Electronic Trip Reports in Siebel Clinical (CTMS)

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Electronic Trip Reports in Siebel Clinical (CTMS)

Good morning everyone. I would like to welcome you to BioPharm’s 6th webinar in our series of CTMS webinars. And today’s webinar we’ll be focusing on the completion and approval of electronic trip reports. And in case you missed any of our previous webinars or you would like to watch them again, the recorded presentations are available for download from the website. www.BioPharm.com We’ve covered a variety of topics, in our past webinars and have some interesting topics coming up as well, in future months. And if you do have some ideas of topics that you would like to see us present, please go ahead and send us an email and then at the end of the presentation, you’ll see my email address where can send that Let me start by introducing myself. My name is Param Singh, I’m the Vice President of the clinical trial management solutions process here at BioPharm Systems. I’ve been working in the health and life science industries since 1999, and have almost exclusively been working with Siebel Clinical during that time Before joining BioPharm, little over 3 ½ years ago, I was part of Accenture Pharma R & D Practice and leading Siebel’s CTMS implementations there as well. And overall, I’ve been a part of about 15 implementations of Siebel Clinical now and these vary from implementations for pharma CRO, medical device companies and also range from anywhere from 30 users to global implementations of over 4,500 users. In each type of and size of organization has its own approach to selecting and implementing their solution So here’s today’s agenda. We’re going to start with a brief look at the components of final reports which are called Trip reports in Siebel And then we’re going to look at 4 common challenges associated with completing trips reports electronically And for each challenge, we’ll discuss the ways in which Siebel Clinical Vanilla and BioPharm’s pre-configured ASCEND version of Siebel Clinical addresses these challenges And we going to knock off with a live demonstration of completing and approving an electronic trip report in ASCEND. And then we’ll have some time for questions Before we do get started, I do want to point out a few features of the meeting platform that we are using. Right now, we have everyone else on mute, so if you do have an issue, please click on the raise hand button on your screen, and we’ll pause and address the issue, if you’re having any. Also, for the question and answer portions, feel free to submit questions via the chat function on your screen. As we progress during the webinar, you can submit your questions at any time and those questions will come directly to me and I’ll address them during the Q&A Session. If you would like ask questions live, you can press, I think it is star 7 on your line and then once the question is asked, you can press star 6 to mute your line again. I also want to remind everybody that we are recording this presentation and we will post it on our website after today. Let’s get started So, first, like I said, we want to start out with basic typical components of our Trip Report. So, the first one here is the site visit information. This is some basic information about the site and the site visit, the dates and just relating it back to site and the PI and the attendees that are at the site The next item is checklist items, so questions or tasks that you need to do on the trip report Your narrative questions, questions that require certain descriptive answers, Your follow up items, your issues that you encountered during monitoring at the site and additionally for monitoring visits, you’re also going to be looking at subject enrollment statistics, monitored serious adverse event, monitored the protocol deviations and CRFs as well So, for all trip reports, you’re going to look at the first four components for initiation, evaluation, for monitoring it and close out And for monitoring and close-out visits, you also look at these four sub-routes that are listed as well. And we’ll look at each of

these in a little bit more detail on the next few slides So your site visit information on your Trip Report, this is basically your basic facts that need to be captured on the trip report at your site. So your protocol, your site number, Your Primary Investigator, some dates you know as to when it occurred, when it ended, and possibly the names of the attendees beside the site personnel that was present at the trip. And these are just some background information or details about the site visit Your next piece, or your next component of your trip report, is going to be your checklist items. These are the specific tasks that need to be done during the visit and that can be answered with a yes/no or not applicable answer And these are some of the examples of checklist items. And you know, site staff training records are current. Your site regulatory binder is complete, You’ve captured informed consent for all the subjects that are on this particular site. All these are checklist items that basically the monitor is going to check off whether these occurred or not. And as part of your business process, walk through custom configuration in your system, If a monitor is answering no to any one of these questions, then you can actually enforce a, you know, further comments. If a no answer is given to any one of these, these items. And this may be very similar to your, you know, site monitoring SOPs that are in place and we’ll look at this in a little bit