The TMF Standard Model V1 is the next-generation framework for managing the “trial master file” (TMF)—the complete, inspectable record of a clinical trial. Developed and published in October 2025 by CDISC, this release marks a transformation from the former TMF Reference Model into a full-fledged standard.
The TMF Standard Model V1 provides a scalable, interoperable, future-ready structure: now aligned with modern regulatory expectations and built for automation, analytics and multi-system exchange.
Join us for this live webinar where we will cover:
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The key changes introduced by the TMF Standard Model V1 – what’s new, what’s different, and why those changes matter for your operations.
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The “why” behind the evolution – how this new model supports inspection readiness, regulatory alignment (e.g., ICH E6(R3), EU Regulation 536/2014), and digital/automation enablement.
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Actionable steps your clinical operations team can take today – for example: assessing your current TMF structure and metadata practices, aligning with the new record‐type hierarchy, starting conversations with your CROs/vendors on transition planning, and building readiness for multi-repository and digital exchange.
View the full session or read the transcript below!
Full Transcript
Kevin Tate: Welcome everyone. Thank you for joining us for the unpacking the TMF Standard Model V1 webinar. We're excited you're here and this is a topic we're really excited to talk about.
First, a bit of housekeeping. As usual, we'll be recording the webinar and we'll send out a link to the recording. If you miss the webinar live and you're watching the recording later, hello future people. I hope you enjoy it.
This is a topic that's really, near and dear to Kivo. We do a ton of TMF work and we're looking at the introduction of the standard model from a lot of different directions. So I just wanted to tee that up; why we're so interested in what's happening with the evolution of the standard model.
Sarah, you wanna move to the next one? There we go.
We're talking about this 'cause we do a lot of work in the TMF, and that takes a few different forms. For context, these are the different lenses through which we're looking at the evolution of the standard model. Oftentimes our sponsor clients will store their active internal trial docs in our TMF. So we will be working with sponsors who are working with a CRO, but they're storing documents on their side, typically the central trial docs, protocol, IB, et cetera. They'll be looking to sync that up with the CRO or migrate that over at the end. So that's one way that we're often setting up TMF cabinets and talking about what standards to use and how to merge them.
We also have an increasing number of sponsor teams who are managing their own trials and their own TMFs using Kivo. I'm careful not to characterize Kivo as a full CTMS. We don't do patient billing and scheduling and those things, but many teams are finding they like Kivo's TMF+ if you will, for these smaller studies. So we're getting into more and more active studies on that side.
Another way that TMFs intersect with Kivo is with our CRO clients. We have an increasing number of CROs that we work with. They tend to manage the client study TMFs as well as their client study activities in Kivo and I think one of the things we've enjoyed learning from them is that the way Kivo is priced and packaged, tends to be particularly well suited for CRO teams and their clients. That's been a rapidly accelerating part of our business.
Finally - and then this is probably what happens in the largest volume - is sponsor teams will use Kivo to migrate their completed study TMFs from CRO systems or, yes, sometimes a thumb drive in somebody's desk, to Kivo for safekeeping and archiving. We're starting to do 5, 10, 15, 20 of these a customer sometimes. So all that gets us thinking a lot about the format and structure of those TMFs and how that is evolving.
To the last bullet, we're actually a participant in the CDISC council. I think there's one more on here, Sarah, on the build, where we get to have some input on what this V1 model is.
Sarah, I think you were actually in a meeting this morning about this? We're excited to discuss it, and provide feedback from our community. So thank you for being a part of that. And we'll share what we've learned so far and our perspective.
And I'm delighted, introducing Sarah, to have Sarah with us. Sarah is Kivo's director of Clinical Market Strategy. She works with all of our clinical operations customers. Her academic focus was on biomedical sciences and behavioral and social sciences. She's spent 13 years working in CROs, sponsor level, and site level studies, so really knows how this happens in practice and in particular, and we're lucky to have her Kivo focused on this, has been really focused on clinical trial technology solutions and how software and processes fit together around trials for the last several years. Delighted to have Sarah be a part of the CDISC's work and to be sharing some of that with us today. So with that, take it away, Sarah.
