DART Form, IRES HIC, and OnCore Shell Training

Transcript

• 00:00Hit record. No.
• 00:06All right?
• 00:10So I think the the the main thing
• 00:13that's new about this initial form.
• 00:15I assume I'm taking this part,
• 00:17is that correct? Is that it's?
• 00:20It's still the same,
• 00:21it's one long dart form,
• 00:23but now the beginning part of this
• 00:25form is a study intake form with
• 00:27just some basic information that
• 00:30would also need to be captured on
• 00:32the dart form about the protocol.
• 00:34The investigator.
• 00:35We know you probably won't have any
• 00:37idea what the HC is at this point.
• 00:39And then what documents that we
• 00:41have and whether or not the API has
• 00:44any interest and the real point,
• 00:46in my opinion of the first
• 00:48part of this forum,
• 00:49in many ways is to document those
• 00:51studies that we're going to decline.
• 00:54And having a sense of what information
• 00:56we had when we declined it.
• 00:59Did we just have a title and we knew
• 01:00right away that we didn't want that?
• 01:02Or did we have the whole protocol we
• 01:04have already had a question about.
• 01:07Can we add something for having we?
• 01:08We have the whole regulatory.
• 01:10Packet and we'll look at that for
• 01:12for future updates to the form,
• 01:14but just know even though that's
• 01:16not on here to complete the rest
• 01:18and the complete dart form,
• 01:20you do need the full regulatory packet.
• 01:23That's the trigger to complete
• 01:24the full dart form,
• 01:25but this first half we're going to complete
• 01:28even if we don't have that full packet,
• 01:31because that we might decide right earlier
• 01:33on that we're going to decline the trial.
• 01:35So this is how we're going to document it.
• 01:37And this is the paper form
• 01:39when this goes into red cap.
• 01:41Hopefully within the next few weeks.
• 01:43The idea is that it will be
• 01:44somewhat of a smart form,
• 01:46and so if you click no no
• 01:48other things populate.
• 01:49If you click yes,
• 01:51then we'll have additional fields
• 01:53to do the rest of the dark form.
• 01:55And we'll be able to generate
• 01:57a PDF once it's in red cap.
• 01:58We'll do more training once
• 02:00that comes out for signature.
• 02:02All right?
• 02:05I think most of the rest of this is similar.
• 02:10We have the data table for
• 02:13clinical research category types.
• 02:15I will say that please always pull
• 02:17up and look at this definition
• 02:18when you are checking this off.
• 02:20Make sure you're asking the investigator.
• 02:22They should really be involved
• 02:24in making this determination,
• 02:25but we do have this wrong once in a while.
• 02:27So just I think your part would
• 02:29be if if when you're doing this
• 02:30something just looks a little bit
• 02:32wonky or doesn't make sense to
• 02:33please escalate and ask the question.
• 02:35Outside of the team and to your managers,
• 02:38if if you need to.
• 02:40Think that the office resources is
• 02:43the same and the funding sources are
• 02:46primarily all the same information
• 02:48that was on the DART form previously.
• 02:51If I am,
• 02:52if I miss something that that
• 02:53was new that I was thinking,
• 02:55was there please just shout out?
• 02:58This is the the part of the form
• 03:00that really the investigator
• 03:02should be helping to complete the
• 03:04the the rationale and the design
• 03:06and the importance for the Yale
• 03:08Cancer Center absolutely should
• 03:09be the investigator competing.
• 03:11Competing protocols is something that
• 03:13you can help to complete and fill out,
• 03:15perhaps at times with the help of the CTM.
• 03:18If you are unclear if certain
• 03:20trials are competing.
• 03:24OK. I think this is straightforward
• 03:28and was part of the form previously
• 03:30about the PRC for others,
• 03:31and about the data safety monitoring plan.
• 03:34A just a note to yourself to make your life
• 03:37easier if you're not already doing this,
• 03:39but if the the protocol doesn't come with
• 03:41the data safety monitoring plan or you
• 03:43don't see something clearly in the protocol,
• 03:45reach back out and get it,
• 03:46because this is often something that can
• 03:49slow things up further down the line.
• 03:52Drug device the same as before.
• 03:55Accrual considerations think the
• 03:57same as before.
• 03:58Oftentimes, we are working with the
• 04:00investigator for the Cancer Center.
• 04:04We just want to make sure that when
• 04:06we're looking at the annual accrual
• 04:08goal and this is something that
• 04:10Christine reminded me of that we
• 04:11kind of look at clinicaltrials.gov
• 04:12about what their goals are and their
• 04:14timeframes are to make sure that
• 04:16the numbers don't look really wonky.
• 04:17Like if we say we're going to, oh,
• 04:19actually, I'm sorry I'm misspeaking,
• 04:21because this is just the goals and I'm
• 04:23thinking about the encore shell which
• 04:25asks the duration and it it's that
• 04:27point where you want to look and say
• 04:29you can't say you're going to do this
• 04:31over three years when clinicaltrials.gov
• 04:32has a primary completion date.
• 04:34A year away from now,
• 04:35since that's something that
• 04:36they will ping you on.
• 04:38Umm?
• 04:40OK, I think that's the same rate as before.
• 04:44As is.
• 04:47This.
• 04:51Same here.
• 04:54Just a note and I think that this
• 04:56is not about the form itself,
• 04:57but I'm going to just stay here to
• 04:59to say that please at the time of
• 05:02this form early on we should be
• 05:03asking this question for the sponsors
• 05:05and basically making the assumption
• 05:07almost that our care centers that are
• 05:08included unless it's a phase one trial.
• 05:11So I think just doing yourselves a favor
• 05:14and and and starting to include that
• 05:16that question earlier with our sponsors.
• 05:23Really quite the same and then the the.
• 05:27Sign off. And that it will be
• 05:29reviewed at the DART meeting.
• 05:34OK.
• 05:38Now we have the prioritization
• 05:39rubric and this is really another
• 05:41part where the investigator,
• 05:43the DART leader in fact,
• 05:45needs to strongly come in.
• 05:47I think the listing the team
• 05:49members has not changed.