more detail and how it relates to your SOPs as well The next component of your Trip Report may be narrative questions. So these are similar to your checklist questions but they actually require a narrative or descriptive answer from the monitor. So examples of these would be How would you describe the site’s compliance with the Informed Consent Policy? How would you describe the site’s compliance with the drug accountability procedure? These questions require more narrative response by the monitor and are not simply just, just a checklist to go down Next, you’ll have follow-up items. These are actions that a site must take usually due to a finding during a site visit, but not always. So you can actually capture follow-up items or issues when they get to the site And in time, But during your site visit is when you follow-up on what’s happened or what actions have been taken and whether these follow-up items or issue have been closed Some of these follow-up items may be that the Sub-Index requires training in product handling. Or we need to obtain CDA for a new staff nurse. We have no internet access available and we require that for this particular study, and issues or items that need to be captured and tracked through closure of these sites will be captured in this follow-up items section So, you’ll need to track these from when we identify the issue through when we close out this issue, and make sure that nothing falls through the cracks And for monitoring visits. So, monitoring and close-out visits. We’ll also need to track these additional items. So, the first thing is your enrollment statistics at the time of that site visit. So this is an important one where you track the number of screened, enrolled, completed and discontinued patients at the time of that site visit. So you capture a true snap shot of the enrollment statistics at the time of the visit Your Serious Adverse Events. Some organizations do like to monitor serious adverse events You know, how many serious adverse events have we, you know, have we monitored at the site which subjects related to, basic information about these serious adverse events that have occurred at the site during the trial Protocol deviations. Those are also something that certain clients want to pull into their Trip Reports as well. Basically, a protocol deviations log of any and all protocol deviations that have and violations that have happened

on this particular site as it relates to either patient or site procedures And then last, but not least, Monitored case report forms. So, to be able to identify which CRF with your pages and related to which visits and which subjects are monitored during each site visit. These are some of the things that we’ll want to capture in routine monitoring Trip Reports. So those are the four main components of our Trip Report What I’d like to talk about now is some challenges, there some specific common challenges that we see in our client’s face, when looking at electronic Trip Report tracking within a system. The first one is adhering to site visit SOPs. So how do we enable our site, how do we enable a system rather to adhere to our company’s SOPs as it pertains to site visits? The next one is capturing a snap shot in time for when the site visit occurred Next is track the report throughout the review process. As the Trip Reports are reviewed, how do we track reports through that process? And finally, recording approvals for the Trip Report The next three slides, we are going to discuss how Siebel Clinical Vanilla and our ASCEND configurations address each of these challenges And then we’ll walk through the demo itself So the first thing, is adherence to SOPs Siebel addresses the challenges of ensuring that Trip Reports adhere to the governing SOPs through template functionality. A template is kind of like an outline or basically, a set of tasks that are standardized within the system. It allows you to create sort of a blank forms that monitors can fill out each time they visit a site. So, within a system, the template for Siebel Clinical typically is set up to mirror your SOPs. And then the only way our monitor can Complete a Trip Report in Siebel is to use one of those templates So, you’re enabling your SOPs within the system and allowing monitors to follow a standard process with the use of those templates. This functionality ensures adherence to SOPs and consistency across all of your site visits reports To demonstrate how a Trip Report template can be set up to mirror an SOP or an SOP, here is a portion of a sample monitoring visit SOP. So, you can see that there are two sections: the first section is basically one about regulatory binders and one about study products. And you can see that there’s some items basically set up like checklist items that we’re trying to ensure the client protocol and protocol amendments are at the site, approved current and form consent templates are the approval documents, et cetera So, when we look at this, we can directly translate this into a Trip Report template within the system. So this slide basically shows that what we’ve done in the system is basically translate that SOP for each of the items that we’re study, document, regulatory binder related, we have converted those into checklist items. And each of those items that we mentioned and that are mentioned in that SOP are available here. And the specific question that were designed as narratives, we’ve also included those in here under device accountability There’s specific questions that are setup in our template here as well During the live demo, We’ll actually show you how this gets applied. So once you set this up, since your SOPs are laid out in this fashion, you can easily trig with that into a Trip Report template within the system And once that is setup that’s a global template for all of our studies and sites to use. And we’ll look at in the live demo how that gets applied to this site like this Another common challenge associated with Trip

