Regulation (EU) 536/2014 & THE CTIS:
Planning Your Process For Public Disclosure


Ahmed Eldafrawy, Disclosure & Risk Specialist
Elliot Zimmerman, CEO Real Life Sciences


European Medicine Agency's (EMA) Clinical Trial Regulation (CTR)

EMA (EU) 536/2014 puts transparency and disclosure professionals in the critical path. Here are some resources to help you navigate

  • EMA Guidance on CCI
  • Webinar Slides: EMA (EU) 536/2014 & the CTIS - Planning Your Internal Process.
  • Resource Links to EMA for important 536 Material
  • Case Study: (EU) 536 - Clinical Document Redaction in the Spotlight
  • Guide: CTIS Training
illustrated smiling doctor holding clipboard


European Medicine Agency's (EMA) Clinical Trials Regulation Information System (CTIS)

EMA's Clinical Trial Information System (CTIS) is now mandatory for all new Clinical Trial applications in the EU. Below are guidance and training resources for CTIS:

Stay Ahead of Regulator Expectation

Cutting Edge Data Anonymization &
High Speed Redaction.

Are you interested in staying ahead of the increased Anonymization requirements for EMA CTR (EU) 536/2014 and the increased volume of documents you will need to upload into the CTIS (Clinical Transparency Information System)?

Do you want to learn more about new regulations or the changing expectations from EMA?

We are committed to informing the Clinical Trial Disclosure & Transparency community. We educate & partner to advance participant privacy and data sharing. Please reach out with any questions you may have or to schedule a brief 15 or 30 minute chat to discuss moving you forward faster.

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    Webinar Transcript

    Regulation (EU) 536/2014 & THE CTIS:
    Planning Your Process For Public Disclosure 

    Elliot Zimmerman:
    I'm really excited to be here today and want to thank the audience for taking a few minutes out of their schedules to be here with us today. We do have a packed agenda today. And with that, I do want to share a little bit, just about 60 seconds, of introduction to the company. So you know who we are and who's on the other end of the webinar today. And then we'll get right into the agenda and the specific content around 536 and the CTIS. So Real Life Sciences what you're seeing here is our vision. And I'll summarize by saying what we live and breathe every day, is all around protecting personal information, company confidential information, and we develop technology and provide outsourced managed services to help the life sciences industry in these particular areas with various regulatory submissions and voluntary sharing initiatives as well.

    We offer two solutions at Real Life Sciences, the first being RLS Reveal, and this is a real world data solution that's focused on processing using technology like natural language processing and machine learning to evaluate real world data sources, such as social media and produce analytics around patient reported outcomes. Real Life Sciences Protect is our solution that's purpose built around data and document anonymization in support of the various health authority regulations, such as Health Canada, EMA policy 70, now the CTIS and CTR regulation as well. And you'll hear a little bit more about our capabilities further on in the presentation, but primarily what we're here to do today is talk more around regulation 536, and some of our experiences that we can share with you around how you can prepare from a disclosure perspective. Now Real Life Sciences has been around for quite a while.

    About six years now. We've supported various pharma and CRO organizations with health authority regulations for disclosure around Health Canada, PRCI, EMA policy 70, voluntary sharing products. We do this with quantitative risk assessments and using our technology for purposes of anonymization and redaction of various documents that are required for submission. From an agenda perspective, what Ahmed and I are going to take you through today is really in three sections or three buckets. First is a bit of an overview around regulation, 536 in the CTIS to orient everybody. Well, we'll start at a high level. We're going to quickly get into details here specific for disclosure teams that I think will have some meaningful takeaways for all of you. Second thing we'll talk through is considerations for disclosure teams. So what does this regulation really mean? What is the CTIS? How does it impact disclosure teams?

    How will this impact your day to day and what do you need to be preparing for? And the third bucket is going to be around some of the best practices that we can bring to the table from our experience, working with our customers and recommendations around how you can go about planning and executing your first trial in the CTIS. So we hope between these three topics, there's something here for all of you, regardless of your level of experience and knowledge around 536 in the CTIS. So hang with us and please ask your questions as we go along and we will address them at the end of the session. So to get started, the first topic is around, well, what do you need to know? So let's just start very briefly with some basics. So regulation is on the left and this system that supports it is on the right.