• 05:50It's really as we Scroll
• 05:51down and look at the.
• 05:53The scoring rubric so I don't know if you
• 05:56guys have been using this a little bit.
• 05:59This is tweaked slightly so you
• 06:00wouldn't have used this exact one,
• 06:02but does this look familiar with this to you?
• 06:08The only thing that seems to have
• 06:10changed is the point scores.
• 06:12But yes, it's pretty much is the
• 06:14same as of the O dot score sheet.
• 06:15Some things awaited more or less like
• 06:17I know union investigators waited.
• 06:19Well, the definition actually
• 06:20changed used to be 10 years.
• 06:21This is five years now,
• 06:23but it's not nowhere.
• 06:24It's just it's changed a little.
• 06:27But you see, OK?
• 06:28I thought that the I knew I know
• 06:30that the CTMS have all seen this.
• 06:32I was not sure fully about
• 06:34the project managers but just
• 06:36a couple of things to say.
• 06:39Oh, I do have a question.
• 06:40If you could do it now.
• 06:43Yes, so going up.
• 06:47So, Umm, so clinical significance.
• 06:49Both Vera milliliter to tumors.
• 06:52And like I, I wasn't sure where that belongs,
• 06:55because most of our studies are
• 06:57molecular targeted tumors at this point.
• 07:00But they also have,
• 07:01I mean, like self studies.
• 07:02They still tend to score
• 07:04higher than one point,
• 07:05so like which one takes
• 07:07precedence and that they usually
• 07:08score like two to three in the
• 07:10clinical significance scale.
• 07:12In this one, it should
• 07:15be highest priority for.
• 07:17Potential benefit changing practice.
• 07:21Or a rare molecular targets.
• 07:26You know what I'm going to say that
• 07:28that's a good question and I might
• 07:29have to get back to you on that one.
• 07:31But that is one that ultimately might
• 07:34be different depending on the trial,
• 07:36even within cellular,
• 07:37and that the DART leader needs
• 07:39to make that judgment call.
• 07:41And I think that the PRC will make a
• 07:43decision on whether or not they agree,
• 07:45but I think that that's a fair question
• 07:47to say that what if it's one or the other?
• 07:49I would assume that you're going to go
• 07:51with the one that's the higher score
• 07:53if it truly does fit that category.
• 07:55Highest priority potential for
• 07:57patient benefit and practice changing.
• 08:07So for patient availability,
• 08:08I just want to stop on this
• 08:10one very briefly too. We are,
• 08:11and unfortunately I think this is
• 08:13Jessica was asking about this and
• 08:15and she's out today, but she will.
• 08:17She will see this recording.
• 08:20We are working on better ways to
• 08:22get the patient availability from
• 08:24EPIC to actually have numbers,
• 08:26we have analytic cases, or in other words,
• 08:30the number of new cases or first time being
• 08:33treated at our center cases for for diseases,
• 08:36but we really don't have a great consistent
• 08:39way across teams to pull more specific
• 08:42information about patient availability.
• 08:44So in the absence of that we
• 08:46really do need to rely on the DART
• 08:48leaders and and the team to give.
• 08:50Reasonable estimates of what they expect,
• 08:53and I think that you're going to remind
• 08:55yourself because you're looking at
• 08:56this when you're looking at accrual.
• 08:58If you say it's 10 because you
• 09:00want that higher score.
• 09:02And it's really three you're going
• 09:04to shoot yourselves in the foot,
• 09:07because when it's reviewed it a year from
• 09:10now and we haven't met 50% of our enrollment,
• 09:12then it can be put on the list for
• 09:15foreclosure later on down the line.
• 09:17So just be remind your DART leaders a
• 09:19little bit the meaning of this and that.
• 09:21The implications for future review
• 09:23when you're looking at these things.
• 09:27Competing trials prior, we used
• 09:29to actually have this match the
• 09:31the you know, the initial annual
• 09:33accrual question on the dot
• 09:35form has that changed because
• 09:37it's up there above.
• 09:38Yeah, there's a question
• 09:40higher about this as well,
• 09:42but it should be consistent, right?
• 09:44These two should match.
• 09:45Yeah, that's yeah.
• 09:46Exactly what you're saying.
• 09:48As regardless of patient,
• 09:50because we also have we,
• 09:51I mean our doctors have worked to
• 09:53get some numbers for our clinics,
• 09:54but it doesn't really matter.
• 09:55Still with accrual,
• 09:56because all patients won't be eligible
• 09:58depending on lines of treatment.
• 10:00So we still tend
• 10:00to go with the dollar form.
• 10:03Still totally an estimate.
• 10:07Competing trials, I think straightforward
• 10:09care centers investigator initiated.
• 10:14Sponsor type again all straight
• 10:17forward and and the same.
• 10:20Is what has been found here.
• 10:24A little just comment about
• 10:27externally peer funded.
• 10:28I've seen in Encore a quite a
• 10:31few NCTSN trials listed this way
• 10:33incorrectly and just a bit of a
• 10:36reminder that those NCTSN trials
• 10:38that were pulling down from CSU
• 10:41from Alliance and ECOG and whatnot,
• 10:43and I think all of you know this now,
• 10:45and this these are old trials,
• 10:46but I'm just going to point it
• 10:48out because we were QA and this
• 10:50last week those were all national.
• 10:58OK, I think again these ones
• 11:00are all pretty straightforward.
• 11:10And then here comes the the
• 11:13part that is the the really.
• 11:16The new part is that these scores
• 11:18really really mean something now,
• 11:20and they mean something at the DART level.
• 11:22And if something scores a priority
• 11:24zero to five, it does not move
• 11:27forward as it is written to PRC.
• 11:29And I think we all know that the very
• 11:31first question that's going to come
• 11:33back is there are certain trials.
• 11:35That are not going to meet this that
• 11:38we still really, really, really,
• 11:39really, really want to move forward.
• 11:41And I think that that.
• 11:43That question is going to come up
• 11:45probably at the next START leader
• 11:46meeting and at our Seatac meeting,
• 11:48which is our clinical Trials Advisory
• 11:52Committee which is made up of a
• 11:54lot of our Cancer Center leaders.
