Name: 4ward Thinking: Experts Take on V4 of the TMF Reference Model
Uploaded: 2025-06-10T17:06:05.883Z
Duration: 47 min 56 s
Description: 4ward Thinking: Experts Take on V4 of the TMF Reference Model

Transcript for "4ward Thinking: Experts Take on V4 of the TMF Reference Model": Hello, everybody, again. So this is the session for day two of TMSE three twenty five. So, we've had a a a lot of discussion already, this morning around standards, and we're gonna continue on that discussion with a a great panel, discussion today. Before we get started, I'd just like to do some some, housekeeping. So, Kim, I don't yep. Okay. So, this session will be recorded, and available at the end of the conference. So if you wanna share the insights, that you gained from today's, panel discussion with any of your colleagues, feel free to share the link. Anybody who's registered and attends a session of TMF week gets a certificate of attendance, and it's for the whole, for the whole week, not just for one session. We will, be answering questions. We'll be taking questions. So please, enter your questions in the q and a panel on on your screen. And if we see a question, this person, so this the discussion will bring it in. If not, we may we may address at the end of the session as well. And at the end of our panel's day, there will be a networking break. So head over to the lounge, if, you want to mingle or discuss with any of your colleagues around some of the themes and subjects that you've heard during today's panel discussion. So we'll start, our our panel, by introducing, our our panelists. So today's panel is being run by Donna Dorzynski, who is the, CEO of, just in time GCP and also, the leader of the, CDISC TMS reference model b four management team. So Donna plays a a key role in, in the v four initiative. We're also joined by Liz Farrell, from Agios. Liz is also a member of the triage committee, so he's also very involved, in, in b four, and Steph Fiscomi, from Apellis who, again, is is a triage committee member. So and then, of course, myself. So with that, I will pass it over to Donna, so that we can start to talk about, b four and and the impact of b four on reference one. Thanks, Paul. And thank you to everyone who joined us today and certainly to my esteemed panel, Paul, Steph, and Liz. I'm really excited to kinda get started with the discussion. Many of you who have attended are attending today might have had the opportunity to attend the CDISC meeting last week and hear a little bit about, what's ahead of us for v four. So I wanted to start today with kind of a just a generic question of what are the things that we can definitely expect to see as part of v four? We're almost six months in, and and I know we've got some real good decisions out there. So I'm just gonna turn it over to the group, and maybe we'll start with you, Liz. What are some things we're definitely Sure. So, a couple of those key decisions that it was very exciting, we were able to announce, in Geneva at the Cetus conference. But but really 1 one that's gonna be a bit of a change in vocabulary transition from the terms artifact and sub artifact to record group and record type. So no longer once we are in version four, will we be using the term artifact that will transition over to a record group. And similarly, instead of sub artifact, we will be focusing on record types. And a lot of this has to do with the fact that, you know, with the updated r three guidance, we there was a big transition from the word document and really artifact and sub artifact was so unique to the reference model anyway. We're really trying to standardize and align to the language and the vocabulary that's being used across the industry and embracing that term record. And it's just more equivalent to how we're dealing with data and documents and all of the things that compose the TMF. We're really looking at them as those records now. So that's a a paradigm shift, I think, that that a lot of people will have to get used to, but we certainly have runway and time to practice that in in our day to day efforts. So I encourage all of you to try to start using those terms to familiarize yourself with them. And then the other, decision, I guess, that we've we've made on v four is to have metadata standards and to implement some standardization and consistency on the metadata that we're using and applying and the formats that we're using and applying to all of the various record types in, in the the systems that we're using, but also just in our own terminology. We're embracing the controlled vocabularies of CDISC and and trying to ensure we're all speaking the same language, not just in intent, but in actual words. Really just embracing that standardization that CDISC helps us bring forward. So those are the two that I think are most useful or most exciting, I guess. Well, possibly, Paul, how about you? What what's what's exciting you about the decisions we've made so far? I'm a I'm a techie guy. Right? So I I like the techie stuff. But, I think one one decision that we made, which is very important, is, the decision around UID and numbering. So as you know, throughout each of the different versions of the reference model that we've had so far, we've had, the artifact number, which is typically a a six digit number. So it's grouped, two by two by two, for process and section and then artifact. So that's your, you know, zero one zero one zero one trial master pipeline. And and then we have you a three digit UID, which was a unique identifier that never changed and was always associated to an artifact. So even if