WEBVTT 1 00:00:31.470 --> 00:00:37.500 For joining today. Today we're going to start the 19 are to release webinar. 2 00:00:40.680 --> 00:00:47.340 My name is Sharon land. I'm going to be the presenter today and I'm the principal Product Manager here at Walt CMS. 3 00:00:50.220 --> 00:01:07.830 This is our product team. These of this product team here is responsible for all the features that you see here in 19 are to Tony size is going to help with my Q AMP. A so he's gonna be monitoring all the questions Mohammed will be on the call to to help if we have any coding questions. 4 00:01:10.260 --> 00:01:25.470 And I want to find out that this presentation is only the outline divas general direction is only for informational purposes and is not intended to be any form of a contract. So the features are released at the sole discretion of Viva timeline. 5 00:01:28.950 --> 00:01:40.410 Also the content of this presentation is subject to change. Prior to the 19 are to release. So please always review the help section for latest information about the release. 6 00:01:43.680 --> 00:01:56.280 We want you to interact with us, and we encourage you to ask question Tony will be monitoring the questions, so please continue to ask questions and then we'll have a Q AMP a section at the end of the presentation. 7 00:01:59.250 --> 00:02:09.660 So last year we announced that we were going to expand wall etc into a complete clinical data management solution and that included etc coding and data workbench. 8 00:02:10.260 --> 00:02:28.650 They don't work benches, the repository that will help clean and manage all your study data. So it's not just etc but it will also include IE pro labs randomization imaging and so forth. So for enterprise accounts, you may be using five to seven different applications for your wall. 9 00:02:30.000 --> 00:02:47.340 But what would we recommend is that you can move on to the wall CMS sweet and then you'll be able to save money toward data integration costs because that will be lowered what etc and Lot coding are available today. Beta workbench will be available in early 2020 10 00:02:50.490 --> 00:03:01.050 Walt has three releases a year and the releases are April August and December and this is going to be our 19 are to believe that's happening in August. 11 00:03:04.200 --> 00:03:20.580 So this is a release calendar and so important dates to remember is Monday the 22nd. That's when the pre release will be available on Tuesday, the 23rd validation docs are available and then everyone goes live on Friday, August 9 12 00:03:23.940 --> 00:03:36.960 So in the pre release environment on the 22nd. This is what you're going to see when you log in. There will be a clone of the production in the UAE environment. That means all your data and configuration be copied on 13 00:03:37.410 --> 00:03:53.730 The users are not copied on to the production pre release environment. And so, please contact your project manager so that you can add users to your pre release environment. The environment will be available up to four weeks after the 19 are to upgrade. 14 00:03:56.820 --> 00:04:08.190 So on the 23rd your validation documents will be available and to get access to that you need to contact me the support to get login credentials and then you can access all of these docs. 15 00:04:11.250 --> 00:04:32.910 So Friday, August 9 is our go live date. So that means everyone will be on the 19th are to release all the customers. Also the upgraded the EU starts at two o'clock Pacific time and in a pack in US starts at 5pm Pacific time and the upgrade may take up to six hours. 16 00:04:36.540 --> 00:04:49.710 So all these resources that are talked about these important dates FAQs about the pre release the impact assessment, what's new in 19 are to all these resources are available in our CMS Help section. 17 00:04:53.850 --> 00:04:59.040 So this is the agenda for today I'm going to talk about the investments that we made in CMS. 18 00:04:59.760 --> 00:05:06.930 The nature are two features, how that was a value add to our customers. I'm gonna go to talk about the site features do a demo. 19 00:05:07.290 --> 00:05:22.080 The features that were related to Siri and beta manager and I'm going to do a demo on that and then coder and then do a demo on that the final section after the presentations in a demo is our Q AMP a section and Tony's going to help with that. 20 00:05:23.730 --> 00:05:25.110 So let's go ahead and get started. 