that they haven't had to date.
The first thing that I want to highlight is just how we are approaching support for all of the artifacts defined in CTIS. Marion referenced these new document types that are expected compared to what has historically been required. We've effectively built these as part of our eTMF system, which is based on the TMF Reference Model. Our storage structure, as well as permissions and additional features to work with investigator sites and stuff. So [we automatically] create the storage structure for all of the artifacts that are going to be expected through CTIS so that you can build effectively project plans for your clinical trial to ensure that you have all of the data needed.
The other thing that we've focused on is redaction. If you think about this from a workflow standpoint, you're going to be submitting content through the portal that either has IP or PII information that you don't want exposed through the public portal. Again, if you bring your mind to TurboTax as you are populating this information, you need to be able to supply and identify which documents are redacted, which ones are not. So if you back up all the way to, "okay, how the heck do we do this?" From a document management or document publishing perspective, we wanted to bake that redaction directly into the Kivo platform so that as you are authoring something like a protocol synopsis that may have redaction requirements that you could do that directly in the system and feed that in a fairly seamless way. Still manual, but as seamless as possible into the portal. The way that we've approached that is (as you can see in the screenshot) baking online redaction tools embedded in Kivo straight into the software, so that any PDF rendition you have of a document, you can effectively redact it and store it in the system.
Then, we have adapted a submission building tool created to hand documents off to regulatory publishers. We've repurposed that around CTIS forms. We've structured out all of the sections that are expected for certain types of CTIS submissions. You can simply drag and drop documents into that from your trial master file or a RIM solution, and then we let you choose what goes in that output. Is it the source file, the PDF, the redacted version of the PDF, and what that produces is effectively a folder structure, a zip file that, again, isn't going to automate anything, but as you go through the steps in CTIS, you have all of the documents in a folder structure that go into each section. You can easily drill into those and rapidly upload files one at a time into the system and identify if they're redacted, not redacted, et cetera.
We've essentially built a predefined structure for all of the common CTIS submission types, which makes that as painless as possible, but still a lot of effort, I think, based on how they currently have it set up. And with no API, no XML backbone or anything like that, it's still very much a form-driven approach.
The final piece of this is on the eTMF side, being able to be inspection ready since all of this trial master file documentation or clinical trial documentation is moving into an electronic realm. The way that we are approaching that is by really having an inspection-ready view of your trial master file and all of your clinical documentation directly in Kivo so that you can give inspectors kind of access to that trial master file view within minutes. You can hide empty portions of the structure, you can hide draft documents, you can identify effective dates and then identify other systems of record for documentation that doesn't exist in Kivo. What we provide to support CTIS requirements is a system that meets the 25-year archival requirements by supporting the platform with appropriate infrastructure and redundancy for formal archiving, creating an inspection-ready view inside the system.
Then finally, as you have identified, you're working heavily with CROs, some of whom own a lot of these systems. It's really critical to define roles and responsibilities between you and the CRO on who's going to be maintaining and archiving this documentation and who's going to be interacting with the portal to get the documentation to the agencies. That's a critical piece. Based on how CTIS ingests data, which is a very manual format, defining those roles and responsibilities with your CRO is important and quite frankly, could have contractual implications depending on when you negotiated contracts with them. If that predated CTIS considerations, then really revisiting that and understanding the cost structure and the contract structure with your CRO is going to be important.
This brings us to another poll which I'll let Marion initiate. We're curious if you have submitted through the CTIS portal today and how you're managing those approval processes. If you're placing those in your RIM system or SharePoint, if you're putting them in your eTMF, or if you don't know yet or haven't yet received an approval. There's also that correspondence that goes back and forth that also needs to end up someplace as well.I know some people have been receiving zip files...does your system absorb a zip file or do you have to unzip it? Just curious to see what people are doing.
Looks like quite a few people have not yet received any approvals. Some people are placing them in their RIM system or SharePoint. People are placing them in eTMF and looks like some people just haven't figured out where to put them. So that's okay. This is all part of the process, right? This is a new experience for everybody, so we'll see how the world evolves with this. So thanks for participating in that.
I'll wrap up with some tips and then throw it back to Marion to close us out.
My worldview is from a business process and a software standpoint. Advice from that worldview is to ensure that you have an adaptable platform. Based on the challenges, based on the approach that they have taken to implement and the general architecture of that platform, we can all expect there to be change this year. So having a set of tools that can be adaptable is going to be important.
Preparing to do manual work is also going to be important.This isn't something where you have software to assemble everything and then it goes through a gateway. You're going to have to assemble and then manually upload those documents one by one.
A redaction strategy is really important and from a process standpoint, it's one that's really challenging as well. If you think about this from a traditional document management perspective and you have source documents that ultimately need to be published and then redacted and you need to be able to retain those redacted copies...how are you going to associate all of that in your document management system and retain that over time? Proactively defining that strategy versus throwing it over the wall to a CRO or a publishing group to do the redaction before it goes into CTIS is going to be important, because it's not like you get an archived submission back like you would with an eCTD in order to retain that for traceability purposes.
Then the final thing, as I've spoken about, is to clearly define roles and responsibilities with your CRO and make sure that there's a plan - both process and personnel plan - to support the redaction, the manual work and all of the platform pieces.
A question did come in which I'll address. Is the acceptability of redacted information something that's determined at the time of review by CTIS or does the sponsor have to provide a redaction plan or justification for the information redacted in an application?
Great question. It probably depends on who might be asking the question from the regulatory body. You should have a redaction plan of your own as to what you're going to consider proprietary information, what you're going to consider to be well and personal identify information absolutely needs to be redacted for anything that might be part of that public view. Really important that that is already in place. If you redact stuff that they feel that you shouldn't have, you will be asked to redo it and repost. So it will come back to you if you inappropriately did it. Also remember that everything basically becomes public five to seven years after the trial is over. So even your proprietary information will ultimately become public unless you can get some kind of deferral, which needs to be through an application process.
Great. And I'll turn it back to you for kind of our final thoughts.
Marion Mays: Okay, great. Some takeaways for everybody...All submissions to the EU must, with the exception of medical device, go through the CTIS beginning in January 2023. I suggest that you make a plan for the changes and include both clinical and regulatory teams in those discussions because it really affects both those teams. And then work with your CRO and partners to have a consolidated TMF plan. Make sure that you're working in unity and don't have diverse ways of doing things and that everyone's on the same page and that everything comes together as one single TMF.
Establish how you are going to manage communications from the CTIS system. It can be very challenging. Understand how you're going to manage those...are you going to do screenshots? Is that acceptable? Not acceptable? Are you going to download and save the files? Are those files readable within your system that you're placing? It's also critical who will manage input and output in the system. Who's going to be your monitor? Who's going to be watching all of this all the time? Who's going to log in every day and make sure that there isn't a notification that you need to respond to?
Update your processes to include the new document types. This will be important going forward. Update your structure and your business rules to accommodate the new requirements. Make sure you understand what needs to be redacted,when it gets redacted and how to save that. Work with your vendor to ensure your system supports you staying compliant. Make sure that it can help you do these things, make sure that you're able to store those file types that you need to store, and all of the other things that come along with that.
I think that's it. I want to thank everybody for joining us today.
Toban Zolman: We definitely appreciate it. One small plug from my side - we do have a companion whitepaper that we'll be releasing with this webinar. We'll follow up with the recording slides and other information after this.
Again, on behalf of both Marian and myself and all of Kivo, thank you very much for your time today. Happy holidays and good luck supporting CTIS as we move into next year.