WEBVTT 1 00:00:00.410 --> 00:00:01.460 Kathie Ferbas: Okay. 2 00:00:01.830 --> 00:00:19.769 Kathie Ferbas: Thank you, everybody, for joining. We are going to be doing a live demonstration for you, and hopefully answer all of your questions. We have… the other thing that I want to just tell everybody is we are very fortunate that we have, 3 00:00:19.960 --> 00:00:25.269 Kathie Ferbas: Somebody who has joined us from the Lab Center, Vanessa Pinheiro, who 4 00:00:25.490 --> 00:00:28.410 Kathie Ferbas: Speaks Portuguese natively. He's from Brazil. 5 00:00:28.510 --> 00:00:41.640 Kathie Ferbas: And if we have questions that you all are struggling to either understand something we're saying or to ask your question, Vanessa has very graciously agreed to pop in and do some translation. 6 00:00:41.800 --> 00:00:49.079 Kathie Ferbas: So, please take advantage of that. We certainly don't want anything here today to be lost in translation. 7 00:00:49.850 --> 00:00:51.710 Kathie Ferbas: And thank you, Vanessa. 8 00:00:51.950 --> 00:01:01.230 Kathie Ferbas: So just by way of introductions, my name is Kathy Furbus, and I am the Executive Director for the Laboratory Center. 9 00:01:01.270 --> 00:01:09.390 Kathie Ferbas: We have, with us today Grace Aldervandi, who is the PI for the Lab Center, Will Murtaugh, who is the, 10 00:01:09.390 --> 00:01:22.559 Kathie Ferbas: TB specialist for the lab center, or TB expert, and our technical lead on all things related to my lab, and Sarah Zabi, who is the Lab Center's QAQC officer. 11 00:01:22.560 --> 00:01:28.099 Kathie Ferbas: They're each going to be doing some demonstrations for you to familiarize you with. 12 00:01:28.130 --> 00:01:30.069 Kathie Ferbas: How to, 13 00:01:31.030 --> 00:01:45.650 Kathie Ferbas: operate within our system for how we track documentations for lab activations. So what we will be doing today… oh, I'm sorry, we also have, sorry, Helty. Helty and Diane, who you all will be very familiar with from the, 14 00:01:45.740 --> 00:01:56.209 Kathie Ferbas: from IMPACT, who are here as well today. Any of us, we all sit on the laboratory leadership, and any of us can answer any of your questions at any time. 15 00:01:56.260 --> 00:02:12.289 Kathie Ferbas: And we are happy to help and answer questions. We do things slightly differently than the way that you are familiar with, and so we want to give you insight into how we do things and offer some training. This training will be recorded. 16 00:02:12.310 --> 00:02:31.810 Kathie Ferbas: It will be posted on our website and will be available if people have questions for you to look at at later dates. We also have little bite-sized videos on our website that you can look at for all of the processes for lab activations at any time. So with that introduction, Grace. 17 00:02:31.810 --> 00:02:49.129 Grace Aldrovandi: One more thing I would just add, everything on our website in this, you can watch the video recording, but you can also download a verbatim translation of everything that's said. So if there's a word you don't understand, you may be able to see it in… 18 00:02:49.130 --> 00:03:02.710 Grace Aldrovandi: you know, recognize it if you read it in English, or you could always take that English documentation and put it through Google and translate it into Portuguese. So we really try to make things, 19 00:03:02.950 --> 00:03:05.409 Grace Aldrovandi: As easy as possible for you. 20 00:03:09.210 --> 00:03:12.419 Kathie Ferbas: Thank you, Grace. Okay, Will, you're up. 21 00:03:14.850 --> 00:03:31.540 William Murtaugh: All right, good afternoon, everyone. So what I'm gonna do, today is basically a live demonstration, walking you through, the resources that we have, and then through, the MyLab Central web portal, where, you'll be 22 00:03:31.580 --> 00:03:42.350 William Murtaugh: accessing and, you know, completing PALs, submitting validations, and things like that. So there's a lot of, of, components that, 23 00:03:42.430 --> 00:03:44.520 William Murtaugh: You know, require you to… 24 00:03:45.230 --> 00:04:03.860 William Murtaugh: select various buttons, so I may not go through everything in detail, but as Grace and Kathy said, on our website, there are the training videos that can walk you through in detail, how to complete the various tasks. So this is meant to be, a general overview and 25 00:04:03.890 --> 00:04:17.719 William Murtaugh: We'll be willing to work with you all through the lab activation process, as you get more and more familiar with how to use our process. So, I know this might sound like a lot of information up front, but, 26 00:04:18.399 --> 00:04:21.690 William Murtaugh: There's a lot of resources to help you work through it. 27 00:04:22.000 --> 00:04:31.589 William Murtaugh: So, with that, I'm going to share my screen, and just… Bring up our… Website. 