21 00:05:27.030 --> 00:05:33.600 So for 19 are two we've made a lot of investments in different areas to advance the CMS application. 22 00:05:34.140 --> 00:05:47.520 I'm going to go into detail later about what what what we've done for sites for series for data managers and for coders, but I want to spend some time about admin and study designer, because we did make a lot of investments in that 23 00:05:48.210 --> 00:05:56.910 Now you'll be able to configure a customized review plan and then assign that review plan to flights and case books. 24 00:05:57.540 --> 00:06:04.470 We've also created this new slick user interface for creating customized study roles. 25 00:06:05.160 --> 00:06:19.410 Also, if you have subjects that transfer from one site to another site due to relocation that will also be available. The coding configurations. You can configure coating on yourself now from us as a study designer. 26 00:06:20.640 --> 00:06:33.150 But we also made investments in a feature. So we've created the foundation so that we will be able to release in the next couple releases clinical assessment quick buttons deployment and data workbench. 27 00:06:36.150 --> 00:06:46.770 So now I want to talk about what we've done to add value to 19 are too we've optimized our user experience. We provide a feature so help clean your data. 28 00:06:47.160 --> 00:06:59.220 We make data more accessible more targeted and more focused we improved our performance and we made some improvements, our dictionary search and we provided some better reporting. 29 00:07:02.430 --> 00:07:14.490 We've also simple flied our user road management and we made some capabilities, where you can do instantaneous study changes faster site setup and the faster study bill. 30 00:07:17.730 --> 00:07:23.010 So I want to talk about how our application works and how the features, how we access that 31 00:07:23.400 --> 00:07:30.870 So we have different tabs in the application and in our data entry tab. That's where the sites will go in and enter all their 32 00:07:31.320 --> 00:07:49.290 Data collection about the clinic for our Reviews tab. This is where all the reviews happen for our series and data manager, our coding tab. This is where a coding takes place. If you're an admin, you go into a section called etc tools and for study designers, they go into our study tab. 33 00:07:53.130 --> 00:08:03.450 So before I go forward and talk about the individual features and my talk about the features. What you're going to see on the upper right hand corner. Are these icons. 34 00:08:03.810 --> 00:08:15.240 And when you see these icons. This is what it means for each of the features. If you see a thumbs up. That's auto on that means when we go live on 90 are two, you're going to see that feature. 35 00:08:15.690 --> 00:08:27.360 If you see this configuration icon on the upper left hand corner. That means that it requires some type of configuration. So if you don't see it. That means that it needs to be configured. 36 00:08:27.960 --> 00:08:37.980 And then we also have this support icon and that means you need to call support and what we call it, we turn it on the wall level and for my needs to turn it on for your study itself. 37 00:08:41.310 --> 00:08:47.580 And I'm going to go ahead and talk about what are the site's going to see when 19 are two is available. 38 00:08:50.550 --> 00:08:59.970 So the first thing that we've done is we've added this feature called Casebook confirmation users can be able to confirm if they want to create a case book. 39 00:09:00.270 --> 00:09:10.650 So what was happening is sites may accidentally create case books. So we want to make sure that this is what they want to do and will help minimize that error by asking for this confirmation 40 00:09:13.860 --> 00:09:27.900 We've also added the capability to delete subjects. But you have to be granted permission. So as you can see, this is configurable. If you have the capability that means somebody assigned you that permission that you're able to do so. 41 00:09:28.320 --> 00:09:33.540 This will give the swipes that story to correct any mistakes. They've made by adding a subject. 42 00:09:34.260 --> 00:09:46.740 But there are considerations that you have to think about when you're deleting a subject. You can only delete a subject. If it has no data and it does have data, you have to delete the data first before you can delete the subject. 