 We now have about 20 minutes for Q&A and if Dr. Schwenk and Dr. Lina are available we'd love to involve them in the Q&A. So go ahead and post your question in the chat and you can also unmute yourself if you'd like and I also have a mic here for anyone. Great talk Vinod. I have a question in terms of the natural language processing do you have access to progress notes within VA data within the arches platform? The way the process works Dr. Migrino is that investigators who already have access to these notes they have to get onto a process so that the notes that they already have access to can be approved to be aggregated into the innovations ecosystems environment and once the notes make it to that destination then the MD clone Adams platform can directly interact with those notes to get targeted information out and convert them into structured information. Do you know if any researcher or QI person has I guess imported Vista data into the platform? And clarify that question for me Dr. Migrino when you say imported Vista data what domains of data are you? So within the electronic health records the notes as you know unstructured data are residing a Vista platform and I believe you can get permission to get that and I wonder whether that is part of what is could be available within the arches platform. Yes you're right it's about proper approvals and permissions there's no barrier other than proper approvals for co-locating those notes copies probably in the VA innovation ecosystem environment and then the moment that happens remember Dr. Linao mentioned that the innovation ecosystem is a wall to playground so the permissions would be needed to get into that space after which and I'm happy to state that there are about two or three groups now that have begun to think about these possibilities bringing in their notes that they that they already have access to all they need to do is get into a process whereby there's approval for bringing these notes into the VA innovation ecosystem environment. So Dr. Marisa Domino has a question for Dr. Schwenke I'm reading from the chat and Marisa you're welcome to unmute as well if you'd like Dr. Schwenke what are the costs for using the Vinci environment broadening this can you provide the costs for all the platforms discussed for non VA researchers? I can only speak to Vinci I I haven't used the MD clone or the other platforms so if one is approved to use Vinci there's no cost however through the dark process there will be a requirement for either an IRB approval and an R&D approval or for preparatory research a letter or form a testing that the person is a VA employee and they wish the data to access the data preparatory to research and and affirming that they won't download and things like that so so there's no cost it's just it's only available to someone who is in in detecting halarchy a VA researcher so that includes individuals who are VA pay excuse me VA paid employees and VA and individuals who have a VA without compensation or WC appointment so the the without compensation appointment is essentially a mechanism that VA uses to vet an individual to assure themselves the VA that that it's safe essentially for the person to have access to VA resources does that answer the question? I think it does but Vinod go ahead and Dr. Schwenke I'd like to add to what you said and this is about the costs for the MD clone Adams platform there's no cost for using the MD clone Adams platform and the process is simple if you're interested and have a PIV card which proves that you have you know identified you've been identified at at the VA then all you need to do is submit an email request stating that you are interested in using the platform and the access is instantaneous all it takes is for our customer success partner to give you access and then you you just go ahead and start your research design with support that's provided by us which also has no cost and and frankly most researchers don't need that much support once they get into the platform they start the process of evaluating feasibility of their research or their quality improvement project okay yeah thank you Marisa wow free and amazing thank you both all right um any other questions or comments my question is for Dr. Schwenke it's so nice to put a face to a name I'm Jeanette Coffey by the way hello I've been emailing you and my question is regarding the timeframe I know it may vary um for non VA researchers but what is the timeframe to get access I'm just trying to think strategically to plan research projects down the line I'm at the University of Arizona I'm a postdoctoral research associate and so I'm trying to plan strategically what timeframe should I be looking at um if I do go the non VA route to gain access to um Vinci or the CDW production data um I would love that insight thank you yes so by the non VA route I'm presuming you may need that you would seek a WOC appointment so that takes a couple months and it's some forms that that you would be required to complete and then there's a background check done and that that's probably the thing that is the most variable on length and then there's some training that would be required VA it has certain training requirements uh and then but simultaneously to doing that you could certainly develop your project idea um you you would need to have your WOC appointment before you could submit to the VA IRB but that's not to say that you couldn't have everything ready and until you know wait until you have the WOC appointment then do the submission um and and again the the time through the review committees the IRB and assuming that there's this only data study so there's no laboratory issues um it varies depending upon the person basically depending upon how responsive they are to request for revisions um if if there are anything that are needed so so um in in