Sarah Ruiz: Thanks, KT. I'm very grateful and fortunate to have the user and administrator experience on the tech side for most of these platforms. It's awesome to see everything grow the way it has.
Let's get right into it. We - meaning the industry - are transitioning to a standard model. What does that mean? The data standard hosted by CDISC means that there's gonna be a lot of controlled terminology. It's gonna be one standard way of doing things. We'll get into what that actually means, but why are we going from V3.3.1 to standard model V1?
The meeting I was in this morning was actually a general webinar to the public. So highly recommend going and watching that when the recording comes out. If you didn't just come from it like I did, starting over just makes the most sense. There's so many changes to this new model. Change can be anxiety inducing, but I think this is a very good thing for the industry.
And the analogy used this morning is we're basically rebuilding a house. We have to start with a new foundation. What are we expecting with the change? There's gonna be a lot of updates. There's a specific committee in the CDISC team for every single zone of the TMF, so we're gonna see a lot of updated standardized fields, some more controlled terminology. There very possibly is gonna be new zones and sections to fit the technology evolution in clinical trials.
A very important thing that we're moving towards is machine readable TMFs. Think about how CDISC owns CDASH and STDM and ADaM and how important those data sets are to your clinical trial submission. Documentation record keeping is just as important at this point, to tell the story of your trial when you're submitting to a regulatory body. This is gonna be very important, for getting through your information quickly and having decisions.
And possibly the most important is risk proportionate oversight in line with the new revision three of ICH E6. CDISC is providing a framework of what's needed, and you'll be able to say, "this applies to my organization, this applies to this therapeutic area, this applies to my existing processes". Or maybe, "oh, I don't have a process that outlines this new standard model. I probably should write one."
What are those key changes? We are no longer using the term artifacts or sub-artifacts. Those are being replaced with record group and record type.
I'm gonna get into these key changes in future slides, so I'm sure you have lots of questions. Hopefully I can answer them. If not, there'll be a Q&A afterwards.
In addition to that, there will be a unique numerical ID that maps to the record type. Now, as a tech person, as a data person, it's very easy to confuse this with an EUID, like a system generated unique id. That's not the case here. This is very specifically mapping to the record type. So you could have a unique ID in this trial and in this trial it's mapping to the record type. There are a lot of benefits to that that I'll get to.
This also will add considerations for how we handle and file translated documents, computer system validation documents. Think things that aren't IRT or EDC that you're still using. E-consent, ePRO, eCOA, things that need to be validated, that have very clear documentation and not a great place to file in the current structure of the reference model. Those will all have a place to go.
And then very important , because we work with different people all the time, uniformity in the metadata. Controlled terminology. There's not a lot of risk in miscommunication when you uniform the terminology that you're using to talk about very important things in your study.
Speaking of those key changes, going from artifacts to groups, going from sub artifacts to types. This is a huge shift in scale. This is directly ripped from the CDISC webinar, so you probably recognize this from the Nashville conference. There are currently three levels with 250 artifacts in each level, 515 sub-artifacts that you could create your own custom or pick and choose. They're "recommended," right?
Now we're going from three levels to four levels. So you're still gonna have some zones and sections, but now you're gonna have groups and types. There's over 2000 record types currently. They were very clear and open about... this is just V1. There are obviously gonna be revisions to V1 as we grow, adopt, learn new things that you can only learn from applying a new model.
I think this is probably a little anxiety inducing, like, " how do I manage 2000 record types?" I am very happy about this personally, because if you think about, "all right, I have five sites on a single trial study." This already blows up the reference model. I don't know whether to file this at the artifact level or the sub-artifact level. There's only gonna be one place to file it. It's just gonna be a record type. Record groups gives you an additional layer of organization that I'm hoping makes things move a lot faster. You're not getting all of your essential documents from an investigator and filing it in 30 different places.