28 00:04:36.180 --> 00:04:42.889 Grace Aldrovandi: And maybe somebody can put the website, URL in the chat for people, even though they can see it here. 29 00:04:43.400 --> 00:04:44.610 Kathie Ferbas: I'll put it in… 30 00:04:46.950 --> 00:05:04.140 William Murtaugh: So, this is the landing page for the ACT Gene Impact Laboratory Center website. So, yeah, it's in all of our email signature addresses, so you can easily access it there. Kathy will put it in the chat for you. 31 00:05:04.430 --> 00:05:07.829 William Murtaugh: But this is a great… 32 00:05:07.930 --> 00:05:13.960 William Murtaugh: Website to bookmark, in your web browser so that you can access it, as easily. 33 00:05:15.890 --> 00:05:23.270 William Murtaugh: And efficiently. So there, from here, you can actually log on to the MyLab, up here in the corner. 34 00:05:23.840 --> 00:05:30.510 William Murtaugh: which I'll show you in a moment, but what I wanted to show you was the resources that Grace had mentioned. 35 00:05:30.630 --> 00:05:36.689 William Murtaugh: that include, the training videos. So, under the tab of resources, if you select the training videos. 36 00:05:37.220 --> 00:05:38.430 William Murtaugh: You can see it. 37 00:05:39.270 --> 00:05:42.360 William Murtaugh: It covers all of the topics that you, you might need. 38 00:05:42.860 --> 00:05:46.009 William Murtaugh: Assistance with, in terms of your processes. 39 00:05:46.230 --> 00:05:52.769 William Murtaugh: From, you know, BRI shipping, All the way through… 40 00:05:53.560 --> 00:05:57.389 William Murtaugh: you know, PBMC processing, and then individual 41 00:05:59.220 --> 00:06:08.679 William Murtaugh: videos for any of the processes, just an overview. These are good, you know, if you need refreshers after this… this training, you can go through 42 00:06:09.250 --> 00:06:10.819 William Murtaugh: and identify 43 00:06:10.960 --> 00:06:20.010 William Murtaugh: you know, any process that you might need to complete within MyLab. We'll have a short little video. Most of them are no longer than, you know, 6 or 7 minutes. 44 00:06:21.310 --> 00:06:26.620 William Murtaugh: But this is just a good resource for you to be aware of, bookmark, and you can… 45 00:06:26.770 --> 00:06:28.759 William Murtaugh: Peruse it at your own leisure. 46 00:06:31.350 --> 00:06:37.410 William Murtaugh: So to access My Lab, you can, from this webpage, if you click My Lab Logon. 47 00:06:39.080 --> 00:06:49.370 William Murtaugh: it'll take you to a sign-in page. So, in order to, get sign-in access, what we'll ask you to do, and Kathy will put the email address in the 48 00:06:49.530 --> 00:06:54.190 William Murtaugh: chat. Let us know if you don't have an account already. 49 00:06:54.230 --> 00:07:13.170 William Murtaugh: We'll ask you to email us a name and an email address, for those that need an account to MyLab. So we have two levels of access, depending on what you're going to be doing within MyLab. So, if you're from the site, and you are trying to monitor 50 00:07:13.870 --> 00:07:17.270 William Murtaugh: the progress of the PAL, 51 00:07:18.510 --> 00:07:21.669 William Murtaugh: Generally, you only need read-only access. 52 00:07:21.770 --> 00:07:34.579 William Murtaugh: we can set you up with a site user account that will give you the ability to log in, look at the PALs, see their progress, but not necessarily be responsible for 53 00:07:34.610 --> 00:07:52.780 William Murtaugh: any of the lab information, you know, instruments, methods, etc. If you are from the lab side, and you will be filling out the PAL with instrument details, method details, you'll be submitting validations, we'll want to set you up with a lab user account. 54 00:07:52.780 --> 00:07:57.199 William Murtaugh: So, when you send us an email, identify what your role 55 00:07:57.280 --> 00:08:06.370 William Murtaugh: Within the site or laboratory are, and we can, Assign you the… the correct a user account. 56 00:08:08.200 --> 00:08:18.299 William Murtaugh: So, for this demonstration, the FIO Cruz and IPIC site have graciously allowed us to use them as an example. So I'm going to… 57 00:08:19.580 --> 00:08:21.000 William Murtaugh: Sign in here. 58 00:08:23.870 --> 00:08:26.999 William Murtaugh: As if I were from the Fia Cruz Laboratory. 59 00:08:32.750 --> 00:08:34.120 William Murtaugh: So, signing in. 60 00:08:34.429 --> 00:08:38.609 William Murtaugh: This will be the landing page of the lab user account. 