Reports is the need to have your report reflect a snap shot in time. You know this is easy to do with paper reports, because we can generate a report and go back to it and look at what the current or the status of that particular site was at that time. But, it becomes trickier when we’re talking about electronic reports and records in a system. Because all of those records are live in essence. For example, follow-up items. You know if we open up a follow-up item and then we track to the closure, we’ll actually updating that record as we go along. So somehow, we need to record and track the status of those say follow-up items or protocol deviations, without needing to recreate them for each new Trip Report So, we want to able to capture the snap shot in the report but also have the capability of managing and tracking those follow-up items through closure. So in a sense, what we’ve done is created areas outside of the Trip Report where you can track all those items, ah, protocol deviations, serious adverse events, and CRF monitoring And then, within the trip report, we’ve created a way to import read-only copies of those records at specific times, so at any point when you’re importing those records into the Trip Report, it’s actually taking a copy and taking a snap shot of again, what, what is the current status of those records at that site. Again, this will become a little more clear once we jump into the demo Another common challenge is the need to track the Trip Report as it moves through its review process. So, again with paper reports, it’s easy to walk through and track rounds from desk to desk for review, but it’s trickier with electronic reports. So, what we’ve done in Siebel Clinical or what Siebel Clinical gives us is the capability of having a Trip Report status, which is governed by a state model. And what that means is that we can actually have that status field, the access to that status field can be controlled based on which users are allowed to make certain changes So, for example, a monitor can take a Trip Report status from in-progress to submitted, but that is the extent of their sort of role on changing statuses on the Trip Report. And then study managers can then take it from submitted to either rejected or approved And once it is rejected, then the monitor has the capability of changing that status from rejected to say resubmitted, for example In Siebel Clinical you have this work flow that can be tied to this status In addition to that, in a sense, what we’ve done in include a visible audit trail as well, so any time a status of a Trip Report does change we actually capture it in a visible audit trail and not only in the audit trail in the back end, we make it part of the Trip Report approval history in the Trip Report itself. So, in the actual Trip Report, when you’re printing it that audit trail history of reviews and approvals is also attached directly to the Trip Report And finally, the biggest challenge we’ve seen when it comes to electronic Trip Reports is how to ensure compliant approvals. So, there are three primary ways of approving Trip Reports or electronic Trip Reports, each with a varying degree of compliance risks The first is printed reports with ink signatures, so even though you’re using an electronic system, you can still generate a TDF or some sort of report, paper report and then again route it for wet ink signatures, and get away from electronic approvals The second is re-authenticating for status changes. If any time a status is changed within this electronic record, we ask or we require the user to re-authenticate themselves using their user name and password And the third is including a visible audit trail of status changes within the Trip Report So, that is, any time the status does change, we basically create an audit trail record and put it into the approval history of the that particular electronic record. So, that will give us a visible status history of that electronic record. How many times is has been

submitted, how many times it was rejected, and finally approve and how long that took and who made each of those specific status changes. So, ASCEND out of the box the visible audit trail is available and is a less conservative interpretation than others but some of our clients have determined that just that audit trail meets the requirements set forth by the 21 CFR part 11 guidelines In this demo, what we’re going to show you is what that audit trail looks like as well as how re-authentication can work, so both of those things, both those functionalities together have been seen by virtually everyone of our clients as fully meeting 21 CFR Part 11 compliance through through, through system functionality So now, we’re going to jump into the demo and I’m going to share my application. I’ll try to go slow, because I know there’s lag sometimes, with this plat, with any sort of meeting platform we are using, so I will try to go allow for that lag So, what we’re going to do, just on second, what we’re going to do is navigate to one of our sites and go through the whole process, process of monitoring and what a typical monitor would do. Before, running their Trip Reports, as well as, you know, after submitting it, and