    So the regulation that we know as 536, otherwise known as the Clinical Trial Regulation, we'll refer to it as CTR, is the regulation that we've known about and we've known it's coming for some time now, and it's a new regulation in the EMA that went live at the end of January, along with the CTIS system. And this is all around how the EMA is requesting that study sponsors conduct trials in the EU. And I think what's noteworthy here is this regulation specifically calls out and emphasizes the need for transparency around clinical trial information. And that's one of the things that's very different around this regulation. The second aspect is the system itself, and you'll hear us refer a lot today around CTIS. Clinical Trial Information System. This is the tool or the platform that's used in support of the regulation.

    This is where a lot of the change impact occurs for sponsors like yourselves and CROs, and that this is your single entry pointer, your single source of the truth for all of your trial information, starting with a CTA, obtaining your approvals, feedback and Q&A with the health authority, et cetera. So this is going to be your day to day system that you use for all EU submission projects. We tried to outline what it is and what it isn't from a CTIS perspective, so we can continue to drill down into more and more detail here. And then we'll get into more specifics around what this really means from a disclosure perspective. So, first of all, the idea here is that the CTIS will ultimately replace EudraCT, which of course is in use today. There is a transition period, and we'll cover some of those highlights in a moment.

    This does become your single source of entry, if you will, around all your clinical trial activity and management in the EU. This also now serves as a single submission for your dossier, for your trial application dossier, for all the member states that are applicable. So that's a big change as well for your regulatory clinical teams, as well as disclosure. And what I want to call out here at the very bottom, you'll see it in italics, is that the CTIS is also the means for posting and submitting public and non-public documents. And this the CTIS system is essentially the backbone of what will be made public to the general public, that's interested in searching and understanding what's going on with various trials. So we'll get into more specifics around that as well. What it is not is it does not replace your CTMS system that you use internally. It's also not a document management system either. Okay?

    So from a disclosure perspective, and we know that a large part of our audience today are folks that either are in regulatory clinical or disclosure teams. And our focus here will be on what this really means from a disclosure perspective. First of all, personal data and commercial confidential information are exempt from the disclosure requirements in the CTIS. There are options to defer public disclosure, and that needs to be considered when you submit your CTA. However, the public and non-public version documents still need to be submitted simultaneously. The member states will issue their decision using the CTIS. And following the decision around approvals, the public version information will be, at that point in time, made available for public search on the CTIS system itself. This of course is unless there was a deferral that was worked questioned along with the CTA.

    And if that deferral and justification was ultimately approved. So you can see quickly, there's quite a bit involved here for disclosure teams to consider and how they support the end to end process using CTIS. From a timeline perspective, and this of course is an image of an actual EMA slide that's used often to convey and communicate the schedule, this transition occurs really in three stages. The first stage is now in the past, last month, the system and the regulation went live on January 31st. This period that we're in right now, you certainly can, as a study sponsors, start to use the CTIS, get familiar with it, and start to use it for your submission activity. Starting just less than a year from now in about 11 months, all initial clinical trial applications must be submitted through the CTIS.

    So this is the first in very significant milestone that mandatory, coming up in less than a year. Where all your new trials that are starting up need to be submitted through the CTIS. And from there, there's a two year transition until all active, ongoing trials need to be live in the CTIS. And that comes effect January 31st, 2025. So it's a deliberately staggered approach that gives you time to get familiar for your new studies and also work through a plan and a process for how you're going to transition any active trials as of January 31st, 2025. I should note as well throughout our presentation today, you'll see hyperlinks. For example, like this one,` where we're including references to some of the EMA materials that we think will give you even the next level of detail and more information around some of these topics.

    This is a nice visual of the CTIS framework or platform, if you will. The point that we wanted to make here is there is one system that serves as the area where sponsors can gain access through requests, and they can do their work. And the authority, the health authority, ethics committees, do their work as well in this underlying same database, and then parallel to it, or next to it, is the public version website where there's not a login required, but the public has access to search for various trial information That's been disclosed.