So what's my take here? It removes any ambiguity on where you're supposed to be filing your records. Keeps that consistent. Sets better expectations from what is expected from your TMF at the study start, a lot easier to create and maintain a TMF index, in my opinion. And it alleviates a lot of burden of your typical standardized file naming conventions because you'll have a unique record ID to identify and search for those records.
Kevin Tate: Question on this one. And by the way, please jump in with questions, We'll be monitoring those and as Sarah said, we'll have some time at the end. So please don't be shy with the questions. And I won't be shy in asking. Yeah, 2000 record types seems like a lot and potentially a lot of figuring out. I know when we're working with customers using the 3.3.2 model, we'll talk about placeholders and if they want to use them, what are all the expected documents and making choices about what artifacts and sub artifacts they do and don't expect. Do you anticipate a similar landscape, although with different record type names, where there'll be expected best practice or exceptions? How different will this really be?
Sarah Ruiz: I expect the same conversation with easier decision making, if that makes sense. I think this is a standard, but it doesn't mean every record type within the standard is applicable to your study. There's going to be record types that deal with real world evidence. There's going to be record types that deal with device studies and that might not be applicable to your therapeutic area or the phase of your study.
You are going to dictate what is required for your study. There's still going to be that core documentation, but CDISC is calling it the sphere of considerations. Start with your core documentations and then slowly zoom out as you build your study. Since it is CDISC, I like to relate this to how you build your EDC.
You're gonna need to track your vitals. You're gonna need to track your therapeutic area, but you don't need a visual acuity exam on a gastroenterology study, for example. So it's going to be a lot more clear on what applies to your particular trial.
Kevin Tate: It makes a ton of sense and I do love a good visual acuity joke.
Sarah Ruiz: We love our laugh though, vendors.
Metadata revamp. We, like Kevin said, are very fortunate to be involved in the vendor committee with CDISC to get a head start on what makes sense as tech vendors in this clinical space.
This uniformity in terminology means we're going to have a consistent use of trial, not study, right? You'll see metadata that classifies and identifies your records and those metadata fields will always have the identifier word. So record identifier, trial identifier, protocol number and things like that. There will be a single- and I'm giving myself credit for this decision, so if you don't like it, don't tell me- but there will be a single record for your document date with a defining date convention. So when it comes to Kivo, that's gonna make your date reports a lot simpler because you can say, this is my document date. The date convention might be signature date, expiration date, approval date or version date. So this really enables clean reporting for all of your documentation within the TMF. You don't have to pick and choose which date is relevant or important. It doesn't change a lot from 3.3.1 to V1. It just changes how you organize it.
There will also be an additional expiration date for applicable documents. That's not gonna apply to everything, but you will have that one additional date to denote when things are actually expired.
A very important thing is a clear definition on what metadata is required and what metadata is recommended. Right now it's very, pick and choose on how you wanna organize your metadata and how you wanna unfold at this point. Again, making those decisions easier 'cause they're not on your plate anymore.
Kevin Tate: That expiration date is gonna be interesting. We get that question a fair bit, but also as soon as you have an expiration date, then "okay, but then when's the effective date and when's the renew date?" And how do we manage that? It'd be interesting to see if there's some process management around that.
A couple of great questions came in, so figured we'd go ahead and hit those while we're close topic.
Sarah Ruiz: Absolutely.
Kevin Tate: Eric asked back on the record types, do you think that's gonna result in a flatter structure overall? Today we've got these hierarchical levels and, as we know, especially teams coming off of Windows, file systems have file path character limits that make things difficult when you're moving things around in certain systems. You think this will solve
Sarah Ruiz: Yeah.
Kevin Tate: a flatter structure?
Sarah Ruiz: Great question, but I actually think the structure will be very similar. I think the only change really, to conceptualize this, is that the record group is just another lower level of a section, so you're never gonna have things specifically filed at the section level, or like where you could have an artifact and then a sub artifact that ties into it and you're like, " where do I follow these things?"
