Date: April 25, 2017

Cyber seminar Transcript

Date: April 25, 2017

Series: VA Informatics and Computing Infrastructure

Session: Data Access Request Tracker (DAT) 4.0

Presenter: Ron Simpson, BSF
This is an unedited transcript of this session. As such, it may contain omissions or errors due to sound quality or misinterpretation. For clarification or verification of any points in the transcript, please refer to the audio version posted at http://www.hsrd.research.va.gov/cyberseminars/catalog-archive.cfm

Ron Simpson: Okay, well, good afternoon everyone and good morning to some of you. Again my name is Ron Simpson and I’m here to present on our DART 4.0 Data Access Request Tracker. A few things about DART. It’s an online application for both Preparatory to Research Activities as well as IRB and R&D approved research access. And DART is not for operations use. That is a different program. DART also automatically determines documentation requirements based on the data that you request through the DART wizard, and so it then distributes these requests to NDS reviewers and other approving data stewards. This allows for one stop shop reviews, approvals, change requests, denials, monitoring, and tracking.

The communication tool within DART allows for questions and answers between the requestors and approvers, and it’s a little icon located at the top right of the DART screen, which I’ll be showing a demo of momentarily. The history tool, also in the upper right hand corner, provides date and time stamps for every event that takes place within the DART, so you can do tracking of what happens in DART itself. The DART dashboard allows for display of the actual approval times. So you may go through several different layers of approvals, and it will display those times in the dashboard itself. And then DART also will send out email notifications as your DART request progresses and is ultimately approved. Again that goes to your VA email, so you really do want to be checking your VA email consistently once you place a, submit a DART I should say.
The DART User Guide is now updated and is on every page, again in the upper right hand corner of the DART screen, for your convenient reference. It does have some great new items in there and information. So I would definitely take a look at the new User Guide. DART also has a new look and improved feel. We’ll show you that here in a moment. Again, I’m going to be touching on, we have incorporated Prep to Research process into the DART application so that all research related processes are in a single location. And then as you can see on this slide here, we do have an easy to navigate toolbar on the bottom of each page, so you can go previous, next. You can save draft, and you can hit the validate button to make sure that everything on that particular screen is done properly.
Now here we have our poll.
Moderator: And the poll questions are up. The question is how familiar are you with DART? Choices: What is DART? I have looked over someone’s shoulder, I’ve submitted a few DART requests, and I am a Jedi master and teach others the DART process. The poll is open. We have about 60% people voted. I’ll leave it open for a few more moments. Now things have slowed down, so I’m going to go ahead and close the poll and share that out. And Ron, 45% of your attendees answered what is DART, 26% answered I have looked over someone’s shoulder, 21% I have submitted a few DART requests, and only 8% are strong in the force and answered I am a Jedi master and teach others the DART process. Back to you, Paul. Ron.
Ron Simpson: Excellent! Thank you, Rob. Well, I guess it’s good thing I’m putting this on today as 45% of you don’t know what DART is. So I’m going to continue on and give you more material about DART so that you can ultimately become strong with the force.
So why use DART? It’s a one stop shop for research activities, and this the way that you gain access to VHA national data for research. Again, I’ll hit on a fact that we do have the Preparatory to Research access now in DART as well. And we have access to CaPRI for research purposes, which CaPRI is an online tool for national electronic health records, and so you can gain access to those as part of your research study. And we’ve incorporated a centralized secure environment with a single sign-on feature and integrated services.
Some of the DART required documents are going to include your research request memo, and these are in no particular order, your IRB approval letter from your institutional review board, your research and development committee approval letter. Of course we need your research protocol. If you are doing any sort of informed consent, we do need a HIPAA informed consent and authorization and/or a HIPAA waiver. If you do need real SSN access for your particular study, there is a form for that. And any additional data source-specific forms such as the CDW checklist, the surgery quality data user’s group checklist, and several other ones. All of these forms can be found on the VHA Data Portal. And I will have those links for you at the end of the presentation.