    One point we wanted to call out here from the handbook that the EMA has published, is the CTIS will not allow uploading of a not-for-public version document without also having the for-public version document posted at the same time. This is an important consideration as we think about the requirements and your internal processes between disclosure teams, medical writing, and regulatory, to make sure that you have a well defined process for how you're going to work through the timing of that and the coordination amongst your teams. And we'll talk more about that, and some recommendations, in a few moments. So further, on this slide, we took a sampling of some of the documents, of course, that'll need to be ultimately submitted through the CTIS, both in public and non-public form. And one takeaway we want you to have from this.

    This is not an exhaustive list. But it gets into some of the differences between the CTIS system and the CTR regulation and how it's different than what we're accustomed to with other health authority regulations, such as Health Canada PRCI and Policy 70. So for example, right out the gate, you can see here that this process with CTIS starts at the very beginning and it's follows the trial process all the way through with submission of disclosed documents, public facing documents from the start. Of course, with Policy 70 and Health Canada PRCI, we know that these activities for submission typically happen only after marketing authorization.

    And of course they're focused on clinical summaries, and CSR documents, and submitting an anonymization report along with it. So there are some differences, and there are important differences because of the fact that there's going to be significant process implications on disclosure teams and how you're such an integral part now from beginning to end. So with that, the deferral topic is an important one, and the EMA refers to different phase trials and different categories. It's important to understand what the deferral options around disclosure really mean and the impact of this. So Ahmed's going to talk for a few moments about deferrals.

    Ahmed Eldafrawy:
    Awesome. Thanks, Elliot. Yeah. So now we just want to walk you through some of the general principles of disclosure within the clinical trial information in CTIS. As you know now, the expectation is that all the data and documents must be public, but sponsors do have some options to request referrals of documents that are subject to publication. There are a lot of disclosure rules. We also do have a link within this slide deck for you to take a deeper dive into some of those disclosure rules. But just below here in these four, we wanted to highlight a few of the key points for you. So looking at the first one, sponsor will be required to provide justification for the deferral request. And the member state will evaluate the request made by the sponsor to defer publication.

    So basically here, within the forms piece of your clinical trial submission, there are going to be deferral options in place, but the sponsor is going to need to be granted that deferral by the member state. So there is going to be a deferral form, and you provide that justification. And then after the justification is submitted to the member state, it will be evaluated and it will be either granted or not. Second one that we're looking at is number two, deferral rules and timelines are dependent on the category of the trial. So basically what we're going to see is you can see on the top, we have category one, typically where phase one will occur. Category two, where phases two and three will occur and category three, which is phase four will occur.

    So basically the key element here is each category is going to be subject to different deferred rules. And we're going to get to see a table that really outlines what category gets to be deferred for how long in the next couples slides. And number three, deferral of main characteristics is only feasible for category one. Key element here is there's really no deferral options for main characteristics in categories two or three of the trial. So if there are main characteristics that need to be deferred, you only can provide justification for why it needs to be deferred in category one. And then lastly, number four, deferral options range anywhere from the time of publication of study results, up to seven years, depending on the category and the content of the disclosed documents. So what you're going to really see here is depending on what you're requesting to be deferred, that your timeline for how long it can be deferred will be indicated based on the category and the grouping of the disclosed documents. Next slide.

    So right here, so this slide here is going to be in relation to the previous slide. So we talked a little bit about how each category will have different defer rules. So what you have here, the screenshot on the left is going to give those specified timeframes of up to how long a deferral for a category of documents can be granted until. And then the screenshot on the right, that comes from the CTIS website. And it's going to lay out some of the different parameters according to the grouping of the documents and the category of what the clinical trial is in. So depending on the deferral that you've been granted, it might be indicated by a specific radio button, as you can see. Or the user will enter the number of years that they've requested the deferral for.