the whole review and approval process So I’m going to go to one of my sites. Within this site, I’m going to first look at the records that I am going to monitor. And like I mentioned before, in a sense, what we’ve done is brought some of those features outside of the Trip Report so that we can manage them so it’s like all of those items CRF tracking, adverse events, and protocol deviations. So when we look at all of those first, as it pertains to this site So under site management I’m going to go into my follow-up items and you’ll notice that there are a few follow-up items in here. And what the Trip Report, this is basically an area for us to track any sort of follow-up items at any time. So, these are not necessarily items that are only, you know, uncovered during a trip report, during a site visit. But, at any point if you identify an issue that you need to track you can, you can create a new follow-up item and let’s say it’s from, let’s do it a training one we have new site personnel, that requires training and so the status is open. We’re going to say that , we’re going to give them a couple of weeks to complete that and save that off. And, so we can enter some comments, you know, there’s a new nurse that requires study training So, this is a new follow-up item. If the follow-ups items are open, they will automatically show up on the Trip Report But if I close one of these items, I have to select to be part of the Trip Report and reason for that is if we have a series of closed items, we don’t necessarily want them to automatically to show up on the Trip Report because they might have been closed for quite some time. And if I close this regulatory binder missing, I’m going to close it and I am going to select it for the Trip Report. So, that’ s what I have to do to select anything that I have closed since the last time I, I created a site visit Moving on, I’m going to go into our protocol deviations. Protocol deviations are set up in system the same way, where they’re related directly to the site, but we have an opportunity here to have different types of protocol deviations They can be either sited related or they’re subject related. You’ll notice that if I do a study procedure protocol deviation, so they deviated from study procedure. You can make

it very generic. I don’t have to flood the training idea, you can put in some dates when we identified that, when it was identified by the monitor, identified by the site, any sort of actions required, and the status and future resolution or closure. I can fill any of these deals out just to track that protocol deviation. And again, you can have site level protocol deviations or subject level. If it is subject related, then you can actually select which subject at that site had that protocol deviation, okay Nest, there’s adverse events. Adverse events work pretty much the same way as protocol deviations, you have your, you know, you have certain fields to track the overall description of it, the event type is either adverse event or serious adverse event and then you have a series of dates of when they were, when the occurrence happened, when it was sent CAC identified by the site, et cetera. One key note here is that for adverse events the way it is setup is that only your serious adverse events are what get pulled into the Trip Report. So, event type is important to indicate which ones are serious adverse events, therefore the ones that are getting, get pulled into your Trip Report And last, but not least, we’re going to look at our CR tracking. So, CR tracking we have all of our completed and planned subject visits So, can see the subject number, the visit name, visit type and the number of CR pages So you can actually go through and let’s say I’ve we’ve gotten all of the pages, so you’ve got pages one through four and is source verified, we have source verified date, the day it was retrieved, today. And I’m going to select this one for Trip, ah for Trip Report inclusion and I’m also going to select this one as well. So those are the screening visits for both of these patients are, um, are going to be selected for the Trip Report. I’m not going to fill out all of these conditions here, but this is basically what you need to do to select which ones are, are, have been monitored So next, now that I have done my site management and my monitoring activity, I’m going to go into my site visit. So, I’m going to go into my site visit, just going to create one real quick and this is going to be uh a routine monitoring with flex site monitoring, then I’m going to click on planned visit start date to take me into my Trip Report So, right off the bat you see our site details, our visit details, Trip report details at the top. You see our current enrollment statistics, they are blank. Everything is blank, so far, you have the checklist items section, you have a questions section, follow-up items, CRF, protocol deviations and serious adverse events. And a Trip Report approval history that only has one record in it. I just created this site visit record. We we’re going to walk through. Filling this out So, right off the bat, we see our site details are already pre-populated. I’ve put in my monitoring visit information. I’m going to say the visit actually started today. And as soon as I put in a completed date, you’ll, I want you guys to looks at the current enrollment statistics, they’ll automatically get populated, based on, again, what is current at the current enrollment statistics at the time of this visit completion. So this automatically calculates that we have three screened and two enrolled patients. And none that have been early terminated or screen failed or completed et cetera. I can add in my attendees, it automatically puts in my PI here, and then next, since I’m done with my visit, now I can go to my Trip Report Details. And this is where I select my template. And, again my SOPs have been translated into my template and this is where you’re going to see that being applied to this site visit. So I select my CR demo monitoring, and you’ll notice that all of your checklist