• 11:55And so I think that this is during
• 11:59this pilot what we're going to be
• 12:02looking at is are there things that
• 12:04are falling into that score that
• 12:06shouldn't and just kind of just know
• 12:08that that those discussions will be had,
• 12:10kind of with the with the
• 12:12leadership and the DART leaders.
• 12:13If you have a trial that falls
• 12:15into that priority level and you
• 12:17know that the DART leader is going
• 12:20to want to move forward anyway,
• 12:22just to escalate it through the
• 12:23ID of the team and the clinical
• 12:24trials manager of the team.
• 12:31OK.
• 12:37It's.
• 12:41So hopefully this will be
• 12:43fairly a fairly painless change,
• 12:46although I know that there will be
• 12:47bumps in the road as soon as we start.
• 12:49Using the form because they're always are.
• 12:56One have any other questions?
• 12:58I I did have one question regarding
• 13:01the funding, so NCI studies.
• 13:02Oftentimes as we know don't like they won't
• 13:06cover the full scope of what the cost.
• 13:10Do we consider them partially
• 13:12funded or fully funded or like?
• 13:13I know some studies do pay more like paradox.
• 13:15I think pays more,
• 13:16but like I know that ecoc,
• 13:18like you know the the national equal
• 13:20studies only tend to have a case
• 13:23statement of like 3 to 4000 sometimes.
• 13:25So do you consider the does it make?
• 13:26So what's the difference going to be?
• 13:28What's the deciding factor between
• 13:29push fully funded and partial funded
• 13:31when it comes to NCI studies?
• 13:33Yeah, let me actually confirm that
• 13:35question with Adam Rashka because
• 13:37I consider them partial funding.
• 13:39Oh, it actually says right here.
• 13:41Partial, but it's also under
• 13:43funding certainly or confirmed
• 13:46art and Cancer Center funding.
• 13:48I yeah, I think we're going to
• 13:50have to look at the funding sheet.
• 13:51Probably of a lot of these.
• 13:54They almost never have full
• 13:55funding if they're in NCTSN trial.
• 13:59Right, OK, so we would mostly
• 14:00consider these to be partially
• 14:02funded then. I'm just not
• 14:04sure what we should do is what they
• 14:07all come with the funding sheet,
• 14:09and so we might have to
• 14:10look at those individually.
• 14:11But this is also a question.
• 14:12Then I'll bring back to I'm Adam Rosback
• 14:16just what determines an NCI
• 14:17study to be fully funded?
• 14:19Because I agree, I also consider
• 14:20those to be partial funded.
• 14:21I just don't know what a fully funded
• 14:23NCI study would be considered like.
• 14:25What does what does mean to cover
• 14:26to meet that definition of fully
• 14:28absolutely? That's a fantastic question.
• 14:32Good question.
• 14:37All right, we're
• 14:38going to stop sharing. Sense.
• 14:43And then we can if no one else
• 14:46has any other questions actually,
• 14:48before we move on, I just wanted
• 14:50to make it clear to everyone that.
• 14:52You know, as we've discussed before,
• 14:54the dark form should be
• 14:56filled out with you and the π,
• 14:59so just want to make sure that you
• 15:01guys don't feel like it's your sole
• 15:04responsibility to fill this form
• 15:06out your role as administrator.
• 15:10Just to clarify Jesse, it's
• 15:12the Dark leader leader, sorry.
• 15:17So yes, I just wanted to
• 15:20clarify that. With everyone.
• 15:27So I was looking at the flow when I
• 15:29when I when I was saying that so that
• 15:31we're going to have to change that.
• 15:33Because the video says API.
• 15:36Yeah, I think the expectation because
• 15:38of the scoring and the ultimate sign
• 15:40off is actually the DART leader,
• 15:41though I would imagine that the API may be
• 15:44depending on the disease group and subset.
• 15:47Have to also provide some information.
• 15:51But ultimately, the final version of
• 15:53the form and what's on there, and the
• 15:55scoring is is at the DART leader level.
• 16:02Can't wait.
• 16:05Who? Christine, do I want to
• 16:09go into HC creation? And of
• 16:11course shell? Yes let me. Share my screen.
• 16:20OK. All right, so first when you're
• 16:25going through and you know starting
• 16:28the HC number and the encore shell,
• 16:31you'll really at minimum need two things.
• 16:34One is the completed signed dart
• 16:37form and the other is the protocol.
• 16:40So this is one that I know
• 16:41RIA has been waiting on.
• 16:42The AC #4. Thank you for allowing
• 16:46me to demonstrate this.
• 16:48It was actually my list to do.
• 16:51I didn't know you were
• 16:52demonstrating it, so thank
• 16:53you. So it was a good timing here, all right.
• 16:57And so then I also have pulled
• 16:59up irez and Encore and the
• 17:04clinicaltrials.gov website, and so.
• 17:07First, you'll want to go into Irez
• 17:10and you'll hit create new study.
• 17:12You can get to this through
• 17:14either it pretty much as long as
• 17:16you're not on the library tab.
• 17:17I believe creative study shows up for you,
• 17:19so if you just don't see it,
• 17:20click on a another tab.
• 17:23And then it'll ask you for
• 17:25some basic study information,
• 17:27and so with with this,
• 17:29the title of the study
• 17:31you will want to match.
• 17:32Kind of our format for Encore as well.
• 17:35And so I'm going to go to the protocol.
• 17:39And copy the title.
• 17:47Back could be a lot of navigating
• 17:50here, so I will start with the
• 17:53protocol number. Oh no was it 1?
• 17:57I have to double check that.
• 17:59And then.
• 18:02In Ankara, we all will also
• 18:04add the IRB record here.
• 18:05I don't know the IRB record
• 18:07for this one at this point.
• 18:10Have to look at other
• 18:12documents that we've received,
• 18:13so I'm just going to kind of remove it now,
• 18:17but this would match the equivalent field
• 18:20and encore and then for the short title.
• 18:23Actually let me make sure
• 18:24the study number get 132 OK.