    So here, we're looking at a few things. So within the groupings of the main characteristic, obviously we mentioned that those main characteristics can only be deferred in category one, but what you have here on the screenshot on the left is just a list of some of those main characteristics that can get deferred. And the screenshot on the right are data fields that must be published, even in the case a deferral was granted. So when we send out the link as well, on the CTIS website, you will be able to see examples of when a specific deferral has occurred to some of these fields, how it would look like that the field must be present, but the document can be approved for a deferral.

    All right. And here, we're just going to segue into just providing an overview of some of the activity that CTIS has received since it went live since the 31st of January. So this just gives you an idea to see for the most part that the activity is increasing from a week to week basis. So as far as the number of logins, the amount of draft applications and the submitted applications. So here's just a view of the metrics to give you an idea of what the activity has looked like for CTIS, since it will lock at 31st of January.

    Elliot Zimmerman:
    Clearly Ahmed, it's still early days. CTIS just launched just less than a month ago, but good to see the data that you've collected here. With that, we're going to do a quick audience poll on one or two questions. John, I'll hand it over to you for that, which I think will help keep this interactive. If you want to go ahead and launch the first one. Great. So the first question is around just how you sense your team's internal organization awareness of the regulation and the CTIS requirements. So if you could quickly select an answer here around your state of readiness, we find this information really interesting, especially we've got a large audience here today. So I think it will be insightful in terms of how different organizations are approaching this. Certainly we have customers that are already hands on CTIS, working through pilot projects. We have others that are getting trained. We have some that are doing process mapping around how they plan to interact with it. So across the board. And we're just curious how you feel your organization is doing so far.

    John Lyons:
    So it looks like, Elliot, that we've got responses to all of them so far. The leader though, however, is the first choice we are monitoring the CTS rollout carefully. That's the majority of the folks answering that. Runner up, my organization is in the planning stages now.

    Elliot Zimmerman:
    Yep. Very good. Okay. Do we have another one, John?
    John Lyons:
    Yeah, we do. And here we go.
    Elliot Zimmerman:
    All right. So when are you planning your first trial to be run and executed on CTIS? This year, next year, 2024, or not sure yet?
    John Lyons:
    So folks are answering pretty rapidly. Let me give them a second. Still a few responses. So again, answers to all, but the majority is in 2022.
    Elliot Zimmerman:
    Very good.
    John Lyons:
    A few folks, aren't sure. A couple of responses said '23 and '24, but in 2022 is the majority.
    Elliot Zimmerman:
    That's great. That's good. And we would encourage everybody thinking in that same line to get prepared, because there is a learning process here and some process changes that we're about to get into. So that's a good segue into our next section, but to wrap up the first section of the webinar, just some key takeaways. Obviously the regulation and the CTIS is now live. If you haven't requested access yet, you can create a login on the EMA website, request access and permission. Chances are somebody in your organization may have already done that and they can assign you a role. Disclosure and transparency now being a very key part of the expectations of the regulation and the use of CTIS. We talked about the schedule and the three phases of rollout. And because of the impact on disclosure, as it relates to the end to end process, it is really the right time now to start working internally, if you haven't already, to align processes, roles, and responsibilities, communications, et cetera, to get prepared for that first trial. This is different and it's not just different for disclosure.

    It's different for every aspect of the clinical organization, regulatory, et cetera. So the change impact here is significant. So let's talk about how you can get prepared and what we'd recommend. So what are some key considerations for disclosure teams? The second section of our webinar is really around these four areas, I'm going to cover these before we move on. So the first one is think carefully about how the CTIS now involves disclosure as part of the end to end process. So remember I mentioned earlier, how with Health Canada, PRCI and Policy 70 regulatory submissions, it generally pulls in disclosure and transparency teams at the end after marketing authorization from a clinical perspective. But now you're involved throughout from the very start. And so you are leading into the second point here in the critical path.

    So things to be thinking about here are what is our process going to be? And how will we communicate internally to make sure that disclosure isn't going to be the hold up for submitting these documents? Remember a key point is public and non-public version documents need to be posted into CTIS at the same time, even if you're requesting deferral. They need to be submitted at the same time. That is a very, very key point to take away from this.