So what’s new in DART? Of course again we hit on the Prep to Research is now incorporated into the DART application. It’s great because we’re a one stop shop. We’ve incorporated single sign-on now, so you can use your PIV card to sign into DART and no longer need a user name and password. And again, we do have the DART User Guide link on the upper right side of each page in DART. We’ve done significant DART performance improvements. There’s a lot more under the hood these days, and it runs quite a bit quicker. We’ve updated the change requests and the way that they’re handled. We have participant tracking so that if you are removing personnel from your study or you’re adding personnel from your study that actually will be recorded in the history portion of your DART. You can have us delete unneeded requests now. And the big caveat there is that they cannot be submitted. Once they’ve been submitted, we can’t do anything for you. But if you do have an unneeded DART request sitting there, you can send an email to [e-mail], and we can take care of that for you. We also have kind of tweaked the document names as previously they were long and incorrect. So we do now have a better naming scheme. And I’ll show you that on the demo itself. And the data sources are now checked by individual participants, especially for the CaPRI wizard. And you’ll see this on the Participants page. But you can actually, if you do need CaPRI, you can click on access for only the individuals that actually need to go into CaPRI itself.
Alright, it’s demo time. This is basically the first page that you’ll see once you get to your DART dashboard. The red arrow shows the box for Create a New Request, and that’s the first thing that you’re going to want to click on. And then you’ll see in the other screen shot there where you type in your official study name. And then you request the type that you’re doing, whether it’s the Preparatory to Research or an actual research study. And then you would click the blue box at the bottom to actually create the request.
So once you create the request, it goes to the first Activity Information page. As you can see, I’ve mentioned before the History and Communication tools in the upper right-hand corner. You can see those now. And for the activity information, you’re basically going to put in your short name of the study that you’re doing, unless you have a short enough name that will fit in this box of the actual official name. You have your IRB number that you can put in there as well as the IRB expiration date. You want to keep an eye on the IRB expiration date because as each year goes by you’ll need to update that through an amendment. You can put in the start date of your study and then your anticipated end date of the study. Most studies go for several years, so we want to make sure that that end date is indicative of how long you think the study is actually going to go. And then the bottom right-hand corner you can click on next to go to the next page and we’ll go ahead and do that.
Now this is our Participants page, and as you can see, I’ve already loaded a couple of participants in here. But essentially how you’re going to find your participants that are going to be on the study itself, you’re going to click on the Find People button that’s in the king of lower right-hand corner. You’re going to type in last name, comma, space, first name. It’ll bring up a list of, say, Ronald Simpsons that are in the VA. Obviously you want to pick the one with your user name. And then you can select the location that you’re at. Since I’m in Salt Lake, I selected Station 660 which is here in Salt Lake. You can also click on the 508 Compliance button, and that will bring up another scroll down list where you can see all of the different stations. So once you’ve selected your location, you have three different boxes to check, and this is for notifications, which are emails sent through various systems within VINCI to your VA email box.
Data Access is a required checkbox for anybody who is going to be actually seeing the data or utilizing the data within the study. And then if anybody needs CaPRI and VistA web access, then you can click on this CaPRI box, and that will automatically check within DART itself. It will check off the requirements of having the real SSN request as an identifier checked. It’ll click on VINCI as the data storage location as well as click on the CaPRI data source. All PIs, you’ll notice on the right side that your principle investigator is going to have the darker filled-in star, then any co-investigators from, say, any other locations will have a open star. So once you have that in there, you can always go back to it, but for sake of this, we’re going to click next and go to the next data sources page that I have broken up into several different screens because it obviously doesn’t fit on one screen.
So your Data Sources page here. This is going to give you your data storage location right at the top of it. You can pick VINCI, you can pick your local server, and you can pick both. Now the advantage of picking both is that you are then giving access to be able to download data from VINCI itself to a local server location, and that local server location is something that your Information Security Officer would know of where the actual server is located at your facility. So you fill in those boxes there, and that’s going to allow me to, like I said, download data if I’d liked to.
The next part of the Data Sources page asks if you’re going to transfer any data external to VHA. Most of the times your answer is going to be no, but on the times where you do need to collaborate with a different agency, you would click yes on this, and then you would work with our people at National Data Systems for the data use agreement that must go into action.