items are now populated and are questions are populated as well So, if you remember, these are our checklist questions, so the response to these checklist questions is going to be a Yes/No not applicable or not, very standard responses. And what I’m going to is, I am going to go down this list and I can mark off those checklist items If there is a, you know, again, you can do this systematically or from a process perspective If an answer is No, then we have to put in some additional comments as to why why that is no. Why hasn’t it been done? So, I can go through this list very easily, I just go through the checklist as defined in my SOP. Then for our questions, we are, um, we’re going to look at the response and you will notice that the response field is not a drop down anymore. So this is actually, how would you describe the storage space and the conditions of the study product. The storage space is adequate. I mean it could be very lengthy descriptions. It could be a very detailed narrative for each of these questions, so our narrative response can be written in here It’s a free text field for us to be able to enter those questions in So, next, I’m going to the next section, which is import follow-up items. So, you’ll notice there’s no follow-up items in here right now, but I do have this button. And this button basically allows us, again, import a snap shot of all the relevant follow-up items that belong on the Trip Report. So as soon as I click it, it will pull in each of the ones that were opened and the one that was closed that I had selected for inclusion on our Trip Report. Okay, so, these are all read-only’s, so I can’t changed anything on, in this view I go into my monitored CRF and I import my CRFs and you’ll notice, again, both of those screening visits for those two patients have been imported and the relevant information that I added has been imported. Again, this is all read-only Import my protocol deviations all of them come through it’s a full log of your protocol deviations as it relates to this site. And then serious adverse events. Again, we had three records, but only one of them that was in that serious bracket goes in So now, as a monitor, I have completed this trip report. So, I’m ready now to, I’m ready to submit it. So what we’ve done here is created some buttons to allow for that submission So, when I submit, we have an error message, warning saying are you sure you want to change the status of this Trip Report? Because, again, these are work flows that, you know, change certain functionalities of the Trip Report, so we want to make sure that the user is wants to make that change. We hit okay. And then it gives you another warning that this is an electronic signature and it’s legally binding equivalent of physically signing the document So it’s just warning basically make sure that the user knows that they’re effective signing this electronic record. Click okay And are met with a user known dialogue, so I actually have to authenticate myself as a user, as the user, I’m going to click on go, enter my name, enter my password. As soon as I enter that, then you can see that the Trip Report’s status has been now changed to submitted So as soon as I submit this, the Trip Report, you’ll also notice that these import buttons are now no longer enabled. So, the import buttons are disabled now and so you can’t change a Trip Report as a monitor once you

have submitted it The other thing that has changed, is if we look at this Trip Report approval history, you can see that at each point when we’ve changed statuses of this particular trip report We’ve captured that approval history. You can see that when it was not started to in progress and then from in-progress to submitted Date and time stamped as to when that occurred and who made that change So now that we have approved this Trip Report, I’m going to come in and as, I’m going to pretend I’m a manager now and I’m going to review this report. Now, reviewing this report for the questions and checklist items, it becomes a little bit easier So, we have these two views, one is manage, which is what the monitor used, and I’m going to go into this review trip report which is where the manager would come in. So, the manager is going to see the same information site details, visit details, Trip Report details, we see our current enrollment statistics But here, in the Trip Report review list, we actually see the checklist items the checklist questions and the regular narrative questions in the same section. And that’s because, you know, your SOPs, basically bundle anything that is a narrative question versus a checklist question together, so this is a way to be able to see all of that together. So, you know, you can see anything that has a Yes or No response or you have questions that have a narrative response. So, all of this can be can be seen together and reviewed together And what the reviewer is going to do is we have comments that the monitor can enter, but we have reviewer comments that the manager or reviewer can enter. So reviewer comments are important, because it facilitates this back and