A record group, if you're thinking about it in the term folders would be within the section and then all of your types would be within that group. So yes, the folder path consideration is huge. I think that's where you are going to rely on the UID of the record type versus the actual file name so you don't run into that character limit issue. Let's put a TBD on the clear answer for that.
Kevin Tate: Yeah.
Sarah Ruiz: A really good consideration and something that all of our vendors will have a year to figure out.
Kevin Tate: I know all those folks who are in Windows file systems, like
Sarah Ruiz: Yeah
Kevin Tate: ahhh file paths.
Sarah Ruiz: We did.
Kevin Tate: This is a high level question, but it feels like a billion dollar question... as we look at new metadata types, especially introducing things like optional expiration dates, do you think this will impact the GCP compliance burden? Is this likely to make that all more tedious in the long term or maybe it makes it better?
Sarah Ruiz: I think in the long term it makes it better. The tedium comes with the change of it all and getting everybody to adopt the change. CDISC is doing a brilliant job aligning with your regulatory bodies, getting ICH involved, making sure that they're getting input from more than just one group of people. There are over 70 people that have volunteered to be part of the consortium. Everybody wants to remove the tedium, so that's certainly the goal. Consistency is really the best way to do that and this will enable that consistency. It will be hard to adopt because it's extra work to prepare for. But in the long term it will certainly help.
Kevin Tate: I love it. Thank you.
Sarah Ruiz: Absolutely. Any other metadata questions or should we move on?
Kevin Tate: Let's keep cooking. There's more questions coming in, but I'm gonna line them up.
Sarah Ruiz: Perfect.
Kevin Tate: Yep.
Sarah Ruiz: Perfect. So just to talk about some of the new add-ons that are potential. And remember this is very early on. This is not gonna get released until Q1 of 2027. Things are changing. So what I say here might not be the final truth.
With new zones and sections, you'll have your CSV- not csv like Excel files, but computer system validation documentation- for translations. That could be completely replacing your EDC and IRT related zones, or we might keep those the same and move any additional things into that new zone. Still very up in the air. There's a lot of opinions surrounding that. There are places for you to submit your opinion to CDISC, even if it's just emailing them.
This is gonna be really applicable because all these new systems get retired at the end of the study, typically. They get decommissioned, especially if you're a sponsor or a CRO. You just wanna button everything up. You wanna archive it. And there's a lot of documentation behind that. A lot of study data that don't have a great place to go. I said it before, but electronic consents, eCOA, stipend, payment systems, data integrations. That is a huge chunk of work at the start of your study. And now you'll have that easy drag and drop, "oh I know where this goes" section. So yes, there are more record types, but for good reason because it's evolving into what we know now.
Kevin Tate: That sounds good.
Sarah Ruiz: When are we preparing for this? We know that it's gonna be published sometime in early 2027. If you are not using Kivo, definitely reach out to your vendors. Maybe you're a sponsor with a ton of different CROs and they have their own vendors that they use for the TMF. The recommendation is to start preparing now. You have processes that refer to sub artifacts and artifacts that you're gonna have to change. Start there.
CDISC and other bodies are doing a good job of preparing for training. There will be training that you can either get for free or some heavy duty paid training. So make sure you slot that into your schedule and your budget for 2027 or even late 2026. Starting now gives you a pedestrian pace to make informed decisions on how you're gonna adopt this new model.
Speaking of, me and the rest of the world and Kivo are very close to all of the updates that CDISC is gonna put out. Again, we have our monthly vendor committee meetings, so we are committed to having this ready when it's published. Change is bound to happen in a year, so things might change from now to then. You wanna be up to date and prepare yourself for changing your language, changing your processes, things like that.
Speaking of preparing yourself, you have study plans. I know that CDISC has a whole different committee to update the TMF plan template. Version three is currently on, so it would be V4. That will be adjusted and you'll be able to adapt that TMF plan template to your own organization.