addition to the IRB paperwork which is probably pretty similar to what you would complete um at U of A or any other university there is the need for a a form that the privacy officer reviews uh and another document that the information system security officer reviews so so that is the particularly the one for the information system security officer that is the one that can be the most challenging for people however we have individuals on the research service that can help you and certainly if you are using uh proposing to use VA data and it's in the Vinci platform that's something that's easy for the information system security to sign off on uh because his job uh is to make sure that the use transport and storage of VA data is in a manner that meets VA security requirements and uh accessing and using and analyzing storing the data in Vinci is an approved VA solution so um that's a long answer of saying uh the the processes so I would say if you are responsive to respond uh request for revision uh you should be able to from the time of submission uh of your IRB approval I mean your documents for IRB approval to the RMDC approval which um you um let me see now uh and thinking about when you can submit the dart um uh it the probably the total time from when you submit the IRB to when you get approval from dart uh would be three to four months if you're responsive now I'll give you go on vacation and you know I'm able to respond to critique and you know miss a few periodic meetings or something like that it's going to take longer but but if you're really on top of things you should be able to get it done in four months and then the law appointment six to eight weeks thank you hi there um this is just a general question for any of you most of you mentioned demographic data would be included in the in the databases available um I never heard a mention of racial data and the reason I asked this is because you know because you're stripping out a lot of other differences sociological research like sociological health research when this would be like a really good source for that kind of research no race and ethnicity data is definitely available um go ahead dr schwenke yes it is definitely available however there is um a fairly high uh percentage of percentage of missingness and as to say uh individuals who choose not to identify uh their race and ethnicity so the way I've handled that in the past is is just to consider that is another race ethnic group people who don't want to identify or don't want to be identified so that's one approach uh that may be less biased than just excluding people for which race and ethnicity is not available other questions so I don't know if this question is for individuals that can answer in the room but I want to ask it anyway so a couple of weeks ago we had a military and veterans resilience and health collaborative conversation and with all the data that's available now we're thinking about running clinical trials or what have you one of the larger hurdles that we always come across with va um in particular or government entities in particular is the timeframe for approvals um a lot of times what gets left out is the end goal of that is servicing veterans and also the service members right so if there's approvals on the if there's slow approvals on the front end ultimately those results affect veterans on the back end for the things that we're looking to at least find an answer for um what do you all think we can do better um to circumvent that because ultimately if we can find these answers faster for veterans there may be some things that we can implement for service members that are going in prior to their service that they can probably implement in basic training things like that so Dr. Schwenke do you have any thoughts on that question um so from what I thought I heard is that if we could accelerate the process of providing access to data and and uh completing clinical trials and things of that such information could be gotten to veterans more or any an active duty service members in time to initiate preventive action that's I thought what I heard so so it sounds like that's a question about how do we accelerate the um the approval process um um that that that actually um there um possibly some discussions about the steps and the approval and uh among all stakeholders to see if there maybe there might be some flexibility that uh uh could arise uh or will not arise a flexible that could be uh developed or some sort of agreed on process that that could fast track uh some things now as I mentioned uh when for Dr. Coffey's question there's certain things that are easy for our information system security officer to sign off on and that's one of the steps that to get anything uh approved in in human sexual protocol approved is the information system security officer ISSO has to sign off and so if there's you might say an upfront agreement that um uh to expedite approvals uh data will be kept safe for example in the Vinci platform that then is a quicker approval uh because if it's some the the situation is if the requester makes a request to store data on a platform that is familiar to the ISSO and that is something that is he knows they're all men uh he he knows is approved by VA then he can easily sign off if it's something that he doesn't he's unfamiliar with uh or that he's not sure about then uh either he or we in the research service need to do some exploring and learn about the platform and and give him the specs so then he can see uh if it meets VA security requirements so um that's an example so if stakeholders were to get together having meetings say this is our end goal uh we want to do a clinical trial on XYZ we want to do it in efficient manner and we want to design it in such a way that it can be quickly approved what are our options uh that that potentially could