we moved an artifact, say, from one process onto another, it would always retain that u unique identifier, that UID. And that was really important for for traceability, for migrations, and things like that. Now, obviously, we're moving to record types, and we're gonna have a lot more record types. You know, there's gonna be significant a significant number. And we've decided that we're no longer going to have the unique ID, so the three digit unique ID on the artifact or record group in the future. But we are going to to maintain a unique ID for the record types. And because there are there are so many potential record types, in the future, we're going to have a digit of, five digits instead of three. But the important thing to sort of keep in mind with this is that that unique identifier will never, will never change for a record type and will never be reissued even if we withdraw a record type. And that unique ID from a system standpoint, from a technology standpoint, will ensure traceability and will make it a lot easier for us to be able to migrate from one system to another or from one version of the of the reference model standard to another. So it's a really it's a really important piece of information. I'm not gonna go into too much detail, but we are defining conventions around that so that you can truly understand how to use it, how it works, how we come up with the numbers, etcetera, etcetera. The other thing that's important to keep in mind is we're not getting rid of that six digit, what we call system eval or RTPAK number. We're still keeping it, but it will be associated to the record group. So you'll still be able to refer to 010101 and and probably land in the same class. So that, I think, is is an important consideration as we start to get more granular. Awesome. Thanks, Paul. And, Steph, kind of thinking about the decisions, what is are you looking forward to? Well, I think I have the best news of all. And I'm hoping I'm gonna see a lot of emojis, a celebration, and some of the things I'm about to say. So hurrah. We get to keep the Excel spreadsheet for, our reference model. But high five. Very exciting. I think that's a little bit of you know, that's exciting because it still keeps the old and transition with the new and, you know, change is hard. And I think having that with, making that decision was a big deal. So really excited. I see a lot of that already starting to come through. So that's really exciting news. And I think the in the piece, really for me speaks to the effort that is going into this across our new industry. It is I mean, we have sneeze from sponsors and CROs and vendors and really culminating coming together and providing their feedback. And one of the biggest feedback that we have coming thus far as well is that we are keeping the trial country and site levels in there. So we're able to and that was something that came from our vendors. You know, that was ever an app. So I think it's really important that we maintain those as well. So excited for we have a lot going on. Awesome. These all sound like great changes. And as we think about, you know, the whole motivator behind v four was moving into this digital era. So one of the ways we've described the v four is kind of like moving forward to digital maturity. Right? And how does you Paul, this is really for you. How do you see aligning this with that broader digital transformation that's actually happening in clinical trials? Because it's not isolated to the TMF. It's really Yeah. A part of the industry. So, like, where where do you see this aligning, and where do you see the biggest opportunities to impact? Yeah. So so we're we're right now in right in the middle of this kind of transformation, when it comes to, clinical information and clinical records. We're we're about to see the birth of ICH m 11, which is the, the guidance and standard from ICH for digital protocol. And I think that that's the of many digital, record standards that we're going to see, in the future. And and so that, it just in itself, is very exciting because it means that all of a sudden, we can start to read a protocol that's in data format. So it has metadata fields. It has information that's digitized so that we can actually query it and understand it and then take action on that information. So all of a sudden, we're going to be able to look at the digital protocol and understand, okay. Well, how many how many different committees do I have and how many treatment arms are there? You know, is it is this randomized? And if so, how is it being randomized? And all these different factors that have an impact on the way that we, configure our trial master file and the way that we actually tell the story of the study. Now the digital protocol in ICHM 11 is being integrated into USDM, which is a standard that's been developed by CDISC called the Unified Study Definitions Model, which encapsulates all of the protocol information and then some. And this standard is being used by all of the other clinical systems to be able to read the protocol information, but also read other information about the study and eventually achieve interoperability between each of these different systems. And for us, this is really important because the TMF is very, very dependent on all of these other systems. They all contain TMF relevant information. And so if we can start to speak the same language of these systems by using the same standards like USDN, then all of a sudden, it's gonna be a lot easier for us to be able to interoperate with those systems and access information that's contained within those