Then you see your identifiers. You have three different ones, a real SSN and that requires the real SSN form, scrambled Social Security numbers, and identifiable data but no real or scrambled Social Security numbers. And once you’re in DART you can actually click on the More About Identifiers hyperlink that’s in here that’ll take to another seminar put on by one of our data managers to talk more about the identifiers.
So we’ll go into the next portion of the Requested Data Sources. This is where you can check off the boxes that you actually need for your study. Now if you don’t know about what you really need, we have different links to our data portal, or VHA Data Portal. There’s links to CDW and VIReC for data sources and more about what they are, and so basically this gives you a snapshot of what’s available. Now what you do see here is everything is going to be in SQL format. So I am going to stress that when you’re doing a research study within DART, you are going to need someone who has SQL skills and can manipulate and analyze the data because it’s coming to you in a database form. The SAS format is no longer available. So we’ve converted everything into SQL format above. And then you do have the ability to access the mainframe for specific data sources and that requires another level of access and another form to fill out.
But, we’ll go to the next page here. And this is actually the end of the page for the data sources, and as you can see, we’ve got CaPRI and VistA web, we’ve got CAN Scores, we’ve got Heath Economics Resource Center data, Homeless Registry. Currently the OEF/OIF roster is not available, so that box is grayed out. If you need more information about that roster file, you can email us a [e-mail], and I can give you more information about it. If you do need surgery data, we have the Surgery Quality Data Users Group, so you can also check on that data source as well as VSSC Web Reports and then our SAS Grid. And then it does ask for, if you’re going to be, your study requires informed consent and HIPAA Authorization and does your study require HIPAA Waiver. One of those two needs to be checked yes. And the majority of them have just the HIPAA waiver. But if you’re going to be actually recruiting subjects, you’ll need the informed consent as well.
Okay, so now we go to, this our Required Documents page. And as you can see, based on the DART wizard and the data sources that I selected previously, it’s going to tell me what forms I need to upload. Now a lot of these forms you’re going to already have, like your IRB approval letter, your sample informed consent and HIPAA authorization, your R&D approval letter, your research protocol, so on and so forth. Some of other documents that you will need to fill out and upload would be a Research Request Memo. For this particular one, you’d also need a CDW Domain Checklist which outlines the data that you are actually going to request. And because I checked real SSN as my identifier earlier in the DART Data Sources page, it’s asking me for the real SSN access request form to upload.
As you can see on the right, we’ve got an upload button that allows you to then go out and search for those documents on your computer. And then the second part of that is the fact that I had a second person in there from a different site, we do need an IRB approval letter, an R&D committee approval letter, and waiver of HIPAA authorization from that site itself to also be able to upload within this DART. I also clicked on Vital Status as a data source, so it’s going to ask both me and Jeffrey Scehnet for our Vital Status Rules of Behavior. And then we would upload that as well.
So what this shows now is if I go to the next page, which is the Submit page, and I hit the Submit button without uploading anything, I’m going to get an error. I’m going to get a lot of errors. And it’s going to tell me hey, you need to actually upload the forms. So what I do is I click the previous button, which is not shown in this slide, but it is on the bottom of the DART there. And I’ll go back and at this point then I go ahead and I uploaded the documents.
As you can see, the naming convention there is now for the Research Request Memo it’ll say Research Request Memo. They give you the station number and the location that you’re at and whether it’s a Word document or a PDF. And that also is going to date/time stamp when you actually uploaded the forms and who actually did that. And it’s also going to give you a version number, so version one obviously is the first time I’ve actually uploaded any of these forms. If I, in a year from now and I need to update the IRB approval letter for continuation approval, then I would just go in here as an amendment and click the Upload button, upload the new IRB approval letter, and it would change to V2 for version #2. So I upload the rest of the documentation as well that you can see here, same naming convention, date and time stamped.
And this is our final Submit page. As you can see, we still have the History and Communications tools buttons on the top there, and we have a big blue button right in the middle that says Submit Request. Once you click that Submit Request, you want take a look at your VA email because you are going to get an email that looks pretty much identical to this. And it’s going to give you that, the email that says your DART has been initiated and please read about this before submitting the request.