• 18:28Then for the short title,
• 18:29you're kind of going to do the same
• 18:32thing where you start with the.
• 18:34The number we usually use a comma
• 18:36here just to visually and encore.
• 18:39It looks a little better and then
• 18:42you can enter the clinicaltrials.gov
• 18:45short title if you don't have the
• 18:49clinicaltrials.gov short title,
• 18:50you can use the the study title as well.
• 18:53On for this specific study on the Protocol,
• 18:56I didn't see a clinicaltrials.gov number.
• 19:02But my best guess is that it is
• 19:05this one from Googling the the
• 19:09title that it is this one,
• 19:11but I am going to kind of skip over
• 19:14actually entering this information
• 19:16just because I would confirm with
• 19:19the sponsor 1st instead of having
• 19:21to kind of go back and correct it.
• 19:23So for now can always update it,
• 19:25but for now I'm going to use
• 19:28the the same title here.
• 19:30For brief description,
• 19:31we typically copy the objectives
• 19:34from the protocol.
• 19:35Umm?
• 19:39Hopefully the table of contents
• 19:41allows me to just skip down there.
• 19:45Nope, maybe not.
• 19:47It should be linked, it does OK. Umm?
• 19:52So we at least copy the like primary
• 19:56and secondary if if there's space,
• 19:59we can copy the exploratory,
• 20:02but at least do the primary and secondary.
• 20:08And I can come back to kind of reformat
• 20:11that without wasting everybody's time.
• 20:14So for the IRB, they do,
• 20:17the the application will actually change and
• 20:20the functionality of the system will change.
• 20:22So definitely make sure you
• 20:25answer this question correctly.
• 20:27So this is definitely a
• 20:29multi site industry trial.
• 20:31None of the none of these statements apply,
• 20:33so I'm going to select none of the above.
• 20:37I'm going to most of our studies that
• 20:39are industry have an external IRB.
• 20:41I'm so I'm going to say yes.
• 20:42I don't know if it's weird bar yet.
• 20:45Actually advarra all right?
• 20:47Well, let me just thank Yuria.
• 20:53Just see that.
• 20:56So for now I am listed as the Pi,
• 20:59although it is Doctor Estupi,
• 21:01but for now I'm going to keep my name here.
• 21:04And this will help with like proxying,
• 21:06getting the proxies there.
• 21:08So I don't know of a financial
• 21:11conflict with Doctor Isufi and Abby,
• 21:13who's the sponsor and then does it
• 21:16prospectively assign research to subject
• 21:18to research subjects to one or more
• 21:21interventions, and so this one. Is. Yes.
• 21:29Christina I may have made missed this,
• 21:32but did you have to put yourself as a
• 21:34local principal investigator or does it
• 21:36automatically populate because you're
• 21:38automatically populates just
• 21:40because I opened the opened to
• 21:42create a new study? The default
• 21:46Christina can I ask another
• 21:49question for the financial
• 21:50interest related to this research?
• 21:54If we haven't done any FTF's or
• 21:56anything like that, are we just
• 21:58always assuming the answer is no,
• 22:00and then we go back and update it?
• 22:01Or are we supposed to ask
• 22:03the investigator each time?
• 22:05At this point, you know as you get
• 22:08to know your your PI's and your
• 22:11industry sponsors the big ones.
• 22:13Usually you kind of already know,
• 22:15but just by default answer no.
• 22:17For this one it does connect.
• 22:20Iris does connect to or there's a review
• 22:23for the COI system where the PI's,
• 22:25I believe annually have to enter
• 22:28their conflicts in there and so.
• 22:33I would say no for now and then
• 22:35unless you absolutely know otherwise,
• 22:37and then regulatory will come in here
• 22:39and kind of verify based on their
• 22:42information as well. OK, thank you.
• 22:47All right, so prospectively assigning
• 22:50we have health related outcomes, yes.
• 22:55And then you'll want to go
• 22:56and attach the protocol.
• 22:57Here I'm just going to
• 22:59kind of skip this for now,
• 23:01because the IT takes a little bit to load,
• 23:03but essentially you just
• 23:04attach and find your document.
• 23:10And if you hit continue,
• 23:11it'll essentially then give you
• 23:14the HIC number with with kind
• 23:17of the application shell here.
• 23:19So I'm just going to say
• 23:21all protocol right here,
• 23:22because we do need an answer.
• 23:27And then so once you're here.
• 23:31They just kind of hit save
• 23:33and I would navigate to.
• 23:37The next piece of that you want is
• 23:40the local study team members, so.
• 23:44Kind of skipping most of the
• 23:47application and coming here so I
• 23:50don't have the team members off the
• 23:52top of my head so I am going to.
• 23:54I'm going to put Ria here.
• 23:59And at this point, what your goal
• 24:02is is to add the study team members
• 24:06at minimum that you'll want to.
• 24:09So that's essentially all regulatory.
• 24:12If you have the sub investigator list.
• 24:16It would be helpful to
• 24:17have them listed as well,
• 24:18but at minimum you'll just want
• 24:22the people that need Pi proxy to
• 24:25be added kind of immediately.
• 24:27So if you're not listed here,
• 24:29you won't have access,
• 24:30and so if you need it to
• 24:32eventually come to regulatory,
• 24:33you'll want to make sure
• 24:35to add regulatory here.
• 24:37So just as if as if RIA were a coordinator,
• 24:40and then add her in here and then,
• 24:43you'll want to add the like.
• 24:46The activation coordinators,
• 24:47so I'm going to add my something here.
• 24:56Everything.
• 25:20At this point we do want all of the like
• 25:25regulatory managers kind of listed in here.
• 25:30And proxy need so that we can help
• 25:33cover for our staff as needed.
• 25:35And then I'm going to add in my
• 25:38activation coordinators as well.
• 26:02OK.
• 26:06That's I think I will leave it to this
• 26:08for now, but you guys get the idea.
• 26:11I think you know you can also add in the CTM.
• 26:17Your maintenance coordinator should
• 26:19probably also be listed at this time.
• 26:22All Reg managers the senior Reg managers
• 26:24and I think Amber wants to be listed too,
• 26:27but just for the purpose of the demo.