61 00:08:39.559 --> 00:08:54.260 William Murtaugh: which you'll see a list of any of the PALs that your laboratory is contributing to for all of the sites. So the list of PALs that are currently in progress will be right here at the top. 62 00:08:54.950 --> 00:09:09.510 William Murtaugh: And then if you need to access any PALs that have been finalized, for example, if you needed, you know, to pull them for reference during an audit, anything that's been declawed or lab-approved will be at the bottom. And by selecting load. 63 00:09:10.350 --> 00:09:15.510 William Murtaugh: You can… view any of the… any of the PELs that way, as well. 64 00:09:18.970 --> 00:09:20.040 William Murtaugh: Alright. 65 00:09:20.870 --> 00:09:28.049 William Murtaugh: So before we get to the PALs, the way that my lab is set up is that 66 00:09:28.260 --> 00:09:40.969 William Murtaugh: we require you to have an inventory of instruments and methods entered within my lab. So those instruments and methods are then tied to the PAL. So in order to 67 00:09:41.170 --> 00:09:55.489 William Murtaugh: get all of your instrument and method details into MyLab, what we'll request is that you do validation submissions. So here at the top, you'll see a series of tabs. So for 68 00:09:55.770 --> 00:10:00.339 William Murtaugh: validation submission. If you select Submit Validation. 69 00:10:00.440 --> 00:10:12.130 William Murtaugh: This will give you a list of all the validations that, you know, your lab has on file within my lab, and allow you to submit new validations. 70 00:10:12.830 --> 00:10:16.459 William Murtaugh: So… In this way, 71 00:10:17.020 --> 00:10:25.050 William Murtaugh: if it's a manual method, for example, you know, rapid HIV testing, you know, urine dipstick, etc, 72 00:10:25.690 --> 00:10:26.639 William Murtaugh: you can… 73 00:10:26.910 --> 00:10:34.669 William Murtaugh: move forward with your method submission via a manual method. If there's an instrument tied to it, it'll allow you to 74 00:10:35.900 --> 00:10:42.420 William Murtaugh: add the details of the new, instrument. And as you move forward, it will… 75 00:10:42.940 --> 00:10:52.419 William Murtaugh: progress you through entering additional information about the analytes and the method details. So to show you what that would look like, I'll… 76 00:10:52.850 --> 00:10:54.489 William Murtaugh: Do one example. 77 00:10:58.260 --> 00:11:03.990 William Murtaugh: Here, so on this page, Right, for example, their architect with the serial number. 78 00:11:08.390 --> 00:11:14.940 William Murtaugh: they've selected All of the analytes that would be, tested on that given instrument here. 79 00:11:16.630 --> 00:11:19.810 William Murtaugh: By using this tab, you can… 80 00:11:20.000 --> 00:11:25.369 William Murtaugh: filter for the analytes that you'll be using. You can, you know. 81 00:11:25.790 --> 00:11:33.300 William Murtaugh: Type in and search for, analytes in the search bar, and select them here. 82 00:11:34.610 --> 00:11:36.160 William Murtaugh: So, at the bottom. 83 00:11:36.610 --> 00:11:46.589 William Murtaugh: you'll indicate, is this an initial validation? Is this the first time that you've validated that instrument? Or identify if you've 84 00:11:46.980 --> 00:12:03.689 William Murtaugh: had to do a revalidation, possibly due to, an, you know, an instrument failure that you've, you know, you've fixed the instrument, or you've moved the instrument, anything that would require you to… to revalidate that instrument or method. 85 00:12:04.260 --> 00:12:07.010 William Murtaugh: You would identify it, here. 86 00:12:08.790 --> 00:12:22.159 William Murtaugh: Also, if it's a primary or a backup instrument. The reason that we ask for you to, you know, to tell us if it's primary or backup, is that the requirements for documentation are different. 87 00:12:22.160 --> 00:12:29.570 William Murtaugh: So, for example, if you're submitting a valid instrument for a primary method. 88 00:12:30.620 --> 00:12:36.170 William Murtaugh: The documentation requirements, what we're going to require, here on the next tab. 89 00:12:37.180 --> 00:12:42.130 William Murtaugh: Are all of the validation documents, you know, your validation summary, 90 00:12:42.630 --> 00:12:46.150 William Murtaugh: Any package inserts associated with those test methods. 91 00:12:49.900 --> 00:13:05.080 William Murtaugh: And here you see, as example, they've submitted one, you know, one validation for each analyte, the package insert for that analyte, etc. So any of the associated documents that would need review by the lab center. 