43 00:09:47.280 --> 00:09:51.150 And this is only available in our new 19 our to security model. 44 00:09:54.570 --> 00:10:06.000 We also allow unknown time. So previously, current or say currently what we do now is you can enter or configure and unknown months and day 45 00:10:06.360 --> 00:10:15.510 And now you can also configure it so that you don't have to enter time. You can put a question mark in the time section and this is 46 00:10:16.410 --> 00:10:25.200 Beneficial because patients sometimes don't remember when they have headaches and they require a question mark in there and sort of making it some inaccurate time 47 00:10:28.800 --> 00:10:44.550 So we've also introduced this tabular data view where you see columns and rows for repeating item groups. So this is a nice view to have. So for example, if you have a form that's a medical history or physical exam. This tabular view is my society. 48 00:10:45.450 --> 00:10:55.890 So what we've just talked about all the features that the sites are going to see some nightmares. Go ahead and demo it live. So let me pause this for one second while I get this environment setup. 49 00:11:30.270 --> 00:11:35.220 Okay, so you should be able to see my screen. So I'm logged in as a fear see right now. 50 00:11:36.780 --> 00:11:47.550 And if I click on new case book, what will happen is now that I get a confirmation and it asks do you are you sure you want to create this new Facebook. I click continue. 51 00:11:50.220 --> 00:11:58.440 And then it creates a new case for. So now what I made a mistake. So now I have that permission, I can go ahead and delete it. 52 00:11:58.770 --> 00:12:11.430 So you see this new area right here where it says delete subject, and you have to be granted his permission before you can go ahead and delete it. So I'm gonna go ahead and delete this subject, I'm gonna have to put a reason why 53 00:12:12.660 --> 00:12:14.130 And I click on Continue. 54 00:12:15.600 --> 00:12:17.070 And that case book is gone. 55 00:12:18.480 --> 00:12:22.170 So the next thing I want to show you is that unknown time 56 00:12:25.620 --> 00:12:28.620 So let's say I'm not sure of the time. 57 00:12:30.750 --> 00:12:33.090 And going here. 58 00:12:46.680 --> 00:12:58.740 And I go in here and edit this form. And you know what, I made a mistake and I received additional information and they really didn't know the time. Now I can go in here and add a question mark. 59 00:13:00.780 --> 00:13:06.180 And then go ahead and save it. So now we allow for unknown time 60 00:13:07.890 --> 00:13:11.130 So last thing I want to show you is that tabular view. 61 00:13:18.390 --> 00:13:35.070 And so I have a physical exam for right here and it shows the view in this tabular format, whereas columns and rows. I can see the open queries. I can see respond to queries. If I click into it. I can also access my audit trail. 62 00:13:36.450 --> 00:13:50.130 And I can also see if the data has changed. So these are things that your sites will be able to see when we, when we release 19 are too. So I'm going to stop the demo. And I'm going to continue on to our presentation. 63 00:14:01.320 --> 00:14:13.770 Okay, so when we thought about is the trades. What's the site's going to see when 19 are two comes out. And now let's talk about the furious and data manager, what's the benefit that they're going to see when gets released 64 00:14:17.550 --> 00:14:28.050 So the first thing is we've made data more accessible. So when you go into our review user interface that new review tab, you're going to see these new columns that were added. 65 00:14:28.290 --> 00:14:39.090 Their last event and next event so shows when the last visit is the next visit. We've also we've also added a case book version so you can see what kids book version is on 66 00:14:42.300 --> 00:14:54.330 We've enhanced our user experience so that when you're navigating on that tree on that visit informed and you're and you're rolling and scrolling down the right form side it will 67 00:14:54.750 --> 00:15:10.500 It will be in sync right now and the left side will be highlighted. We're also allowing for form level reviews. We've also made intuitive icon changes. And we've also made that pop up screen when you view as a site, you can see that information, a lot better now. 68 00:15:14.460 --> 00:15:22.860 We've also added a Save button. So any changes that you've done to the STV and a dear, dear Mr. It must be saved. 