systems and understand that information because it's all codified using the same control terminology, and it's and it's organized in the same way. And so that that is really a it's a it's a key, differentiator for us because all of a sudden, we're no longer having to copy records and create PDFs and then upload them or or create these placeholders and then try and scramble and find the record in the relevant system, all of a sudden, things start to get connected. And so this is something that I think we've been waiting for for a very long time as an industry, and it seems like it's finally coming to fruition, which I think is a game changer. And then I think finally, the digital protocol, as I said, is is super important because all of a sudden, we're also gonna be able to start to navigate our TMF by digital protocol. So we we're gonna be able to start creating associations between our record types that we formalize in version four and the different sections and subsection and and areas of the digital protocol. So if I'm looking at the digital protocol and I'm looking at the randomization section, all of a sudden, I'm gonna be able to start to see records that relate to randomization because we've made that connection. So that's also an important an important aspect of this. And then one last aspect, and you can see that there there are lots of different aspects, is the information that's contained within the digital protocol, and other systems will enable us to improve our completeness, because we can act on the information that we're receiving in this very sort of structured way to, predict which records we we should expect to see within our trial master plan. So in the future, hopefully, the days of trying to compile your expected document list and and and trying to keep that up to date and sort of trying to work out what, you know, what's going on in the study, hopefully, those those days will be behind us and we'll actually have, our expected record list being generated automatically based on events that are occurring on in the study or based on study design parameters that are contained within the the digital protocol. So I think that's the future. That's what's that's what's in front of us, and that's why it's so important that the TMF reference model becomes a a digital TMF standard to be able to be part of that bigger picture. That was a long There's a long answer to a short question, Marpal. I thought I had the corner on that. I know they're really helpful, and I think I've heard you answer that question a 100 times. But I liked how you connected, m 11 so deeply to the DM app. You know, we're now part of c desk as a reference model. And so it's really important to think about the impact of v four that we align with that data driven world. Right? But so many people on the on the call today or on the on the webinar today are also thinking about, well, how does that impact my processes? Because as an industry, we tend to be a little bit more process driven. So we know that one of the goals of v four is to create a more module modular and process oriented approach. So as we think about it in terms of record groups and record types, which Liz told us about at the very beginning, How do you think and I'll just direct this Liz, to start with. How do you think this is going to impact how organizations actually think about TMF oversight and owning the TMF? Because it's kind of almost like a full circle story now. Exactly. It it I think what we're going to see and I I can't predict the future, so I I don't wanna promise anything prematurely or say, you know, anything about exactly what what we will end up with. But I think the concept of moving towards those record groups is going to help us align the processes that we are conducting under the protocol, under the parameters of the protocol to where we find the types of records we're looking for. So we keep that idea of structure of navigability that we've all become very used to and comfortable with while helping us create, a more aligned, I I guess, way of thinking of how we're executing our processes and the output of those processes. I think right now what we have noticed is is as we've been reviewing the current version, is that we are a little inconsistent with how we use artifacts. Sometimes it is just a very specific single what now will be a record type. In another case, it's just a very broad description of the type of content that you could find there. So I think us moving into leveraging these terms and helping us align more to what those processes are will maintain that familiarity. It will it will help us continue to use the reference model in a way that we can sustain and we don't have to completely break the chains of of how we're used to working. But it will help us look at the processes in a more, in a way that is more descriptive of the execution of what we're doing and the associated output. I don't know if anyone else has anything to add there, but that's my my take on it. Steph, I don't know if you have anything you wanna add. You know, I no. Not much. We've said that wonderfully. And, I mean, wholeheartedly, I have the word just kind of you know, my notes of prior to discussing this panel is a lot of it is alignment. And it it really telling the story of the TMF has been the name of our game since day one. And versus being more of I mean, we built our niche presence industry with a lot of great efforts and and some of them patchwork and some of them involvement, but this will bring it all together. And I think in a better way, an easier way tells for it of our TMS, tells