So what this does, actually this is the initiated email. I’m sorry. So anyway, this is what you get when you first initiate the DART. And then it gives you some DART considerations as far as that goes. And you do want to click on that, on that box to give you some more information. I’m sorry, that attachment for more information on the DART considerations.
Okay, so now I’m going to just go into the same kind of demo as what we did for our research request, and this is going to be for Preparatory to Research. So again I click on the Create a New Request button, and I’m going to put in my official study name or what I intend to be the official study name once I go to, once you’re done with this, and you go to the IRB. This Preparatory to Research Access is for pre-IRB use. It’s not for use once you have IRB approval. So it’s to go in and try to find some of the data that you believe is out there and that you want to make sure you have enough data to be able to do a full research study. So I put in the study name. I would click on Preparatory to Research Access, and then I would click on Create Request. Now it’s going to take you again to your Activity Information page. There’s not as much as the research study to put in. You’re going to put in your proposed protocol name and your expected IRB submission date. Prep to Research studies are really only supposed to be about six months or so. So try to keep it under six months, and if you need an extension you can always contact us at VINCI again.
Again, here is the Participants page that looks pretty much identical to what we saw before in the research portion of the demo. And again you’re going to find people by clicking on the Find People box, the blue box. Type in last name, comma, space, first name. You want to select your location, and then you’re going to need Notifications, Data Access, and in this case I clicked on CaPRI and VistA Web Access just so I can be able to go into those electronic health records and find more information.
Once I do that, I click Next, and because I clicked on the CaPRI button, you’ll see that the VINCI Storage Location is automatically checked. And that’s actually for all of the PTR studies because there is no local option for a local server. My identifier is already checked as real SSN because CaPRI requires real SSN access. And then I’ve also checked on the CDW Production Domains, the Raw Domains, and my Vital Status File.
This is the rest of the Data Sources page. If I do need mainframe access, I could certainly check those boxes as well as anything else. But you’ll also notice that because I clicked CaPRI access for myself, the other data CaPRI access VistA Web is already checked. So that has been incorporated into DART as well. And of course it does say that individuals needing this access will be selected on the Participants page and does require real SSN approval.
So we get to the Documents page again. And so you’re basically going to put together a Preparatory to Research memo. And again that form can be found, actually all three of these forms that you see here can be found on our VHA Data Portal. So we’ll also need to upload our Vital Status Rules of Behavior and the EHR Access Request Form, and that’s for CaPRI/VistA Web.
It’s shrunken down a little bit on the screen size here, but as you can see the required documents. I have the Preparatory to Research Memo. I’ve uploaded that, date/time stamped it. It told me, you know, it’s the PTR memo at station 660 in Salt Lake, and it was a Word document that I had. The Vital Status Files are, I’m sorry, the Vital Status Rules of Behavior and the EHR Access Request Form, you can both see are named properly as well and are date and time stamped and by who actually uploaded them. Again, we’re on version one because I haven’t done anything else. So that is the required documents portion.
I do want to point out on this slide, though, if you go to the top under “Notice: Always check the Data Steward’s website,” and there’s a hyperlink for DART Process and Forms. That takes you to what I keep referring to as the data portal, VHA Data Portal, so that you can actually go directly to this page to get those forms. And we do update forms periodically, so you always do want to go out there a look at what the newest, latest, and greatest version is.
I get to the Submit Request button again, and at this point it’s showing that everything is complete. And so I can go ahead and click on the blue Submit Request, and it will be sent to the appropriate Data Stewards.
Again, this is the wrong slide that I pulled, but this is going to give you, you know, basically your email of what it’s going to look like when you initiate the DART and then submit the DART. It will look almost identical.