• 26:29Sorry Christine, it's Dominique.
• 26:31Do we have a list of all of the
• 26:34regulatory coordinators? Because
• 26:35I know for my
• 26:36different DART teams they gave me.
• 26:39Some of the coordinators like
• 26:41Allison like Allison Canola and like
• 26:44Marcy Garcia, but these other ones.
• 26:46I don't think they have on my list.
• 26:50Yes, I can show you there.
• 26:53We have a little chart on the
• 26:56activation tracker on like team
• 26:58contacts and so you can see which
• 27:00red coordinators kind of aligned with
• 27:02your dart and also the manager is
• 27:04listed there and that whole activation
• 27:06is listed on that spreadsheet that
• 27:08like you gave me access to OK.
• 27:14And you know, Bria could be added
• 27:16on here for phase one, but just to
• 27:19save a little bit of time here. Umm?
• 27:26So then you can essentially hit save and
• 27:32exit. Give it a moment to save here.
• 27:42Any day now.
• 27:47I'm just hoping you won't
• 27:48crash on me or anything.
• 27:51There we go all right. OK,
• 27:53so now this is kind of the important step.
• 27:56If you exit out of the application so
• 28:00it's listing me, it's listing no proxies,
• 28:03and so because I'm listed as the API for now,
• 28:07I can essentially assign proxies,
• 28:09so just pretty easy just hit assign
• 28:12proxies here and then you can.
• 28:14Best part is that you can just
• 28:17click everybody on your list,
• 28:19so you'd want to do this.
• 28:22To all regulatory coordinators.
• 28:24Yeah, I don't know if you actually want
• 28:26to be a proxy or not, but well, I can.
• 28:28Maybe for this one.
• 28:32And then you add them here and you hit OK,
• 28:35and then they will all pop here.
• 28:39So unfortunately, unless you're proxy,
• 28:41you cannot submit the study.
• 28:42You can't respond to correspondence.
• 28:46You couldn't do any mods later.
• 28:47Adding other people,
• 28:48and so that's why we just up front,
• 28:51essentially at everyone possible to proxy.
• 28:55And I think it sorry,
• 28:57go ahead, go ahead.
• 28:59Proxy to just create the HIAC.
• 29:03No. So I'm I'm wondering if it
• 29:05would make sense not to add,
• 29:07because they'll essentially roll
• 29:08off the project as soon as it's
• 29:10activated and won't be in Iris anymore.
• 29:12I just don't want them getting
• 29:14a bunch of emails perhaps.
• 29:18And and we can always,
• 29:20you know, remove them too.
• 29:23It's easier to remove proxies than than add.
• 29:28But yeah, the the PM's do
• 29:31not need to proxy themselves.
• 29:33Can it would be easy to just kind
• 29:36of go in here and and say no.
• 29:38And update the list as long as
• 29:40I'm listed as the API there,
• 29:42it's it's easy to to manipulate.
• 29:46And so. At least you know.
• 29:50Make sure to just be adding the
• 29:52regulatory team here and then what
• 29:54you'll want to do before you say,
• 29:56OK, I'm done is.
• 29:58Go back and make sure that
• 30:01you are not the Pi.
• 30:03And so I'm going to come back here.
• 30:06Change the π.
• 30:13And add doctor Sufi here.
• 30:16And it update and hit save.
• 30:27And then once I exit, you'll see
• 30:29that there's I no longer have the
• 30:31ability to change proxies there. Umm?
• 30:40There's still a lot of people
• 30:41in the system right now.
• 30:45OK, well while that's waiting,
• 30:46let me log and talk.
• 30:54Alright, so we got the HC number
• 30:57assigned to this one at least.
• 30:59And so we can start the encore cell.
• 31:03So the easiest way for me is I
• 31:05just never get over to PC console
• 31:08and I start new protocol. And so.
• 31:14OK, all right. Well, we'll continue for now.
• 31:17So in here I'm going to put the.
• 31:23Me zeros is that for five?
• 31:299 of 20 zero. Right?
• 31:37So I'll so the protocol number
• 31:39should be the assigned HAC
• 31:41number that you've just created.
• 31:45Nora's library is oncology
• 31:48your organizational unit.
• 31:51Is Cancer Center?
• 31:52You will want the NCT number I.
• 31:55I'm leaving this blank only
• 31:57because I want to confirm with the
• 31:59sponsor before I add it in there.
• 32:01Department will be.
• 32:07There we go. Oncology the exception.
• 32:10Here, I believe, is for PEDs.
• 32:11They will put PEDs here for the department,
• 32:17but this one specifically oncology
• 32:19so then the easiest thing then
• 32:21to kind of complete the rest
• 32:23because I've already nicely
• 32:24done the title and short title.
• 32:26I'm just going to come here.
• 32:28And copy and paste.
• 32:32What I have done?
• 32:39Objectives are pretty much
• 32:41the same thing of the.
• 32:44Proof description that we're adding
• 32:47in the primary and secondary. Umm?
• 32:58Try to format this at least slightly
• 33:01nicely. Just kind of looks better.
• 33:05But I mean I can. At this moment. Thank you.
• 33:13Thank you.
• 33:16OK. You do that for now.
• 33:18Right, so then you can continue here.
• 33:23So this is where you'll
• 33:25probably get some of these from
• 33:27the dark form as well, but.
• 33:30Umm? Let's see, uh phase.
• 33:35So for phase we typically add
• 33:39the whatever the protocol says.
• 33:42Sometimes you can refer to
• 33:44what clinicaltrials.gov says.
• 33:49Let me look at the protocol here.
• 33:51Let's see what it says.
• 33:59Case 1B2.
• 34:15I'm going to select one to two.
• 34:17I don't think we normally or 1B2.
• 34:25And B2 is an option. OK, all right?
• 34:28So we'll go with 1B2.
• 34:30This one it's not local or international.
• 34:34I took a peek at the protocol.
• 34:36It didn't seem like it was international,
• 34:37so it would be local or sorry national.
• 34:41This one's in adults.
• 34:43There is a ID and drug accountability needed.