story of that study going back to that digital protocol. So alignment is key and, and it's not just a little alignment here and a little alignment there. This is going to be an overhaul of alignment across everything to make that data flow. Those record together tell that beautiful story. Yeah. I think just to kinda summarize it altogether, the goal of v four is to be transformational, but try not to lose the things that we really rely on to do our job. Right? So we've moved from record type to and, we've moved from artifact and subartifact to record group and record type. We're including the record types, which used to be the subartefacts as part of the standard. We're trying to incorporate all the needs of the m 11. We do really, I think a great question come in. So I'm gonna read the question, and then you all can decide who wants to go But the question that came in was, is before designed to be more adaptable to future regulatory shifts, decentralized trials, real world data integrating? So who wants to start? I mean, I I'm happy to to start. So so, yes, absolutely. One of one of our one of our sort of objectives as a as a a a group is to to be very much comprehensive around various different types of trials and studies, and and ensure that we're able to encapsulate everything. And so our goal is to to bring in sort of, you know, obviously, the ISF, the real world evidence or noninterventional study, ancillary models, as well as, do do more work on the, on the medical device side of things as well so that we can also cover those completely. And so our our goal is really to incorporate everything. We haven't yet put in place a group around decentralized clinical trials, but it's it's funny you mentioned it because it it's already come up once this week and last week as well. And so I'm thinking that more and more, we're probably gonna have to start to think about putting a a working group on that as well. But the goal is definitely to to be very comprehensive, but also to have a a very integrated model because, obviously, all of these different trial types have commonalities. And and, of course, there's a lot of commonality as well with the ISF and the sponsored TMF. So we do need to make sure that they're they're properly integrated. Yeah. I think you make a a good point, Paul, and that one of our goals with v four is to really, broaden our reach and and kind of bring everything together into one central standard, before reference model. And so as a result, we've actually thought about all the different regulations that have become, active recently. I see 86 r three. We have an actual working group around that. We have a working group around eDCTR, and all of that comes out of the triage committee. So the triage committee is a group of industry that is kind of, just like it sounds. That's where all of the recommendations for change or even the ideas come out. They go to the triage committee. And, Liz and Steph, you both sit on the triage committee. So I was wondering if you could speak to if the two of you could actually speak to what are some of the challenges that you guys are actually talking about at these meetings. Right? You meet weekly. You know, the people that are involved are really dedicating a lot of time and energy to trying to represent what industry is looking for and what we need as we have this vision for, you know, the future. But what are some of the things that you've been talking about and that you're working to have before address? I'll start off. So I think one of the main challenges, I think, it it's even representative in the type of feedback that we've gotten. It can range from something very very specific and oriented to us, a unique sub artifact or a unique piece of the reference model all the way to something fundamentally different about the the structure of the index altogether. So I think the one main challenge that I see we're trying to tackle is how to how to tighten up the areas of the reference model that currently leave a lot of interpretation or opportunity for interpretation or various types of use. A really good example is even around CDs where that seems like a very straightforward type of document, but or record. Excuse me. I put it in my swear jar. Whether you're coming from a sponsor or a CRO side, very often there's a huge amount of discord between whether you're using zone one, the the CV area in Zone 1 versus Zone 9, and it can just be a difference based on perspective. Neither organization or either perspective is wrong. It's just that's how you would interpret it based on the framework and framing of how you're, using and looking at the reference model. So I think one of the the big challenge areas that we're trying to address and hoping we can, you know, really make some fundamental differences is in those areas where there's opportunity for difference of perspective, difference of use, difference of opinion. And and by cleaning those areas up, we'll be able to enhance that interoperability. We'll be able to enhance all of those things that we're trying to achieve here by not having variability organization to organization in how we're labeling things, using them, naming them, you know, where we're putting them in in the overall structure. I think a lot of these spaces we're we're stumbling upon. It's like there's six different right answers. None of them are wrong. We could we could really make a decision to put any the the final place, any one of these areas. But what we're trying to do is say this is the right one and give enough instruction and give enough context behind why it should