    So you must be planning how disclosure becomes an integral part of the process and how you're going to communicate and make sure that from a timing perspective, then you have the tools and the capacity and/or a partner that can help you with protecting personal information, commercial, confidential information in accordance with the schedule of all the document submissions. So we're helping. For example, quite a few of our customers think that process through and how we can be redact and anonymizing documents for them along the way, basically as an extension of their team. Or those organizations are using our technology to do that themselves in an expeditious manner. The third one being roles and responsibilities and consider your third party.

    So for example, CTS is brand new for everybody here. Some of the folks in the webinar today probably have gotten some hands on or they've gotten training. Others, maybe not. But there is training required that the EMA and DIA host. There are roles that you need to define. And there will be learnings from that. And if you're going to have a CRO involved in your study, you need to be thinking through, and ahead of time, around what role will they play? How will you grant them access, et cetera. So it goes sometimes beyond your immediate organization to third parties, that'll be needing to access CTIS. And then lastly is just how does this impact things from a global perspective? So if you're a study sponsor and you already have worked through disclosure projects with Health Canada. For example, you're disclosing information on clinicalstrials.gov.

    You need to be thinking through as well about what are the required and CTIS of what needs to be disclosed. And therefore you want to continue to be consistent across all your registries, all your disclosure projects, if you will, or submissions, to make sure that you're consistent and you're not masking something for one, like clinicaltrials.gov. But then disclosing in CTIS, that probably doesn't make a lot of sense, and you want to be consistent. So this is a nice table as a reference of some good things to be thinking about.

    We're going to move on to the third section of the webinar now, which is how do you prepare for that first trial. With consideration of the four points we just raised, how can you be planning ahead? So some learnings that we've had FROM working with our customers, number one is several of our customers have done a really effective job at organizing a cross-functional team to assess the impact of the regulation and CTIS. How does this change your business process? How does the disclosure team get involved? And when, and how will you coordinate the various activities for redaction and anonymization of these documents in a timely manner? What are the roles and responsibilities? Who's going to have access to CTIS? What roles will they have? As a side note. The EMA has a really nice document around personas and roles that I think would be really advantageous.

    And we're going to provide a link to that in subsequent slide. Number two would be initiating your first trial in the CTIS. I'm really happy to hear from the poll, many of you are already thinking down that line of getting a study this year, launched on CTIS. This is going to be really critical to do in a controlled fashion. Learn the system, prove out your assumptions, and of course, the training that you've receive.d and make tweaks, and document those tweaks, so that it's well defined. And therefore you'll feel more confident in a scalable approach for your future studies. Remember 2025, all of your active trials in Europe need to be transitioned to the CTIS. So while it sounds like a long time, that gives you about two years to really get the hang of us, make tweaks to your process, and also have a transition plan that you can execute no later than January 31st, 2025. Evaluating your current processes to make sure that you can support the anonymization requirements.

    So remember, these documents need to be posted in public and non-public form simultaneously, even when you're requesting a deferral. The public version still needs to be posted at that time. So having a quick turnaround for anonymization of these documents is going to be more critical than ever. This is our specialty at Real Life Sciences. This is something we can certainly help you with if you need it. Plan ahead now for that transition, which I already mentioned. And then lastly, there's some really good information the EMA is making available through their newsletter. Also, we're maintaining a page within our website of helpful resources. So when you get these slides from us, you can click this link and it'll bring you to a page where you can continue to view the most up to date information and learnings. Ahmed, why don't you talk to us for a minute about the impact and gap assessment that we're recommending.
    Ahmed Eldafrawy:
    Awesome. Thanks Elliot. Yeah. So really just to keep it quick here, the key objective here is, so Elliot kind of walk through some of the best practices, here we want to just take it a step closer, a step deeper, and really see what actionable items we can take. So when you do have to submit into CTIS, your organization feels comfortable and confident in that submission. And then the other thing is you want to make sure that you're also equipped with the right resources and technology as well, especially with those growing redaction demands that Elliot just mentioned. So the first one we have on the left is taking a look and performing a gap analysis. So what we really are implying here is you want to make sure first that your organization is aware and they are prepared of how to use, and they've been trained on the platform and they're aware of the regulation as well.