I am unclear on whether or not you'll be required to switch your current, ongoing studies when this is published to the new model. My current recommendation is that you might as well. It's going to be work, almost a migration in itself, but there are so many advantages to doing so, whether it's archiving, whether it's submitting, and if you think about the fact that CDISC is like... the FDA, the PDMA, various other regulatory bodies around the world are platinum members of CDISC... reading between the lines, a standard and all standards must be adopted. It's just safe to plan for more work, not less work. You have the time.
Kevin Tate: And maybe
Sarah Ruiz: and of course.
Kevin Tate: double click on that second one for a minute. 'cause we got a question in about
Sarah Ruiz: Yeah.
Kevin Tate: I realize
Sarah Ruiz: Perfect.
Kevin Tate: about the thing that you just said. It's not clear yet, but it's a big deal
Sarah Ruiz: We can drill down.
Kevin Tate: It's a big deal if people are going to need to plan to move a study in flight to the new model. And it sounds like what you're saying is probably plan to much of the time. As a vendor who provides these things, we're assuming that's part of what we're gonna be helping companies do, right? We are fortunate that we already have a data migration tool that gives us some headstart on that. But we're assuming that existing TMFs and mapping them and moving them to the V1 model is something that we'll be doing. Am I reading all that right? Are there other considerations that you've heard people talk about in terms of when you will or won't need to move? Or when something is old enough that you don't have to worry about it?
Sarah Ruiz: Yeah. Archive studies, things that are never going to be submitted, I wouldn't worry about it. There is definitely going to be a lead up time. There's going to be a large grace period for implementing this. Kivo in particular is very committed to holding the organization's hand through this implementation, and providing guidance based on what's best for the technical landscape and for your particular studies.
From a technical perspective, switching everything over into the same model is probably easier in the long term. You don't have to have two separate work instructions, you don't have to have two separate things. You're not worried about these things. Just make sure that you have a clear, effective date. We will make sure that we can accommodate the new model and we know what it looks like to go from your current, structure to the new standard model.
In other words, there's no drop dead timeline but a written plan gets you out of hot water really quick.
Kevin Tate: Yeah.
Sarah Ruiz: Maybe just have that plan say "Yes, of course, we haven't done it yet because we're still in this step of the plan." Does wonders.
Kevin Tate: My naive follow up question here would be, does the connection between a phase one, two, and three study matter in this context? Would you say keep it all in the same or make sure it all switches or does it just not work that way? It'd be fine to have one, two in the old and three in the new?
Sarah Ruiz: It does matter. I don't have a good way to articulate why it matters right this second. But for continuity potentially moving documents into the new study, it would matter. If you never plan on submitting the trial, that's a totally different story. But when it comes to a regulatory authority reviewing your data, they will be much happier to see the new standard model than the old, if that makes sense. It's going to be a study by study decision.
I'm a huge spreadsheet matrix kind of gal. Have your decision matrix, like "if this, then this". Identify the risk of not doing it versus doing it. That's why starting now is really good because the landscape of your trials will change . You're not gonna wanna delay any study startups waiting for the new model.
But, let's say you start up a study in March of 2026. It's gonna be a two year study. You should probably write in your study plans when you plan to adopt the new model and what that looks like for that study. So it is very hard to put a blanket statement considering every study is a little bit different.
Kevin Tate: Yeah,
Sarah Ruiz: I should stop saying study. I should start saying trial, but it's gonna take us all a little bit of time
Kevin Tate: Another good question specifically on the timing. For those who are not part of the CDSIC feedback committee... will the new structure be released publicly or to the industry in 2026 then? Have they said when?
Sarah Ruiz: That's my understanding. It'll be sometime late 2026. Definitely stay close to the CDISC's news, because you'll be able to review and submit feedback.
It is going to be changing, so not necessarily like a "speak now or forever hold your peace" situation, but it is always helpful to see things through a different lens. So my understanding as of right now, is that it will be made available to the industry prior to being published for those last minute considerations.