So I have a few tips and tricks. One of the biggest questions I have is when do I need to update a new Research Request Memo? And the answer is if you add a data source through an amendment, if you add or remove participants from the DART study, excuse me, including a change of PI. Sometimes studies will have a change in PI, and so that’s when you need to not only update the Research Request Memo but IRB information, so on and so forth. The Research Request Memo does need to be signed by three different entities, the PI, the PI’s direct supervisor, and the Information Security Officer at your local facility. So that’s something that you’ll want to find out is who your ISO is so that you can get them that form.
And then on, for CaPRI, on the EHR or it’s also called the Special User Access Form for CaPRI, on line items 22 and 23 we want the ACOS of Research, your Associate Chief of Staff of Research, to sign that form. There isn’t directions out there right now on who signs that, so I wanted to throw it in here as well, and we will work on getting that information put up on our VINCI central website. If you’re not sure about an item, please contact us. That’s what we’re here for. We’re here to help and we’re here to answer the smallest of questions to the largest of questions.
So what do you expect after you receive your DART approval? Well, you’re going to see an email from DART showing that your DART has been initiated. You’re going to receive a VINCI email, a welcome to VINCI email that your VA login credentials for VINCI have been logged into the system and that you can actually then access VINCI itself into the remote desktop protocol. This is why you want to continue to check your VA email because these emails are sent only to VA email addresses. They cannot go outside of VA. And then after your DART has been approved, an email is also set up and is sent to your VA email address for a SharePoint correspondence site. It’s a secure site in which you’re going to communicate with your VINCI data manager that’s assigned to your study. And in that SharePoint, you’re going to work with the data manager to help develop your cohort, have the views and tables pulled for the data that you’ve been approved for, and at that point then you can access VINCI and go in and look at your SQL database and the data that you’re approved for. Again, I do want to point out you will need someone, at least someone on your team that knows SQL and can manipulate the data as well as analyze it.
We do have several resources out there. These are available only on the VA intranet. We have a new VINCI central website that we have put together that gives pretty much anything and everything you need to find out, anything from data sources to how to submit to your IRB and have different boilerplate wording for security descriptions and IRB descriptions, things about submitting your DART request, the DART review process, an overview, the data request approval of, you know, what happens next, and lots of different links and resources as well as what we have the VINCI Tube and VINCI University which has our Cyberseminars as well as different what we call VINCI data, or what was it? Nuggets that you can look at for a couple minutes of okay, how do I do this, and it’s just a quick little blurb on how to do things.
The DART VHA Data Portal is also shown here. This is where you’re going to find all of your forms that you are going to need in addition to your IRB approval, your R&D approval, HIPAA waivers, protocol, and so on. And then CDW has a site for metadata documentation on data sources itself. And so I encourage you to go out there and take a look at what the data is available and what domains are available. And another place to look for that documentation is VIReC. And VIReC has some great documentation as well on the different domains and it breaks it down into, you know, the different events that you’re going to see and things like that. So there’s some great resources to go to and take a look at. Again, if you have questions on any of these things certainly do contact us.
And that takes us to the end of the Cyberseminar here. At this point I’m sure we’ve got a lot of questions. I’m here to answer as many questions as possible and then you can always contact us at [e-mail] for further assistance.
Moderator: Thank you, Ron. We do have a few questions. First of all, might I suggest you go back one slide so that people can copy down those links if they need to while we’re answering questions.
Ron Simpson: Sure.
Moderator: The first question, you were right around slide 16, 17, 18, and the person asks where do you find the last two documents?
Ron Simpson: The IRB, it sounds like the informed consent and the HIPAA waiver.
Moderator: I believe so. You were in the IRB research studies demo.
Ron Simpson: Yup. That would be the DART, VHA Data Portal will have the HIPAA waiver, and the informed consent will come from, I’d have to look at that. That’s something I can answer offline. But yeah, most of the forms you are going to need are going to be on that data portal site.
Moderator: Okay, thank you. Next question. Do you have something else you wanted to say?
Ron Simpson: Oh, basically the IRB will be able to have the informed consent as far as the form goes. I had someone come out and talk with me. Sorry about that.
Moderator: The next question is how often must the Vital Status Rules of Behavior document be updated? Must the participant complete a new one for each project he or she is on? Thanks.
Ron Simpson: Yes, for each specific study that you’re on with a specific IRB approval you will need to upload the Vital Status Rules of Behavior form.