forth for tracking that approval process and communicating what needs to be changed potentially before approval. But it doesn’t show up on the printed version of the Trip Report. Your comments are just to facilitate this back and forth from the submitter and the approver So we have reviewer comments on each of the questions. That are in this section as well as a reviewer comments at the highest level So if a manager wants to say that there’s specific things that need to be changed on this Trip Report before they approve it, they can enter that in here. So, under reviewer comments, I’m actually going to put some information and say we need additional details on follow-up items that are open. So very generic. So, you can imagine you can put it as much detail and direction as you would like in these reviewer comments. Both at the highest level as well as on this individual question level. So once you put those reviewer comments and I’m actually going to reject this Trip Report as a manager So, if I’m rejecting, again, I get this are you sure you want to reject it? I hit okay Rejection, the way that we have it configured doesn’t require reauthentication. You’re not actually signing a document by doing a rejection The only time that you’re required to do that is when you submit or when you approve So, now this Trip Report is now rejected, if I come back in here, again, I’m , if I come back in here as a monitor I can see that the Trip Report’s status is rejected and I can see why it has been rejected. I can look at the reviewer comments and see what I need to do. Additional details on the follow-up items that are open. Okay. If I go down to my follow-up items, in other areas, you’ll notice that the import function is now still, enabled again. But I can’t make any changes directly in here. I have to go back into my site, follow-up items to make any changes So, what I’m going to do is go back to my site go back to my follow-up items and that new one that, that we created, umm, I’m going to update it. So I’m going to put in some additional details, but I’m just going to in some updated text and uh, now that I’ve updated it I can go back into my Trip Report

Now, that I’m back in my Trip Report, you’ll notice that updated text is not here. So, again, this is very clearly demonstrating that this is a snap shot in time, right? So even though those follow-up items have been updated and may be closed out or you know, additional details have been added, what remains in my Trip Report is what I took as the snap shot last time I imported it So, to update this, follow-up item or CRF or anything else I changed, what I have to do is click on this import follow-up item button again. As soon as I click on that you’ll notice, again, we took another snap shot of all of our follow-up items that have been entered at the site level. And it needs that, it also looks at the criteria of those records So, if I’ve removed, and just to illustrate that, if I go back in here and go into my follow-up items and I don’t select this closed item for selection in my Trip Report. If I go back into my site visit, again that item will show up because we haven’t taken another snap shot and if I take another snap shot it will remove the ones that I didn’t select or removed from selection from this Trip Report So, This is the way that a monitor would update their Trip Report based on what the reviewer had communicated, that needs to be updated and then I’ll come back in here and resubmit it. And again, I get the same warning, you know that I am electronically signing and I’m re-authenticating the user again. And as soon as this authenticated, it’s now, the Trip Report status is resubmitted So, now, again, when you look at your Trip Report approval history you can you’ll always be able to see when was the initial submission versus how many times it was rejected and when it was resubmitted and finally approved So, if we end up rejecting this report several times, then I’m actually going to do that If I come back in here and reject it and I am just going to go through and resubmit it. And finally we will approve it And again, for approval, we get the same error messages and warning messages that we’re actually signing this document. And it will then require me to enter my user name and ooops, a good error. So the other function we put in here, the other functionality is the approver, the approving user can’t, cannot be the same as the one who last submitted the Trip Report So, that is an important feature that we put in considering all of our clients wanted that functionality. So, from a demo prospective, I can’t actually show you that approval But, what I can show you is that from the audit trail history, again you can see any time, as many times as it’s gotten rejected and resubmitted, um, how long that took. And where the issues are with the Trip Report approval that’s within your system And, the other things that we’ve added, again, just to capture certain matrixes out of your Trip Report, if we get, since capturing when the visit is complete, when the Trip Report was initially submitted and when the Trip Report if finally approved. We actually that could at this level, we’re actually going to capturing certain turnaround times as well. And, so I mean, right now all of the turnaround times are going to be zero because I’ve done everything in one day, but there are ah, three different turnarounds we are looking at. There is a submission turnaround,