go here. Hopefully, it makes sense to the majority of folks. I I don't think every decision is gonna be everyone's favorite decision. But at the end of the day, if we're all using the same definition, the same structure, the same standard, it's going to be in the long run a much better model for us to use. Steph, thoughts on this as well. Yeah. Absolutely. I I'm over here smiling because it kinda struck me a little bit. Liz pointed out maybe part I was part of the discussion yesterday, and it was so interesting hearing the different perspectives. So it is great to hear it, but it's also very challenging to navigate through because you have people coming from all sizes of companies, all different types of companies. It's an amazing team. It it truly is. And, and people very, very passionate team of people, which we all are, but someone may not align with the other one. And just try to say, not who the better as Liz said, but what is the most expected and I think, Liz, you mentioned this earlier. We are still two years out. We don't know what the future still gotta hold in two years and beyond. So what are we talking about today that will apply then as well? So there are many different things. I mean, Liz, you talked about CV. I think we also talked about plans. If, you know, plans on one section, all in one section, do we apply that a different, you know, today, different levels for different so it was just what can a system do? What can a not do? There are so many and it just stems from one little question. I believe we have, like, a thirty, forty five minute conversation. But to tear it apart so much, I think it's so value such a valuable effort that enables us to say, okay. We really did our research. And I think a big part of that, and also going back to what Liz stated earlier, is some of the feedback that's coming through from folks that aren't seeing the prelaunch community, just from our everyday users, distributors, part of our team up space, whatever it may be, has been also very interesting as part of an organization because I I mean, do you understand what they're saying? And in some words, I guess, I do. Let me walk you through. So I guess there's always, for us, some educational opportunities as well. I'm very excited. Their talent is in there. Our definite benefit of being part of this committee. So I I thought it's two things. I'm sure you're thinking the same thing, Paul. You guys spent, thirty minutes to forty five minutes talking about CDs yesterday. Paul and Lisa and Jill and I probably spent an hour talking about that very same thing before it came to you. I think the takeaway from that is a whole lot of thought is going into this because I think we understand the responsibility of creating something that we're looking to have industry adopt as standard. Right? What does it mean to be a standard? And I I think there's a great question here that came in at 12/21, so just helping Kim throw that up on the state on the the screen as she would. But it's about standardization. And so when we become a standard, we're actually, you know, kind of putting altogether everything that everybody said so far. We're looking to move into a digital era. And so in order to move information from one organization to another, we, we need to create standards. And so this question, I thought, was a great question, and and Paul, I'll ask you to take it. With formalization of sub artifacts in the record types in d four, will companies still have the ability to customize based on business needs? And and the the short answer is yes. Absolutely. So even though, you know, the the the the reference model is becoming a formal standard and sub artifacts to be known as record types will be formalized. We will be issuing, a an implementation guide, which will explain to you how you can go about creating your own custom record types, because we realized that, you know, there may be very, very specific study designs that are just not covered by the the list of record types that we've identified as a group. And so we will, be giving you the the the sort of the the tools, if you like, to be able to create your own record types, and those record types will be identified by a specific unique identifier beginning with nine. So if if we see that there's a record type that has a UID beginning with nine, we know straight away that that's a custom record type. It's we're not gonna find it in the, the reference model, but it will be formulated in such a way that it's consistent now if we start to see a record type that is systematically showing up as a custom across the board, then we'll probably start to integrate it into the model itself. You know? I think that with everything that we're doing in terms of the structure and the organization and the tools that we're gonna be putting in place, and the and the, you know, the the the the conventions that we're defining as well, we will be able to expand the reference model quite significantly from what it is today. So over time, I would expect the record types to grow, the number of record types to grow. And, Paul, to add on to that, I think you alluded to it earlier as well. Part of what we're doing on the triage committee is looking at what record types do we already know we're missing from there. So we know we're in a place of deficit at the moment in in terms of our model. So we certainly will see an expansion of record types and and really, again, some clarification of the ones that are ambiguous, but we'll be adding on to that. So we're hoping, you know, we we can't anticipate everything as Paul said, unique study