69 00:15:23.400 --> 00:15:41.820 So this change happen because what we were seeing that if somebody clicks that check marks on the right hand too fast. It was sinking in appropriately for the statuses on the left hand side. So now you have to make those changes to the FTP or the EMR and you must click Save. 70 00:15:45.900 --> 00:15:54.330 So I do want to talk briefly about that new review tab. So in 19 our one we released a new room of review tab. 71 00:15:55.530 --> 00:16:08.070 And for traditional etc reviews for done on his era and Eva thought like, Well, what if we designed the user interface from scratch and made it specifically for series and data manager. 72 00:16:08.460 --> 00:16:19.110 This is how the review tab was born. And it's consistent with Vivas culture of innovation. We want to do something that was specifically beneficial to our series and data manager. 73 00:16:19.500 --> 00:16:28.380 So why would you use it because it's a more comprehensive view and focusing on reviews and instead of designing it for site entry. 74 00:16:29.010 --> 00:16:36.600 You can easily navigate to the visit informs there's a centralized location for all your queries and reviews. 75 00:16:37.080 --> 00:16:54.750 I'm going to show you that you can filter and you could show only the things that needs to be done and I can easily toggle between a site view and a monitor view. So if I'm not comfortable seeing from my view what data entry or MTV may look like I can switch to the site view. 76 00:16:56.820 --> 00:17:01.860 So I'm going to go ahead and start the demo. So let me pause while I get that environment. 77 00:17:34.620 --> 00:17:40.980 Okay, so I've logged on as a data manager and I'm going to go Access the site. 78 00:17:44.070 --> 00:17:59.340 maximize my screen here. So what we've added here is this last event and this new event, I can go in here and hover and I, we've added that case book virgin. So we've made data more accessible. So once I click in here. 79 00:18:00.900 --> 00:18:14.760 What you will see in this left. Now we made changes here. So these icons. These are status icons and before it made of look like it might be more clickable. So we've changed it to make it look more like status icons. 80 00:18:15.300 --> 00:18:27.990 And so these cities have circles. That means work has not been done our half circles right here. That means that the work is incomplete these empty circles mean and it was not done. And these check marks mean that they were completely done 81 00:18:29.280 --> 00:18:36.630 So if I want to come in today. And I want to just focus on the things that I need to do today. I can go ahead and click on this filter. 82 00:18:37.470 --> 00:18:52.920 And you can see that the substance form went away because those forms were completed so any form that was completed, I can go ahead and just change that to that view. So it makes me focus on the things that I need to do today. 83 00:18:54.660 --> 00:18:56.910 See, other things that we've added 84 00:18:58.770 --> 00:19:17.940 There is this form capability right now that I can go ahead and review it at the form level. So if I click on here, you see all the changes that are made on here and at the same time as you can see anything that was not saved is now highlighted in yellow. 85 00:19:20.490 --> 00:19:26.700 So another nice thing that we've done here is that when I go in here and I start scrolling down 86 00:19:28.710 --> 00:19:37.860 You can see on the left hand side. So right now, you'll see that the demographics and physical exam or the darker blue and then when I start scrolling. 87 00:19:38.370 --> 00:19:50.400 I go to the next form, it changes. So we meet the navigation so that it will sync. So as you're scrolling it coincides with what you're seeing on the left hand side. 88 00:19:51.900 --> 00:20:06.420 These icons have also changed to make it noticeable that they are clickable. So if I want to go see once my Where's my next Open query. I click on that, it brings me to that query itself. I could go ahead and close that queries. 