    So with that being said, taking those new regulations that you've learned and being able to understand how the software works, CTIS works, you want to perform a cross-functional gap analysis on your current process to define the areas where you feel like you must refine and implement new processes to meet those disclosure needs. Which takes us to the next one, process mapping. Speaking of those refined processes that we're implementing, the important thing here is going to be defining those rules and responsibilities of the users that are going to be uploading information, uploading documents into CTIS, but just as important, it's going to be the roles that are going to be working outside of CTIS because even those roles are going to be significant to those submission timelines within the system. It's also important for an organization to assess if it's going to need additional resources to help facilitate those growing reaction demands.

    And then lastly, for process mapping, your organization should probably try to perform a dry run to initiate a first trial. So to really truly assess what your organization's preparedness is and to see what actionable takeaways it can get out of it. Speaking of dry run, one of the most important things we truly recommend is for you to try to initiate a pilot trial. And try to initiate a pilot trial with a manageable scope. There is a lot of big changes here. You have new regulations, you have a new system, CTIS. So you want your first submission to not be a big one. If you have the opportunity to choose from multiple studies, try selecting a study with a limited number of states and a limited number of required documents, because obviously the key element here is we want you to focus on the emotions of going through CTIS and submitting in CTIS.

    So you can really focus on that and see what takeaways you can get out of that, in addition to the time you've spent and anything new that you've learned. Lastly here, it's important to also evaluate your process and your tools. As we mentioned multiple times there is a huge growing demand of document redaction, and these must be uploaded in a timely manner. So number one, one of the things you would want to ask yourself is are you working or aligning with a specific partner to help you meet those demands and timelines? If so, do you feel like your technology's equipped to meet those quick redaction? Being able to upload multiple documents at the same time and performing PPD and CCI redaction quickly and turning that out quickly. So really the key takeaway here is can your team and your technology handle the business need effectively and efficiently?
    Elliot Zimmerman:
    Great, thank you Ahmed.

    Yep. All right. And now to just zoom in a little bit more on how that initial pilot trial outcomes would be, I'm not going to go into each one of those specifically, but these are going to be some of the key takeaways that you really can get out of this. If I look for example, just right in the middle, assess at RFIs and what your effectiveness is in responding. These are going to be really some good quantifiable metrics for you and your organization to really assess how you did. Well, did we get a lot of redline version from the member states? How many RFIs did we get? And these are the type of things that are really going to help you when you get your first real submission and really be able to take all those actionable items from your pilot and incorporate them on your next trial that you'll roll out.

    Great. Thanks Ahmed. So I think we have one more quick poll. And then we'll get into some of our wrap up and questions. Yep. All right. So this one is around tools and services. So my organization has tools or a service provider to meet the increased redaction requirements for CTIS. So this is referring to the anonymization redaction preparation of the public facing documents, how well equipped and prepared is your organization today to support that?
    John Lyons:
    So we have responses coming in. Just give them a second. They're still coming in. And we have somewhat of an even distribution across yes, no, but not sure yet. Largest response there. I'm not sure yet.
    Elliot Zimmerman:
    Okay. Yep. And for those that are just getting started and starting to evaluate your process and how you're going to use CTIS, that's not a surprise. Because you need to be thinking through, of course, how those handoffs are going to work between regulatory clinical teams, disclosure teams, to facilitate the process of preparing those public facing documents. All right. Excellent. Thanks for the participation in the poll. I promised you a list of resources. These are some of the more helpful links and resources of information that we think would be good reference for all of you. Starting at the high level, the EMA makes the sponsor handbook available, which is really good overview of the CTIS, and getting familiar. So think of that almost as an introduction level. Easy reading.

    The training dates. And I see that there was a question. So I'll try to proactively address the question that was around training. There is various training that's offered. There's self-paced training, there's live training options that's facilitated by the DIA. There's also master classes of training. So if you want to use more like an internal train the trainer approach of having a master trainer internally, that then can train others, that's an option. And might be really useful for larger organizations. There is a link to a YouTube video on the high level functionality. So you can actually see the CTIS in action if you don't have access yet yourself. I did mention earlier the user personas. So as you start to think through mapping your processes and roles to users in CTIS, this user persona document will probably be helpful, at least as a starting point for you and your team.