Kevin Tate: I got a great question in about, hey, if we are moving from the old format to the new format, especially if you've got multiple records under a single sub-artifact today that need to go to these new record types... there's gonna be a mapping exercise.
Sarah Ruiz: Absolutely.
Kevin Tate: And so the question is, if, and how much, one can expect Kivo or other vendors to be able to help with that? Or is it gonna be a manual thing that, to your point, when you make that plan, you should assume there's gonna be a bunch of manual work to remap.
My quick answer would say, yes, we've got tools to help with that. I'll assume other vendors will also have tools to help, but it won't be, magically push a button and everything just goes. Some of that we'll be able to automate and some of that we'll be able to map and confirm. Anything to add on what that mapping exercise is likely to be and how easy it's gonna be for tools like Kivo to automate?
Sarah Ruiz: Yeah. Great question. You're exactly right, Kevin. We will have the tools, we will assume the mapping for you, have you confirm, go have that back and forth. So I think the initial chunk of work will be done by Kivo. Then the decision is ultimately up to you on where things are supposed to go.
We're never gonna decide what to do with your documents. We are more than happy to guide, consult and help give you the information to make good decisions. But it will take work. It will be an exercise. I'm gonna use a KT word, but it's not gonna be "automagically" done overnight. It might take some time, but it won't be so burdensome that you have to dedicate a full-time resource to do this.
Kevin Tate: You mentioned a few minutes ago, we gotta start saying trial, not study. And I acted like I totally knew what you meant and said "Yes, absolutely." What did you mean? Did the FDA say we can't say that we should start
Sarah Ruiz: No. It's more of a semantics thing than anything. It's just because the standard model... it's going to have specific control terminology and I just happen to know that it was agreed that trial will be the consistent control terminology to reference that thing. So it's not like "study" is gonna be turned into a bad word or unusable. It's just for the sake of this conversation, trial is the consistent control term .
Kevin Tate: Cindy, hi Cindy, points out that participant versus subject or patient is another terminology that is sorted.
Sarah Ruiz: Yes, I think participant is probably going to be the way to go. There's always been a little bit of, what's the right term? Maybe Cringiness? When talking about people and calling them subjects. It's one of those things.
Kevin Tate: Got
Sarah Ruiz: I'm eagerly anticipating those sort of changes.
I think last but not least here is just more of a philosophical thing. You might have the best plan in the world, but this is new. Nobody's ever done it before, it's new to everybody. Maybe you're a CRO doing an RFP for a sponsor. Maybe you're a sponsor looking at a CRO timeline. Maybe you're creating your own timelines. Just pad it a little bit. Give yourself the time to make the adjustment. Not to the point of pushing back first patient in or anything, but just account for the learning curve. Because there's nothing worse than having a poor expectation and then not being able to meet it.
Kevin Tate: Yes.
Sarah Ruiz: Okay, we are nearing some of the fun stuff to keep up with the latest & greatest. I've mentioned CDISC so many times, and that's for good reason. It's because they are the end-all-be-all to this. It is their standard model with really good input. I'm actually really impressed with their webinars. They're engaging, very informative and they don't necessarily overpromise things that they don't know yet.
The latest webinar was today, so I'm sure that recording will be available very soon if you didn't get a chance to watch it. A lot of really good graphics in there that I wouldn't dare steal, but they're there and they're great. And also I know at least one virtual training session will be hosted in January. A lot more will be coming out. There's such a growing need.
People are asking a lot of questions. As far as I know right now, there's gonna be an intro to the TMF V1 standard model, and then some more bespoke or higher content driven training sessions.
When I mentioned budget that's what I meant here. If you have TMF managers in your organization that are going to be your subject matter expert, make sure that they're trained and know the latest and greatest if they're not already doing it on their own. Knowing the TMF managers, they probably already are! So good for you if you already are.