Moderator: Thank you. When these DART memos are created, why are most of the forms I am sent printed manually, signed, scanned, and then sent for additional signatures?
Ron Simpson: Could you repeat that again, Rob?
Moderator: Sorry, I think this person is troubled by the fact that the forms have to printed out and then signed and then scanned.
Ron Simpson: Oh, okay. They can be electronically signed by sending them through email to the different people that need to actually do the signing. So there’s two ways to do it. You can either have it electronically signed or you can basically print it out, have wet signatures on there, and then scan it back into your computer. So it pretty much depends on the easiest way that you can get the signatures in the fastest approval time.
Moderator: Great. Thank you. We have a number of questions more, but I want to remind the audience that we still have about 20 minutes left, so if you have questions, please do send them in. And the next question is do I have to wait until I have R&D and IRB approval before creating a DART? What if I need help figuring out what data I need?
Ron Simpson: Okay, so you do not have to wait for the IRB approval letters completely. You can start a DART request at any time. There will be some information, obviously, that you can’t put into the DART submit, you know, the DART request itself, but you can always go back to it. So yes, so you can start a DART at any point, and then as far as if you need help with, you know, what data to request, obviously you want to go out and take a look at these different sources from CDW and VIReC, but we also have a service where you can email us at [e-mail] and ask for what’s called a Data Needs Assessment and explain what your study is looking to do. Any protocol and aims that you have would be helpful to that team so that they can help you with what data you actually are going to request.
Moderator: Thank you. How does DART approval differ from NDS authorization?
Ron Simpson: Essentially it’s the same thing. DART itself is the portal basically to be able to request all of the data, and then once it’s submitted that submission goes to NDS, National Data Systems, and so at that point it’s in National Data Systems hands to go through the approval process.
Moderator: Okay, this question is about the recorded session. How skilled in SQL does your team member need to be? Beginner, intermediate, expert?
Ron Simpson: I would say intermediate to expert. All of your data is going to come in SQL views. So if you don’t know SQL, it’s going to be relatively difficult to get the actual data down into, say, like an Excel spreadsheet that’s, you know, that’s useable for other team members. So it’s imperative that you have someone that knows SQL pretty well.
Moderator: This is our last question. Oh, one more came in. You might have said this, but I missed it, is this revised DART available already?
Ron Simpson: Yes. This is live and has been for over a month or two. So yes, our new DART 4.0 is live and ready to go for you.
Moderator: Thank you. This final question, so far, asks why was the SAS option removed?
Ron Simpson: That’s a good question. I know that you can, the SAS format was changed into SQL, and that’s the main database that everything is used for. However, I know that you can work still with SAS with the SQL data. We do have a user guide out there that will allow you to do so. So if you’re more familiar with SAS you can certainly utilize the two together, and that information can be found on our VINCI central website.
Moderator: One more question came in while you were answering that one. Any chance that I can group my Prep to Research requests? I help multiple PIs retrieve data, and it would be easier if I could keep them in the same database.
Ron Simpson: No. Each Prep to Research submission needs to be separate so that it’s pertaining only to the data that you’ve requested through DART portal, so they actually can’t be combined, unfortunately.
Moderator: Right now those are all the questions that we have for you. There’s a couple here that I need to answer. Oh, I was wrong. Regarding the question on expert level SQL skills, is this a concern? Please investigate using VINCI OMOP, it’s thought to be much easier to learn to use.
Ron Simpson: Yes, we do have an OMOP option for some of the data that comes from CDW. We actually do have an OMOP Users Group on the VA Pulse as well as an OMOP Concierge Help Desk that we could refer you to for specific questions on the OMOP data.
Moderator: Ron, at this time those are all the questions that you have. Do you have any final tips or closing comments that you’d like to make at this time?
Ron Simpson: Well, I thank everybody for attending. I don’t really have a whole lot more right now on this. If you do have specific questions and do need help with a DART submission, please do contact us at [e-mail], and I’ll be more than happy to help with that. And that that point, other than that, I guess I am pretty much done.
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