    The deferral rules. This gets into a lot of the details. Ahmed shared the high level. There's a lot of details around disclosure deferral. So there's a specific link that we've provided there. And then there's another highlights. Actually then, I believe this one is the newsletter to keep track of the ongoing updates, milestones, lessons learned and things like that. This is their online, I think newsletter is the right term. So this is a sampling. I think as you get familiar with the EMA website, you'll find more, but this will be a good starting point for you. Again, ask John for the slides that way you can have these hyperlinks in your hands.

    Lastly, to wrap up with Real Life Sciences. So as you've heard me mention, we are a technology provider. We design and develop solutions specifically designed to help with anonymization of data sets and documents. So the CTIS fits squarely right in our sweet spot, in terms of ability to help support, redaction and anonymization of personal information, as well as commercially confidential information. We also offer outsource managed services. So those of you that maybe don't have the team or the staff to use a technology solution, we can provide that for you.

    We have dedicated resources to be able to support you through that. Think of that almost as we're an extension of your team to help with quick turnaround of these documents for public disclosure. And then lastly, the disclosure from a regulatory perspective, the disclosure world is getting more and more complex. We had initially EMA Policy 70, then Health Canada PRCI. Now we have Regulation 536 with the CTIS. There's a lot to be thinking about how you plan, how you strategize and how you execute in support of all these regulations. And that's not to mention any voluntary sharing initiatives that you have internally, so we can certainly support in that way also.

    So I think I addressed one already around the training. There was another one that I saw around deferrals. And the bottom line on deferrals is I think the question was along the lines of do we need to submit both documents if we're still requesting a deferral? The answers is yes. When you submit the documents for each type of document, you need to submit the public and non-public version simultaneously. Even in the case, when you're requesting a deferral. They both need to be submitted upfront, and at the same time. That's a key takeaway from this, because it really does drive a lot from a business process perspective and preparing of the documents. So that's indicated in the slides. I've mentioned it a few times. And I wanted to just reinforce that again, because it is so important. There's another question that I see around the response times. Ahmed, this might be a good one for you around how much time sponsors have to respond to, I think the EMA refers to it as a request for information, when the regulator or member state has a particular question.
    Ahmed Eldafrawy:
    Yep. Yep. So the sponsor is going to have to submit their responses within 12 days. And then to the member state. So sponsor submits their RFI, what the member state has requested. They have 12 days to do it. And then the member state has 19 days to respond back to the RFI, to the sponsor. So sponsor has 12 days. Member state gets 19 days to respond back to the sponsor.
    Elliot Zimmerman:
    Yep. Okay. I see another question from Jeff about are there any specifics known around the language of deferral requests and how exhaustive specific the EMA may be? I think it is a bit early, Jeff. I don't have any specific examples yet on this since it is still early days, but keep an eye on our website. As we learn more and gain more experience on this, we'll be happy to post something on there or contact you directly. I think I addressed on the training. Let's see if there's any other... There's a question here. Does the transition period apply to investigator brochures or should IBs, annual IB updates be submitted through the CTIS as of now? Yeah. When you're initiating a trial on CTIS, you want to keep that continuous and consistent using the CTIS for your IBs. Definitely. Yep.

    I think there's another one. Let's see. I'm going to keep scrolling here and try to address these as much as I can in the order that they came in. There's a question around how to get access to the CTIS. So believe the process is you need to first create an EMA website login. So when you go to the EMA website, I don't remember off the top of my exactly where it is, but you'll see the ability to create an account. So your whole process starts with creating an account. And then once you have an EMA account, you can select from almost like a list, of what kind of access to what EMA systems you're requesting access to. And CTIS will be one of those systems. You will need to indicate what company you work for, et cetera. And then your account gets provisioned after it's verified, is the way that works. Ahmed, question on how CTIS could work with other tools and systems.
    Ahmed Eldafrawy:
    Yep. Yep. So there are other databases that can work with CTIS. So yep. There are additional databases that can work with it.

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