• 34:48It is not investigator initiated.
• 34:52Umm for? Involves therapy.
• 34:59You you would select NA if.
• 35:03No therapy is being given
• 35:05as part of the study.
• 35:07So this one should be yeah.
• 35:12All right, it is not only open for affiliate.
• 35:17On the summary, it's not only.
• 35:22A cruel summary, not a cruel summary only.
• 35:27OK, then protocol type.
• 35:29This one is a treatment study.
• 35:32This should also be on the
• 35:35dark form I believe. Umm?
• 35:38Cancer control does not look like this
• 35:44study this, I would say this is more true
• 35:46cancer treatment versus cancer control,
• 35:48so I'm going to say no and it's
• 35:51not really cancer prevention.
• 35:54So this should also be on the dart form.
• 35:56This one is interventional.
• 35:59Registration Center this is.
• 36:02An external registration center sponsor site.
• 36:05Involves correlates or companions for.
• 36:09For this,
• 36:10I believe we want to only select yes.
• 36:15If we're using.
• 36:18Is this one?
• 36:19It's another protocol hold on.
• 36:22No, I'm getting confused on
• 36:23which one you switched here Sir.
• 36:25Is this one of the ones that
• 36:27you had to clarify or was this?
• 36:28No
• 36:29change did not change this one.
• 36:32OK then, then we always select no OK.
• 36:36It's like no less identified during
• 36:39activation startup so much still for
• 36:40sure that it's yes I would select no.
• 36:43OK, all right
• 36:45so so I just have a question on that.
• 36:47So for example,
• 36:47a lot of our studies have like long term
• 36:50follow-up studies that accompany them.
• 36:51Is that considered a companion study then
• 36:53or no like it sounded like it's only yes,
• 36:56it's a different protocol.
• 36:58Is that correct?
• 36:59Like so long term follow-up so
• 37:00they would be a separate hi.
• 37:02C probably usually is so that
• 37:04in that case it would be a yes.
• 37:09I would put that as a yes first.
• 37:10So for instance, for like the
• 37:12cellular therapy where they have
• 37:14the separate protocol follow-up,
• 37:15I think that it would make
• 37:16sense for them to be linked.
• 37:18That would be the companion study.
• 37:21OK, so companion only is yes if
• 37:22there's going to be separate HC that
• 37:24would be linked to this one, correct?
• 37:26So I can think of another one was
• 37:28way back when the lung map when it
• 37:30had a separate screening protocol
• 37:32number and then all of the sub
• 37:33arms were separate and so they
• 37:35might be linked as a companion.
• 37:38OK, thank you perfect.
• 37:41Data monitoring they have an external.
• 37:45Don't think this has adjuvant treatment.
• 37:48I can go back and confirm with the protocol,
• 37:50but I don't think I saw that.
• 37:53Includes special making.
• 37:54This will be no unless you're
• 37:56using the biospecimen module,
• 37:57which I don't think we do.
• 38:00We never do, so it's always no,
• 38:02always no. Welcome.
• 38:05No companion study that I'm
• 38:07aware of for this one yet.
• 38:10And then for multi site trial we are
• 38:13we want to select yes if you are
• 38:17recruiting from multiple sites and so
• 38:20this would now be the same as when
• 38:23you're answering it in the IRB system
• 38:27in IRB before they used to be different.
• 38:29So you might see some trials right
• 38:31now that that have no just because I
• 38:34think we used to answer this pretty
• 38:36much from an IT only perspective.
• 38:38And so as I understand it.
• 38:40We do want to see.
• 38:42From a like let's say a data
• 38:44table 4 perspective,
• 38:45but just a general perspective,
• 38:46if it's multi site.
• 38:48This does have an investigational drug.
• 38:52It is not precision.
• 38:54If it were precision,
• 38:56you could enter the classification.
• 38:59It is not a pilot, there is no
• 39:03device and I believe the dark
• 39:05form did not have this as rare.
• 39:13OK.
• 39:17All right, that was our main tab.
• 39:21Now we're going to enter
• 39:23the accrual information.
• 39:23Pretty much how it appears on the
• 39:26dark form here on the screen.
• 39:31Is this too small for you?
• 39:32Guys are getting some kind of see?
• 39:36OK, so the protocol tiger
• 39:39decool come from the protocol.
• 39:41If I can't find it very quickly,
• 39:43I can come back and and add it in.
• 39:56Just go to the summary, really
• 39:57quick, see if it's. In there.
• 40:08Honestly, for this protocol is going to
• 40:10be variable because it's the phase one.
• 40:11So like they were estimating
• 40:14approximately 100. Yeah, yeah.
• 40:15Like yeah, exactly OK. Yeah,
• 40:18put 132 for now, just because that's
• 40:20what they're kind of guessing.
• 40:25OK, so lower accrual is 8 based on
• 40:29the dart form. Upper cruel is 15.
• 40:36Annual accrual
• 40:40leave. Affiliate accrual blank and then
• 40:43the accrual duration in months. You can.
• 40:47Essentially get from. Ctsu as well.
• 40:54Don't don't think it's
• 40:54actually put on the door form.
• 41:01Let's see. Umm? Let me just see if this. Has
• 41:13we should date 2024?
• 41:20OK, so we can confirm this, but.
• 41:23I'm guessing that the it'll be at least
• 41:2624 once I get the actual NCT number.
• 41:29I can kind of confirm that,
• 41:32but I don't want to.
• 41:35In the same thing here,
• 41:36so the completion estimated
• 41:38completion was. Umm? 2024 November.
• 41:54Oh sorry, primary completion date.
• 41:57Actually, let's put it there.
• 42:05I think that would actually
• 42:06be the same as the.
• 42:10Let's say completion date.
• 42:11Let me just look really quick on.
• 42:18Yeah, grab it from clinicaltrials.gov, OK?
• 42:22Alright, so I'm just going to remember
• 42:24to kind of come back and double
• 42:26check these when we get the actual.
• 42:28Clinical trial that group number. All right?
• 42:34I'm going to hit submit.