designs or even new regulation that we can't anticipate today that will come along may force us to create new record types that don't exist today. But we are doing our best to make sure that we are bringing in those missing pieces that exist in the model today to add those into the model. So, hopefully, each organization will at least start from a place of needing very little additional customization. Yeah. Absolutely. That's certainly the goal. We had a an a question come in. I'm gonna ask my question that I have about, like, how we can start to prepare, and then I'm gonna throw this other question up because I think it's a nice follow on to it. So with the targeted release of, for some time first quarter twenty twenty seven, what can organizations start to do now to prepare to this cut this pretty big shift that we're expecting to see with c four. So I don't know who wants to start. I'd love to start. Good. I mean, we're here today. Right? Attend as many sessions as you can. Ask the question. Even if you think it's already been answered, if you think it's silly, ask the question. Because, one, it'll help you prepare, and, two, it'll help us know what we need to be educating as a committee, as an organization, out to get you all ready. Secondarily, and I think, Liz, you said it earlier. You said documents, you could leave with the records, put it in the square jar, documents in the square jar. Just your mentality of how you speak as we're changing over some of these terminologies and how their organization start to shift too. I know I've already started to do it within mine a little bit, and I trust me, I do it myself. I said documents earlier today. I'm like, record. I mean, record. And I mean, it's ingrained enough. Right? And, it's ingrained in someone who's been around for many, many years doing this. But, once we start building that shift and educating ourselves and then being train the trainer, Attend these sessions to be a train the trainer and then train your company little by little. And maybe it's your team, maybe it's your stakeholders, as we transition. And I think if you continuously to do that, once we get out two years out, it will be a lot smoother. And as we go as we grow into this, we're just gonna be educating you all what we're coming up with so quite easy. I think I I sorry, Liz. Yeah. I'll I'll be a gentleman. Ladies Oh, I was just gonna say I couldn't propose Steph's, Steph's answer more, but certainly reinforcing the the presence at as many different forums as you can can be at. I know it's difficult sometimes to be able to attend conferences or all of the conferences, but finding within your network, sharing the information that you find even if you can't personally attend and bringing that back to your organization. Being that champion for these changes within your company allows you to kinda have to minimize your footprint. Definitely financially for your organization if you can't always navigate getting budget to to attend everything, but finding the ones that are free, which is always great and being able to participate. But also, you taking whatever learnings you can get and finding where those learnings and those materials are available to bring whatever information is coming down the pike, you know, in in as real time as possible. I think we mentioned before, we're just we're still in the midst of so many decisions for what b four will bring us. So the information is gonna be trickle out constantly, and there's going to be new updates that we're going to do our best as a commune you know, a steering committee, as a triage committee to communicate out to you all, but you've gotta take that and bring it to your organization and champion it. Yeah. Yeah. I'd I'd like to add that the other thing I think you should also be doing is is, speaking with your vendors. Now the vendors are an important part of this, and there is a sub team that was that was put together and was very active with pretty much all of the main vendors involved and represented. And there's lots of active dialogue going on among the vendors and also with the vendors and the SME group. So so they are definitely aware, and they're also, I think, excited to start working on these concepts. And I think it's important that you you talk to them about what they're planning, so that you can kind of get a clear picture in your mind. And then I think the other thing as we get a little bit further down the road is start to think about what's your what's your implementation plan? What's your migration plan? Yeah. How do I get to this? What are the kinds of things I'm gonna need to do? And then also, you know, what's my what's my policy? You know? Am I going to apply this to just new studies moving forward? Am I gonna have a a pilot study? Have a plan. Start to work on your plan. And then as as we, as as as a community start to make decisions, and communicate those decisions and as things evolve and, you know, there's gonna be a lot of communication, you can start to adjust your plan. So by the time you get towards, you know, mid twenty twenty six, you've got a pretty clear idea as to how you're gonna move forward with this thing, and so does your organization and your teams. That's one thing I would recommend. That's a new market. Got it. Number one, become a volunteer. You'll get a lot of information. It depends it depends the general yeah. It depends the, the reference model, our general meetings that happen. There's a lot of information there. And last but not least, ping anybody on LinkedIn. Ping any of us. I we love answering questions. We I mean, I obviously