which is our, the date between or the number of days between when the visit was complete to the initial submission of the Trip Report We have an approval turnaround, which is the number of days from initial submission to final approval. And then the total turnaround is site visit complete to Trip Report approval So, if you have some internal goals or guidelines on, you know, the Trip Report must be submitted within two weeks of visit complete and the Trip Report must be approved within four weeks or three weeks of visit complete, then this is the place for you, ah, capture those matrix and actually look at those outliers where we’ve gone over our internal goals for Trip Report approval. And as soon as you identify those, you can always go into that Trip Report and go into the approval history, and very easily see, you know, what caused that delay So, maybe it was submitted and it was sitting in a manager’s inbox for a week before it, it, you know, got any attention. Or maybe it took longer for the monitor to submit it or whatever. There is quite a few iterations between rejection and submission and approval So, you can, based, based on those matrix, you can actually go into the details and find out what actually occurred on that specific Trip Report and you know, narrow down there was a delay. You can, you can really track the progress of your organization’s progress in this area Jump back into our qualcom at look at our questions. Let me see here. One of the questions was: Are there character limit in any of those fields? In the text fields in the follow-up views, the character length is, I think, right now set up as about 500 characters. So a lot of the description and comments fields are quite long. But, you know, for those of you that know Siebel that any field that we want to extend or make larger, we can do that very easily with configuration. But we’ve done our part in ASCEND to make sure the description and comments fields are quite lengthy. And also, in some of those fields we’ve also included spell check on a lot of those description and comments fields as well Question: Is there any way to link this to Oracle’s RDC system and the answer to that is absolutely yes. We’ve actually done that for a number of clients and linked it to a variety of systems Oracle, you know OC and RDC being one of them and December’s 2010 our webinar actually talked specifically to that question. So we addressed, we presented on OC/RDC integrations with Siebel Clinical What was, One of the questions was: What was criteria for the CRFs on the Trip Report? So, in ASCEND out of the box, what we have done, you know, is put in certain flags so the monitor who’s filling out the Trip Report will actually have to select which CRF gets monitored. And, so, select it for inclusion in the Trip Report. So it’s a check/flag that allows us to import those selected items directly into the Trip Report. We do have some clients that have taken and added some additional functionality, so they didn’t want to rely on the check/flag so they came up with some other criteria that was a little more systematic So, you can do that. You know, each client, you know, you would have to come up with some criteria that makes sense, and if its integrated with OC/RDC system, then there’s certainly ways to be able to systematically select the

CRF records that were recently updated. After, anything that was created or updated after the last site visit, for example. So that’s some of the criteria that clients have used in the couch, not only for CRF records, but for protocol deviations records. SAE records anything that has been updated or created since the last time the, since our last site visit report. It can be automatically imported Another question for the submission turnaround matrix: Are you using the initial submission date or the last submission? We are using the initial submission date. So, that is why we had three different statuses. One was submitted, the second one was resubmitted. So after rejection, we actually create the status of resubmitted so it’s clear where the initial submission was and what the latest submission was. So, our turnaround matrix is related directly to the initial submission date Another question here is: Are our Trip Reports submitted to the sites and if so, is there a way of tracking that as a status? I’m not exactly sure what that means. If we submit the Trip Reports to the sites directly? If , you know, certainly, the process is, if there’s, if there’s interim statuses that are related directly to a different kind of submission, if it’s submitted to a site for review before submit to a manager, you can certainly add a submission status, uh status values to that list. You’d just have to define it and potentially, you know, since we’ve created buttons for submissions and approval, if it was a different type of status that we wanted to carry the Trip Report to, we would have to create a button to account for that as well Another questions is: Can you search across Trip Reports on a particular topic? So, I’m going to share my application again, and show where we can search across, um, Trips Reports, so I’m going to go into there’s a site visits view, okay. And you can actually, you know, if you give your user the ability to do this, you can actually search across all site visits that are entered or created within the system And, again, this is where you would go to query on Trip Reports approvals, turnarounds, submission turnarounds. So, anything that was greater than two weeks, for example, would then show up here and you could fine tune your query. But this is where you would go to search across all site visits across the application. So, if there are particular, you know, site visits or date