Just in Time GCP, they're the organization coordinating the vendor committee and hosting those calls. They are a great resource for incorporating GCP and the new guidelines into your TMF and what's right, what's wrong, and what's best practices. Shout out to just in time GCP, they have really good resources on their website.
And of course, come hang out with me and KT! This will not be the last webinar on this. Like I said, there's gonna be new information, new techniques of how to adopt this and implement this at your org, so just keep your eye out for future webinars. Maybe they'll be more product specific, maybe more education specific. I just know that they'll be happening. So come hang out with us. We'd love to have you.
We have plenty of time for more questions and, some chitchat. So what else do we have, KT?
Kevin Tate: Thanks. We have some great questions. If you have any others, feel free to chime in.
I was really interested in what you said way back at the beginning. You said, preparing for more machine readable TMF and documentation, and since we're contractually obligated to mention AI in any webinar in 2025, that sounded like the AI part to me!
But seriously I do wonder, to what extent is following this new model or the way you structure and present things teeing up for more automated or AI assisted reading and ingestion of these documents, or am I just projecting there?
Sarah Ruiz: I think it's a little bit of both. I think that with standardization, regulation quickly follows. We all know that AI is a great tool when applied correctly. But I think that there is going to be some obvious adjustments. Privacy and security and all of that good stuff. I think initially what I meant with machine readable is similar to an XML format to read your data. So just making it standardized so that programs can be built to extract data, not necessarily via AI, but just with tools that can be built.
Now, are there use cases for AI and TMF? 100%. Some people are already using them, but then there are complications, right? Your PI might submit a 1572 and the date is not the format that the AI is expecting and it rejects it automatically and you're like, " I wouldn't have done that." It might create extra burden on you. Overall. Great tool. There are edge cases that need to be considered for it to be a perfect tool. So yeah, I think it does tee up the industry and specifically the land for is with AI because there will be consistency and easier to program that sort of intelligence.
Kevin Tate: It seems like more structure certainly is a step in that direction, which to your point... you mentioned earlier in the beginning that a more risk-based approach is part of what's reflected here and bringing in some of the E6 R3 principles. Do you [think in] general that some of those critical to quality themes are what we're seeing may be reflected in the way the standards being looked at or the conversation around it?
Sarah Ruiz: 100%. I think that there is going to be more considerations for data governance, we're considering the archiving of studies, and CROs, we love you, but essentially it's the sponsor's data. So it's going to help facilitate the transfer of your TMF data once the study's closed out. Decoupling it from the CRO side, giving it back to the sponsor's side, there's going to be things where you have a menu of record types that might not apply to your study, so you can just exclude them from the get go. Instead of having 2000 placeholders, you might only need 500 different record types for your study. Maybe you're not using an IRT 'cause it's a really simple phase one study. It's an unblinded drug. Maybe you're not using a central lab. You don't need the whole gambit of lab documentation. Or it's just a really small investigator initiated study you're doing at one university. There's just so many considerations. And I think what this allows you to do is, to adopt the CDISC term is have that sphere of considerations. You start with what you know you absolutely need from a regulatory perspective and build up from there based on your study requirements.
It's really good to start all of that at the same time as you're building your protocol, as you have your study plans, as you have your recruitment plans, and figure out what's happening. Risk-based monitoring has been a thing since at least 2012. I think there will be better guidelines on how to file those things and what to do. It all is lining up to be one solution that makes sense. One set of guidelines that makes sense without contradicting each other. So definitely I would expect to see things that promote oversight for sure. Proportional to the safety risk, to the data risk, which are the two big considerations in the grand scheme of things.
Kevin Tate: I heard you say a couple of times today, when in doubt, make a plan, document the plan. If you've got a plan to show around it, that can pay dividends later on. Sound advice.
Sarah Ruiz: Yeah.
Kevin Tate: Thank you to everyone who joined and asked great questions.
It was fun to explore it with you and we'll see you at the next Kivo webinar! Take care everybody.
Sarah Ruiz: Take care.