• 42:42A minute to think you do want these
• 42:44numbers to kind of make sense,
• 42:47so if you're going to accrue 5
• 42:50a year and your upper is 15,
• 42:53you would hope this to be like three years.
• 42:57I guess if you're thinking that
• 43:00the upper 15. Umm? You know?
• 43:06Maybe I'll get back to you.
• 43:15Real the upper is 15 at 5:00,
• 43:17so you aren't expecting to
• 43:19accrue for three years, huh?
• 43:22That's what we were expecting,
• 43:23yeah? OK, alright
• 43:27so then just for.
• 43:37It just to make sure that
• 43:38it kind of all matches.
• 43:39I'm going to put that you have. That's.
• 43:47All right, OK, so that's kind of the
• 43:50me that's the main page of encore.
• 43:53And so now it kind of looks like
• 43:57this and so. You're not done.
• 43:59I kind of gotta go through these tabs
• 44:02and then we'll go down the side here so.
• 44:04For management, is there OK?
• 44:08For management group. UM?
• 44:14The IRB number would go here.
• 44:25For now, you're going to say
• 44:27no to PRC review required.
• 44:29The regulatory coordinator will
• 44:30come in and say yes when they're.
• 44:33Ready to submit to PRC.
• 44:36This is always no.
• 44:41Umm?
• 44:46You can add the NCI trial ID if
• 44:49you have it as it's assigned.
• 44:52Actually this will be the.
• 44:55Who would give this to you?
• 44:58Once it's registered, right?
• 45:01CTRP so you probably don't
• 45:03have that at this point.
• 45:07And then for the.
• 45:12Program area and administrative groups.
• 45:16This we go based off of the
• 45:19investigators like profile page or
• 45:22like their program area assigned,
• 45:24and so I've I've honestly found the
• 45:27fastest way to do this is just to.
• 45:30Google Investigator and find their Yelp page.
• 45:38It should be this profile.
• 45:41And so then I'll kind of come down here,
• 45:44and it looks like her organization
• 45:47has developmental therapeutics,
• 45:49so that's usually what we list.
• 45:53We go. At that.
• 45:59You'll want to select
• 46:01primary on all of these.
• 46:06Disease unit for this one is leukemia.
• 46:11No. Lymphoma, lymphoma.
• 46:13All right thank you.
• 46:15Trying to remember from the
• 46:17and you put it in the email.
• 46:18Anyways alright then
• 46:20how did doctor Susie? Anyway,
• 46:21since she's in a few doctors.
• 46:24And then look for my here.
• 46:30So you'll always want at least one primary.
• 46:32I know sometimes there's multiple,
• 46:34but just make sure that you're
• 46:37selecting primary on those and
• 46:39hit submit so it all saves.
• 46:40Alright, that's the management tab.
• 46:42Then on the staff tab.
• 46:46I think we decided at least try to add the
• 46:50sub investigators if you have them here.
• 46:57I have found that the easiest
• 46:59thing is to kind of select the team
• 47:02from another protocol and then
• 47:03you know you can kind of edit it.
• 47:05I think just I can show you guys how.
• 47:08So essentially going to select the team and
• 47:11here you can type in the another HIC number.
• 47:14And then it'll just pull over that staff.
• 47:18Umm? And then if you need to add
• 47:22people individually, you know you'd
• 47:23be adding like regulatory coordinator.
• 47:25I'm just going to put stuff in me here.
• 47:30Go to hell.
• 47:43So you'll also want to at least
• 47:46at the beginning at the Pi. So.
• 47:53Back here.
• 47:58Add and that'll populate the name of top
• 48:02here so you can then continue and add.
• 48:05You can add you know your
• 48:08regulatory coordinators,
• 48:09sub investigators, your CTM.
• 48:13Or you can pull over team
• 48:14from a recent protocol.
• 48:15If you've just done this from another one.
• 48:18So I'm gonna skip over
• 48:21adding a million people here.
• 48:23Then for the sponsor you
• 48:25don't want to update this,
• 48:26you're going to add sponsor and you're
• 48:29going to want to select the name here.
• 48:31App is listed.
• 48:32And add if you do not see
• 48:35the sponsor listed here,
• 48:37you would email the on court
• 48:40on course support group email.
• 48:42They usually ask for general like
• 48:45the address contact info and
• 48:48the sponsor name and the type.
• 48:50So if it's like industry or. Umm?
• 48:54In like an another institution or.
• 49:01Like a foundation for example.
• 49:04So here I put in the
• 49:06sponsor protocol #2 to 132.
• 49:12And you want to put that
• 49:13there the principal sponsor.
• 49:14This will put them up there.
• 49:18And add their roles.
• 49:19They are the agent source,
• 49:21their duty and get analysis.
• 49:23They're doing design and they're funding.
• 49:29Oh, I didn't save. I forgot.
• 49:32Yeah, so when you're going through this?
• 49:36There are certain pieces that
• 49:37if you don't submit on court,
• 49:39we'll forget to save.
• 49:42UM, if you're doing like an IIT,
• 49:45your primary sponsor would be like.
• 49:49Yale Cancer Center and then do add.
• 49:53You know like if if Merck providing
• 49:55drug do add Merc and then label
• 49:58them as like an agent source.
• 49:59Or maybe they're just providing a little
• 50:01bit of funding for them as funding source.
• 50:03You can also put like NCI as
• 50:05a funding source so the more
• 50:06information and more details you
• 50:08can add here the better in general.
• 50:13Then for the IDE taxi Ind tab,
• 50:16yes there is an Ind.
• 50:19I'm going to look in the protocol quick.
• 50:21I don't remember seeing the
• 50:22ending number here, but.
• 50:28No, I don't see any number,
• 50:30so this is something that I have
• 50:31to ask the sponsor before adding,
• 50:33but let's just say I have it.
• 50:35I would add that I ID
• 50:37number here the ID number.
• 50:39This would be it.
• 50:41A holder type would for this one
• 50:43specifically would be industry.
• 50:46The holder name here would be happy.
• 50:49Actually I just put this here so
• 50:52remember to come and then the granter.
• 50:55For this one you can choose
• 50:57either cyber or seeder.