feel a lot like that. But ask us. We're always happy to ask. I I definitely know I have reached out in my TMF world. And, if I needed some some guidance or at least some validation on something, we're happy to help. Yeah. For sure, Steph. We have a question that came into 12/22 that I just kinda it's a nice tag on question. And I think it's a it's a question worth just addressing. And it's my my company e t m s structure is based on TMF reference model version three. What do you see as the biggest challenges with implementing the reference model v four with the number of ongoing trials being managed in the system? So I think this is a great question. This is kinda like a follow on to what you said, Paul. Begin thinking about this. But going from three is pretty different to you know, your there's several changes that happened along the way. Yeah. So what are just a separate tool further than, you know? But my immediate thought is you need to kind of weigh up, like, cost benefit. If you if you have a study that's running on version three and you're getting pretty close to the end of that study, is it worth migrating it? Maybe if it's sort of a pivotal study or a study that's gonna be used later on for an inspection or for to support a marketing application, possibly. But I think you need to you need to kinda do that that that that that that cost benefit analysis and sort of come up with some criteria as to when you would migrate versus when you wouldn't. And then the other thing is is, you know, obviously, you need to speak to your vendor who's providing the ETO solution and ask them, well, how's it gonna work? You know, can can I have sort of two different versions that cohabit, together? Or do I have to move everything in your in your vision? So that's why you should be having dialogue with them now to sort of understand what their game plan is as well so that you can work that into your strategy. Awesome. I think those are helpful helpful tips. And I think it's kind of a nice lead in to, another question I have is, what role should change management and training play in ensuring successful transition to the new model? I think it's it's an industry responsibility. It's an organizational responsibility, but could each of you just, speak briefly on that? Do you wanna start, Steph? Yeah. Love to. It plays a huge role. And right now, we are in the middle of change management. Right? We are here talking about it. And I and then I think we've already gone through a little bit, a few months back of getting stakeholder feedback. So that's part of change management. We wanna hear from you, and I'm gonna tell you right now, even though that was a few months back, if you have feedback, keep sending it in. It is so vitally important. So it's it's a huge it's we're part of it. We're moving on. You know, the change management piece throughout our organizations and our industry alone aligning those together. It takes time. It takes education, and it it takes us, as individuals and leaders and contributors even to roll this out little by little. And then at the end, having that that big push, which will take a little bit of time, but I, I think my dad will be very well versed in all this this information that's coming out. Mhmm. Yeah. Appreciate it. I think no matter what the the change that we're going to introduce as part of this, it it's going to impact all parts of your organization. So you very well may sit in a TMF specific type role or a clinical operations role and and it might all the changes that we'll roll out might make a lot of sense to you and you might be able to digest those materials. But again, I think there there's going to be a huge impact in how other functions that might only touch the TMF, a a smaller volume amount, I I guess, or may just be a little more resistant to wanting to learn more or wanting to have to understand some a new concept. So understanding and once once we've rolled those changes out and once you have even the the trickles of information for areas that we're going to see differences in, reaching out to those parts of your organization that you think might be a little more challenged to understand the why behind the change, to understand the how it impacts me behind the change, and even just making them aware that it's coming because they might not be as tuned in to some of the forums that that we're all used to. I I think that's a piece that you can start doing in your organization. Now answering a little bit, Donna, the question you were asking before, but also that will really make the transition to success and and the implementation once it comes to success within your organization. Because if you're starting from a place of complete ignorance of the change on day one, you're gonna have a much higher hill decline now that you're trying to implement materials. So so laying that groundwork now is just that initial part of your change management that I think is gonna be worth it's waiting gold. Exactly. Paul, thoughts on this? Yeah. I've I've been sort of sitting and listening to to what Steph and Liz are saying. Totally totally on board. There's a couple of things that sort of strike me. I think what you mentioned is, you know, there can be different levels of understanding across the organization and and different needs of understanding. Right? I mean, not everybody needs to understand every single detail. Like, you know, UIDs, for example, and I'm sure that, you know, there are some folks in regulatory who don't really care that much. You know? But but how, you know, we're organizing their their record types, they