89 00:20:06.870 --> 00:20:11.280 If I want to see where the next responded queries. I click on that. 90 00:20:12.480 --> 00:20:22.710 I can also go in here and say what you know what I clicked on here. I'm going to go ahead and make sure that all of this is safe. 91 00:20:32.640 --> 00:20:41.550 And as you can see, once I do those updates, what happens here. It gets updated here. So I'm gonna go ahead and show you that again. If I click on save. 92 00:20:42.570 --> 00:20:56.340 That and I click on save all of this is upgraded for our demographics, so I can also go in here and check this task filter and it was showing me all the tasks that I need to do as my EMR. 93 00:20:58.290 --> 00:21:09.060 So this view right here is really nice. And we specifically designed it for our series and data manager. So I encourage you to use this review tab. 94 00:21:09.390 --> 00:21:20.580 Instead of the data entries that was made for sites. And if you do not see this review tab, please call your support and then we can turn that off for your wall. 95 00:21:21.660 --> 00:21:30.330 So those are the features that we've done for our series and data managers. And now I'm going to go back to my presentation. So let me pause for a second. 96 00:21:49.800 --> 00:21:57.780 Okay, so now I'm going to go ahead and go and talk about coding. Right. So what did we do for coding in 19 are two 97 00:21:59.850 --> 00:22:13.380 So the first thing we've done is we've enhanced a user experience coders can select or deselect coding items in the coding listings panel. We've also moved the summary and this exposed or an icon to provide a cleaner look. 98 00:22:16.380 --> 00:22:25.500 We've added a query status filter so that if I want to focus on the task at hand. I only want to see open queries or respond to queries. 99 00:22:28.500 --> 00:22:46.410 I've also need the dictionary search more efficient. So when I'm searching for a drug name, but they have different preferred names all those will be grouped together on the top. I can search up to 10 keywords and I can, it can also now support special ASCII characters. 100 00:22:49.290 --> 00:22:55.920 We've also added a dashboard that provides a graphical visualization of recording status and progress. 101 00:22:58.800 --> 00:23:01.950 And we've also added a unique term report. 102 00:23:02.970 --> 00:23:14.970 So those are the features that we've added for 19 RT for coding, but I'm going to go ahead and talk about the unique terms report. So, this report, you do have to call support to be able to get this report. 103 00:23:15.420 --> 00:23:22.650 And what you're going to do is you can select the data rage and if you can see here that Asterix under the new term. 104 00:23:23.130 --> 00:23:39.000 If there's an asteroid. That means that there was a new item that was flagged and it should be reviewed it is grouped by each unique term. So you see the record count for the each unique term. And we've also added a column where you can go ahead and add your comments. 105 00:23:41.190 --> 00:23:45.930 So now I'm going to go into a live demo and then a pause and and get into the environment. 106 00:24:07.320 --> 00:24:17.610 Okay, so I am login as a coder right now. And the first thing I'm going to show you is this select and D, select this is helpful. So let's say search on Advil 107 00:24:19.050 --> 00:24:29.580 And instead of me clicking one at a time. I can now select all, and that gives me the convenience of not selecting one at a time. So I'm gonna go ahead and clear that 108 00:24:31.860 --> 00:24:47.280 And I now want to be able to see you want, show me all my open queries. If I click on that, it will show only my open queries. So these are all options that I could choose from for the queries. So we've introduced a new query filter. 109 00:24:50.310 --> 00:25:04.080 And now this section right here, this little IRA. Here we moved in our summary section to be over here. So if you want to see information about the form or about what therapeutic area. You just highlight this icon. 110 00:25:05.850 --> 00:25:13.170 So now I'm going to go into the dictionary search. So, you know, you've used this yet, but this is nice. I can make this screen a lot bigger. 111 00:25:14.520 --> 00:25:21.210 So I'm going to go into my dictionary surgeons talk about efficiencies that we've done here. If I enter light, a key. 112 00:25:22.680 --> 00:25:24.990 And I do a search principle that right 113 00:25:26.220 --> 00:25:32.820 Yes, I did. And it will include all the different preferred names group together on the top. 114 00:25:34.710 --> 00:25:40.590 To know I'm going to show you. I'm going to cheat a little bit. I've been to a cut and paste and I want to show you 115 00:25:42.870 --> 00:25:50.850 The searching you do any type of ASCII characters. So in here, you see I have dashes and I have period. 