range or just looking at anything, any and all Trip Reports that are currently at the status of rejected, for example, that is something that you can do at this level. So I guess that answers that question. I’m not sure what you meant by Trips Reports of a certain Topic, but this is where you would go to search across any attribute that we have for any site visit in this system So, um, the next question: When a report is submitted and reviewed for a manager, is there an ability to notify the manager via an email? Absolutely. So, we actually set that up for a number of our clients as well. So, when you setup the system, and you setup your site team, for example, you can actually indicate who is your study manager or who is going to be reviewing and approving the Trip Reports And email is attached, or email is one of the attributes or for each of your internal site team. So the monitor and your manager approval and your manager will all have emails attached to them. Or, you know, addresses attached to them. And we can configure the system via work flow, so as soon as you click on that submit button, not only does it walk

you through that, you know, changing that status to submit, but it would also at the tail end of that after he changes that status, could send an email directly to the manager that needs to approve that Trip Report. And the manager would get an email saying that this, you know, that this sites site monitoring Report is now ready for approval or review and approval. And similarly, if they reject that particular site visit or that site visit report, if a manager rejects it, we’ve also sent an email automatically to the submitter of that trip report. So, something they submitted has been rejected so it requires an action on their part as well. We’ve definitely done that via email through the work flow feature In addition to that, And I’m going to share my application again. Now, in addition to, what we’ve done in the system is actually wrap out anything that requires action from a Trip Report perspective directly to the home page. So we have programs, protocols and sites. We also have My Trip Reports. If there is a Trip Report, let me actually reject one. Then, um, we have one that shows up there So any Trip Report that is assigned to me that has a rejected status or a, or a any status that requires some sort of action on their part, so anything that is not approved would show up on their home page So, now that this one is rejected I should see it on my home page in My Trip Reports, so you’ll see that My Trip Reports will show me anything that’s in-progress, not started or submitted or rejected. So each of those statuses will show up here. I want it to prove that it will remove itself from this list So this is just a feature that we have added, again, to route anything that requires action directlyto their home page, so that as soon as they log in, I get to see that there is something waiting for me. But you can certainly do email notifications as well Another question we have is, Can we have a manager approve and then a sponsor approval? So, we’ve dealt with that before as well So, different levels of approval. So, it could be two levels of internal approval or a manger approval and then a sponsor approval. So we have done that as well. Basically, what you have to do is, again, add statuses into the application Trip Reports, so right now, we are just have an approved status. So, we would just have to change that to say manager approval or internal approval then final approval, something like that. And then for each of those statuses if you wanted to utilize that electronic signature capability and re-authentication, you would have to create a button for each level of those approvals. So then we would have the user authenticate themselves at each level of approval. And then each of those would be captured in that audit trail approval history as well Okay, that’s the last question I have on our chat. I just wanted to see if there are any last minute questions before we wrap it up Okay, so thank you all for joining us today I hope, I hope that it was time well spent Like, I mentioned before, we do have additional webinars planned for July, August and September In July, we are going to be discussing the integration between a CTMS Oracle Clinical and an electronic document management system or EDMS. So the webinar is going to include a lot of demonstration, how that type of integration can work. So we’ve created a prototype, and well do a live demonstration of that. I August we’ll be covering Top 10 reasons why you need a CTMS. So this webinar is looking at health

organizations who are working on a CTMS business case put together a compelling argument. And in September, we’ll be looking at Siebel Clinical from a job function perspective. So, for example, if you’re a clinical finance person, how can Siebel Clinical help you do your job. In October, however, we are going to take a break from the webinars because we are going to be attending the OHSUB annual conference in Toronto, and we’re going to be presenting a few sessions there as well and we hope to see you all there Again, thank you everyone for joining us today As a reminder, today’s presentation is going to be available for download from our website within 24 hours. If you do have any additional questions, specifically to this topic, or you would like to discuss your organization’s needs to determine the best options for you around Trip Reports, feel free to contact me directly. My email address is on the screen Again, thank you for joining us and enjoy the rest of your day