• 50:58I'm positive based on
• 51:00the number you can tell.
• 51:02I'm pretty sure this one
• 51:04is going to be cedar.
• 51:06So once I get the number.
• 51:09The Seeder icnd numbers have an
• 51:12extra digit, essentially. Umm?
• 51:14So if there's a depends on how many
• 51:18digits there are, I think there's.
• 51:21Five or six for Cedar. Umm?
• 51:25All right? So have that. Umm?
• 51:34For. For the clinicaltrials.gov tab.
• 51:40I'm just now seeing.
• 51:43Don't think we necessarily complete.
• 51:48Complete anything here. You
• 51:54yeah, OK, if it's an IT, I think
• 51:57the ID office might. Thanks.
• 52:02OK, all right. Umm? Then for
• 52:07the treatment tab you can add.
• 52:10On this page the. The disease area. Uh.
• 52:21I usually browse through the
• 52:23protocol to see if there's other,
• 52:25but I know that was at least in the title,
• 52:26so I'm just going to add that for now.
• 52:30And some of that page.
• 52:32Under institution you'll
• 52:34want to make sure that Yale,
• 52:37at minimum, is listed.
• 52:42Carl is so safe.
• 52:46This puts Yale University at
• 52:48like a institution level,
• 52:50but to actually add Yale as a a study site,
• 52:53you'll have to go into hit the hyperlink.
• 52:57Go to study sites here. Umm?
• 53:01Update and check box Yale.
• 53:04I know that's not necessarily a
• 53:06fun path to kind of go around.
• 53:09But if you forget,
• 53:10just just let me know,
• 53:12I'm happy to walk through it.
• 53:13Sometimes you just have to remember
• 53:15to go to hit the hyperlink and
• 53:17then from there you can kind
• 53:19of remember and go back.
• 53:23Then if you go back to the PC console,
• 53:24it takes you back here.
• 53:25So now Yale University is added as a site.
• 53:28From this point you probably won't
• 53:29have any of the care centers,
• 53:31so you don't have to add those at this time.
• 53:35There's not much in a cruel.
• 53:37I'm just going to go down the tab.
• 53:38Not much in a cruel.
• 53:39Status, this is where you would
• 53:43release the tasks task lists. Umm?
• 53:46Just to show how those are released.
• 53:51Is a task list guidance,
• 53:53but just to show how it's released you
• 53:55would hit whatever cost list you want.
• 53:59Move the task list template to complete.
• 54:04Then move the task list template to release.
• 54:07And you'll see it down below.
• 54:11So you'll see it down here,
• 54:13so this top sections templates only,
• 54:15but that's how you release the template
• 54:16and then this would be ready to use.
• 54:21Nothing for you guys.
• 54:23Now in their reviews tab.
• 54:25Under documents you probably at least
• 54:28want to put the protocol in here.
• 54:32Just going to see how quick
• 54:34the shared drive is, but.
• 54:40OK, that may. I guess I can add the protocol.
• 54:48Let's see how fast it it continue, while
• 54:51depending on how quick the shared drive is.
• 55:03Here.
• 55:06I'm going to leave that as protocol.
• 55:10And the pension date is January.
• 55:16And then you can add.
• 55:22So this is protocol if you want
• 55:23to add more documents, you can,
• 55:25but I think at least the protocol would be.
• 55:29OK, so then I'll really notations.
• 55:32So the next thing that you want
• 55:34to make sure to remember to do
• 55:36is go to the annotations tab.
• 55:39If you're building the protocol,
• 55:40there won't be a form here yet,
• 55:42so you can create one.
• 55:44If that doesn't pop up for you,
• 55:46it's your own core access that can
• 55:48be changed and then #17 that you're
• 55:51the CTO managed study hit yes.
• 55:54Had saved down at the bottom and now
• 55:57it is there, so this has been saved.
• 56:01Umm? All right.
• 56:03So then, the last thing I'm not
• 56:06going to then that I want to just
• 56:09show you is that if you. Umm?
• 56:13If you hit the coverage analysis console.
• 56:16And you go to attachments.
• 56:20They will see,
• 56:21so this the finance team will see the
• 56:23documents that you've uploaded here
• 56:25and in order for them to start any.
• 56:28Financial items,
• 56:29they'll need the draft.
• 56:30The sponsored draft consent form
• 56:32uploaded here so they won't be
• 56:34able to start anything until
• 56:36until they have that listed here.
• 56:38I guess actually if I go back to the
• 56:40PC console and hit the documents tab,
• 56:42this is also where the those.
• 56:47Contract regulatory questions that
• 56:49finance uses would be uploaded here.
• 56:54And I think that's it.
• 56:55So we've gone through all of the tabs.
• 56:58I know that is a lot.
• 57:01Any questions I can answer right now?
• 57:05Or or pieces you want me
• 57:06to go navigate back to?
• 57:14No, no questions.
• 57:18The main question is actually
• 57:19regarding the and number.
• 57:20So if we have the,
• 57:22so how do we know which one it is?
• 57:24It's going to be you said
• 57:26like which you said it's a
• 57:27based on number of digits,
• 57:28which ones, which is my question
• 57:30I see. Yeah, so it's it's you
• 57:33can definitely ask the sponsor
• 57:34to just get their confirmation,
• 57:37but I the seeder ID numbers have.
• 57:41I want to say there's 6 digits and then
• 57:43if you see something that's 5 digits,
• 57:45it's most likely Seeber.
• 57:50And just because there's more cedar?
• 57:52Yeah, I just know that there's an
• 57:54extra digit there. I think it's
• 57:56six I have to go back and look.
• 58:00Right, yeah, so 6 digit number.
• 58:17All right, OK? Any other questions?
• 58:24Can go back here and fix that.
• 58:30You know you have a Sophie as the Pi here.
• 58:32Now that the saved. Here. So.
• 58:38All right, I will stop screen sharing.
• 58:44Thank you so much Christina.
• 58:46Yeah, I I know it's a lot so that was really
• 58:49helpful though, so thank
• 58:50you for going through it.
• 58:53We're gonna stop.