116 00:25:53.010 --> 00:25:54.780 So I do a copy here. 117 00:25:56.130 --> 00:25:57.090 I'm going to do a piece 118 00:26:03.090 --> 00:26:04.350 And when I do a search 119 00:26:07.110 --> 00:26:11.220 It searches and it reads that there are periods and there are dashes. 120 00:26:11.670 --> 00:26:27.000 In the current release it will throw and let you know an error that hey, we don't recognize that character. So now we support these ASCII characters. And I also want to show you that pen keyword term search. Let me go ahead and get that screen. 121 00:26:29.340 --> 00:26:30.840 So here are 122 00:26:32.070 --> 00:26:35.790 10 terms you go ahead and paste this 123 00:26:42.150 --> 00:26:45.000 And add it in here for search 124 00:26:47.520 --> 00:26:49.410 And now go ahead and search that 125 00:26:52.140 --> 00:26:57.810 For now, and added all these results because I can support the 10 key terms search 126 00:26:58.620 --> 00:27:20.280 So that concludes the demos for series for data manager for coding and site. So these are all the features, you're going to see when 19 are two becomes available in August. Now we're going to go to our Q AMP. A and I'm going to ask Tony you pause for a second again. 127 00:27:23.520 --> 00:27:34.590 Hey, Sharon. There is one question so far. So the question is what happens to the subject numbering. If you delete a subject is the subject number reusable. 128 00:27:35.190 --> 00:27:47.370 One of the other subjects created before the mistaken subject is deleted. And the answer to that is that the subject number right now is is not reusable, so it will skip on to the next subject number 129 00:27:49.830 --> 00:28:07.290 And and in the situation where, let's say you have, you know, if you're using or kind of default screening ID. If you're creating subjects like you know you have centers, one through 12345 and you deleted three. The next subject will be SCR 0006 130 00:28:08.550 --> 00:28:17.880 However, if you're using a manual subject naming kind of override that will then override whatever that that that screening number that you have 131 00:28:20.730 --> 00:28:28.890 This is a follow up question there. How does someone find a deleted subject and an audit trail. So there is a audit trail report. 132 00:28:29.670 --> 00:28:41.100 That you can generate through a the audit trail job and that that's triggered in etc tools and in there, you will have a file for all deleted subjects. 133 00:28:41.910 --> 00:28:55.440 So there, there's a in that job. It will create a individuals CSV file for every subject in the system with a full audit and they will also create a file for the deleted subject. 134 00:28:55.950 --> 00:29:05.250 And and they'll preface the the naming of that that file with deleted and then subject ID study name site name and subjugating 135 00:29:07.290 --> 00:29:11.550 And that that particular file will contain the full audit of that deleted subject. 136 00:29:14.940 --> 00:29:18.180 Thank you, Tony. Is there any more questions. 137 00:29:30.390 --> 00:29:32.880 I don't think we have another question, Tony. 138 00:29:34.080 --> 00:29:34.170 Oh, 139 00:29:34.860 --> 00:29:36.180 Yeah, another one just 140 00:29:36.180 --> 00:29:36.990 Came in 141 00:29:37.050 --> 00:29:53.400 Okay. The question is, his ability to lock data before the PII signs still being considered as a future update I asked because we have a recent case of a seer see deleting data, they should not have 142 00:29:55.110 --> 00:30:11.220 So now, hold on, let me read the ability to lock EAT IT BEFORE THE P I said okay so the answer is, is no, because the lock will prevent any type of activities. However, if you freeze the data. 143 00:30:12.090 --> 00:30:21.450 Before before signature that should prevent the the CRC from deleting any of the data. So if you freeze all the 144 00:30:21.480 --> 00:30:23.550 All the forms or freeze entire Casebook 145 00:30:24.090 --> 00:30:27.330 They won't be able to delete. However, they could still go inside. 146 00:30:31.710 --> 00:30:34.800 Thanks, Tony. Is there any other question. 147 00:30:44.700 --> 00:30:46.830 Okay. Well, I think that's it. 148 00:30:48.060 --> 00:30:55.980 Thank you everyone for joining. Thank you for being a valued Viva customer. And this concludes our 149 00:30:57.270 --> 00:30:58.890 Presentation. Thank you.