lead to discussion of well where can we where should we store the data so it can be most rapidly analyzed and meet VA security requirements or if if these are active duty military uh DOD uh security requirements I I don't know their requirements but I assume they're somewhat similar to uh to the VA's uh so uh I hope that kind of gives you a flavor of of where we might go as far as getting stakeholders together and trying to brainstorm solutions that would would either overcome barriers or accelerate uh steps required steps I think a couple you know themes I heard is uh is that you know it is important to have really a VA partner and ideally an investigator it's not simply working with the research office as capable as they are um it really helps to have a champion someone who's interested in your field or you know tangential field so I think that's really important um so obviously teams are important to create go ahead I'd like to add to that uh the speed from idea to the final output is dependent on two or three things number one being able to evaluate your idea rapidly and come to a realization of the actual goals of the project whether you're submitting it for an IRB approval or for clinical trial purposes so I think access to a platform that does that such as the MD clone platform within the uh innovation ecosystem has really helped that um secondly if you're thinking about let's say pursuing a clinical trial in silica research using real world data within the VA is important to to inform such trials and that again is possible using platforms such as the MD clone platform thirdly the quality of the data and the perception and understanding of the quality of the data by the researcher is important to inform the speed in how they decide these projects and submit to the IRB the IRB approval process sometimes comes back with questions and um this direct access to data to clarify those questions is important lastly I want to mention the data quality is important for and what's happening nowadays is people are thinking about AI and ML projects for prediction and other purposes and that data quality is important and the understanding of that by the clinical researcher themselves oftentimes when you have a middle person who understands the data but the clinical researcher doesn't they find it difficult to take those projects from you know the idea to the end so all these things I think will will help in shortening this process for clinical trials and other areas of innovation yes great thank you very much um I'm still a little bit confused about how in a non-VA person researcher would really get access what I'm hearing is that there are lots of tools to develop your ideas but those are only available if you're within that VA firewall and yet there's a IRB process outside of that and then probably inside the VA as well so I guess I'm really wanting to know how it does a non-VA affiliated researcher start this process let me try to answer the question from my perspective and I'm sure that we have chiefs of research from both Phoenix and Tucson who could add to this I think the term non-VA is a bit I would like to maybe change that to non-VA to become VA so the typical process for a university investigator is to to ask for without compensation credentials i.e. become an unpaid VA employee so you actually become you have all of the rights and responsibilities of a VA investigator so you're really no longer considered non-VA and so at that point you're 100% VA now you know there may be modalities of collaboration with external companies and universities and other things that are outside of that truly external parties I cannot speak to that but I think for the typical university investigator it's simply to get VA credentials yes there's you can't put an IRB until you're a VA investigator yeah and so that process I think Dr. Schrenke said it takes approximately three to four months if the person is very diligent well okay I'll say a couple months but I was thinking of the getting from from the the submission to having the data in your hand or having access to the it's not in your hand but having yeah so Tom where go ahead I'm sorry I just want to add during my presentation I'll be discussing the steps that I've taken from a non-VA researcher to where I'm at now with my full IRB execution so you'll be able to see each of those steps along the way so I'd like to add to that and actually Dr. Dave has had the experience of doing that so yes you got to get you know these official credentials to actually start the work but even prior to that it's for the person who doesn't have a VA credential yet so for example every major medical school is associated with the VA okay and by dint of those associations almost all major universities have association with the VA now it's an opportunity for all these interested parties be they data science people epidemiologists health care to get in touch with and find out who the PIs at the VA are and sort of correspond with their ideas and then eventually get on to the the process for getting under the fold of the of the VA PI team so I just wanted to add to that there are several examples of that actually all three of our presentations later this afternoon we'll talk about how a you know so-called non-VA person collaborated on the team to do the work right I think two out of our three presenters today you know started off as non-VA persons and we'll be hearing from them very shortly let me also let people know we do have a sign-up sheet if anyone's interested in getting contacted by the Phoenix VA the Tucson VA or VA arches MD clone and we'll also be sending an electronic survey after the meeting to ask the same question I think we've had some great questions and I think you're going to get some of these questions answered at the next round which will start at 10 15 so enjoy your break