probably do. What I think we should be thinking about as as a reference model is how can we provide support to the industry through things like train the trainer, for example. I think that, you know, we can provide training, of course, but I think it's always good to have training given in the context of your organization. So if we can train trainers within each organization and they can then adapt that training and then provide training locally, to to their various different stakeholders that makes maybe more sense for their organization. And I'm also thinking around change management. Maybe we need to have things like a kinda like a change management toolkit where we can provide materials, to organizations that, again, they can adapt, so that they can get that message across and and kind of support them in in their change journey and their sort of onboarding, journey, rather than trying to sort of train everybody. I think that's what we should be thinking. I'm sorry, Paul. That's that's it. I was just gonna say c desk. We're looking at we have always some okay who is on our program commit team and is also on the training team along with Diane Nicko. And really thinking about this community, we get we will begin to start rolling out just some training around this. We're not going to wait until before. As we are making decisions and coming up with a group of, okay, this is ready for for companies to start to implement. And I think one thing you can start doing pretty soon, as soon as possible, start thinking about record groups and record types. And just kinda switching when you're talking about an artifact, talk about a record group. And when you're talking about a subartifact, talk about a record type. Well, the names may change. The spirit won't change. And so I think that you're safe to just starting within your community to start to use those words. I know we only have a couple of minutes left. A quick question came in that I wanna address, and that's, like, what's the plan for making this a standard and talking to the regulators? And I think, Paul, I know you've been having a lot of conversations with the regulators. I'm starting to. Paul, can you just talk briefly about the goal here with that? Yeah. So so we obviously, one of our objectives is to gain recognition from the regulators as being the standard to be used to organize TMF content for clinical trials. So that's that's really part of our, key objectives. And so we've we've, already started to reach out and speak to different inspectors. We're also leveraging, our, our our states as being part of CDISC to open doors for us. So for example, we've been invited to, ENA, IWG IWG group in Amsterdam, in, November, I believe it is, to discuss essential records, for example, as as part of CDISC. And so we're we're starting to get a seat at the table, and that's really important because for us, the regulators have always been interested in what we do, but we've never ever been really endorsed. And I think that if we could if if we can get that that endorsement, it's gonna change things significantly, and and it's gonna be so much more clear cut. So I think we're working hard on this, and I think being policy, this can be coming as formal standard our key, to to having those dialogues as as, you know, the inspectors and the regulatory, agencies really are key stakeholders. I mean, they're the consumers of what we're producing. Right? Or one of the consumers anyway. And so it is important that we have that dialogue and and so we're getting there. Awesome. Thanks, Paul. So we have a it looks like we have a minute left. So I'll just do a quick round robin here. When you think about b four, what's what's maybe one or two words that come to your mind about, what before is going to make better for the future? So, Paul's always good at thinking honesty. So, Paul, what what are one or two words that you might think about that, that that that you think about with before? Better story. Nice. I like it. Now by you, Steph. I think inspection steady and ready. Nice. And there Liz? I I would just go with less questions, more answers. I think a team effort. It's really been a team effort. It's been amazing how many different people from how many different organizations have come together, to really embrace this effort. So I just wanna say thank you to everybody who joined us. Thank you to you guys. It was fun working on this. It's always fun interacting and talking about our greatest passion, right, trial master files. So thank you. Yeah. Thank you. Thank you, Donna. That that was amazing. And it it's up to me now to sort of end the session. But before I do that, I do need to speak about the, the next session, and that's going to be tomorrow morning, or tomorrow afternoon for those of you in Europe, where we'll have, Joanne Malia from Regeneron who will be giving us the lowdown on ICH e six l three, and what it means for the the TMF landscape. So I think it's gonna be a very interesting talk. Lots of, very good information that please take away in that talk as well. So do please join that session. And with that, I believe it's now time for you to head to the lounge for the networking break, the last networking break of the day, and maybe have your lunch, you know, with with your colleagues, in that virtual lounge. So, Liz, Steph, Donna, thank you for an amazing session. I always, love having these discussions because there's so much, exciting stuff going on, and really looking forward to, to our journey moving forward. So thank you everybody, and have a good rest of the day. Thank you, Paul. Thank you.