92 00:13:06.030 --> 00:13:08.829 William Murtaugh: Would be included, and uploaded here. 93 00:13:10.680 --> 00:13:21.650 William Murtaugh: And then if there's any notes, for context that you would need to make us aware of, for example, the study, that you intend to use this, these tests for. 94 00:13:21.750 --> 00:13:24.330 William Murtaugh: They performed, and then, 95 00:13:25.610 --> 00:13:27.540 William Murtaugh: You can either save and exit. 96 00:13:27.770 --> 00:13:40.219 William Murtaugh: as you're gathering information, submit it at a later time, or once you've completed all of the information, you can submit it to the lab center. So upon submission to the lab center, we'll review it for, you know. 97 00:13:40.220 --> 00:13:49.940 William Murtaugh: completeness, ensuring that everything that we received from you makes sense. You didn't, you know, accidentally upload information, that wasn't relevant, or… 98 00:13:50.890 --> 00:13:59.730 William Murtaugh: you know, there's no typos or any of that. Once that's been completed, we will forward, this on to Peacemile, who, 99 00:13:59.960 --> 00:14:09.059 William Murtaugh: helps us with the technical review of the validations. And from there, they may have some conversations with you about 100 00:14:09.270 --> 00:14:18.379 William Murtaugh: you know, the completion of the validation, any additional information that might be needed. And once that process is completed, 101 00:14:18.610 --> 00:14:24.729 William Murtaugh: They'll upload their form, provide their, review approval, and 102 00:14:25.360 --> 00:14:36.589 William Murtaugh: From there, the lab center will then approve it, and that instrument method will be committed to your inventory. So all of that is… this is happening on the front end, so that… 103 00:14:36.760 --> 00:14:45.259 William Murtaugh: the process of your PAL completion, can be, you know, as easy as possible. We basically confirmed up front 104 00:14:45.410 --> 00:15:02.999 William Murtaugh: the primary and backup, instruments that you'll be using. So the threshold for backup instruments, the document requirements are slightly lower. We don't require, the actual validation for your backup instruments. 105 00:15:03.470 --> 00:15:18.289 William Murtaugh: what we do require is that you have the package insert, just so we can verify that information, and then if there's FDA or CE status, particularly FDA, that you are providing 106 00:15:18.320 --> 00:15:24.509 William Murtaugh: documentation of that, that FDA status. So that way we can verify, 107 00:15:25.290 --> 00:15:44.070 William Murtaugh: you know, what the status is, basically. For some of our PALS, we have certain requirements, that, some methods must be FDA approved. For example, your, you know, your urine pregnancy test, so we would want to verify that, that the FDA status, 108 00:15:44.970 --> 00:15:46.270 William Murtaugh: is available. 109 00:15:47.600 --> 00:15:51.250 Kathie Ferbas: Will, let's pause for a second and see if there are any questions. 110 00:15:56.940 --> 00:15:58.070 Kathie Ferbas: Anybody? 111 00:15:58.640 --> 00:16:00.360 Kathie Ferbas: Need clarification? 112 00:16:00.900 --> 00:16:03.160 Kathie Ferbas: Or something to be repeated in Portuguese. 113 00:16:07.370 --> 00:16:15.260 Grace Aldrovandi: So, in brief, if you don't have anything in my lab, you're going to ask for, an account. 114 00:16:15.400 --> 00:16:30.280 Grace Aldrovandi: And then you're gonna go in here to enter in all the instruments that you use, so you would gather up all the data, the package inserts, etc, and then you'll just go through and upload, as Will has shown you. 115 00:16:31.900 --> 00:16:44.160 Grace Aldrovandi: And so then it'll all be there, it'll be there forever. And don't forget, you will have access to this, so you will be able to provide this to any auditor or inspector. 116 00:16:45.350 --> 00:17:01.980 Kathie Ferbas: And so, even if you have already provided this documentation to NICHD in the past, we're going to ask you to upload it into our system. We work very closely with PSMILE to, review the validations, and 117 00:17:02.330 --> 00:17:09.479 Kathie Ferbas: We may ask… we may… well, they may ask for additional information beyond what you have provided to us. 118 00:17:09.619 --> 00:17:17.230 Kathie Ferbas: There will be a back-and-forth exchange with P-Smile as well. Again, even if you've already had approval to use this previously. 119 00:17:17.460 --> 00:17:25.220 Kathie Ferbas: we're going to be starting from the beginning. You don't have to revalidate, but you need to give us what you've done, and then if P-Smile 120 00:17:25.700 --> 00:17:30.439 Kathie Ferbas: requests additional information, you will provide them with the additional information that they request. 121 00:17:34.900 --> 00:17:46.689 William Murtaugh: Yes, thank you both. And again, the validations are going to all be tied to the PALS, which is why we have you… you go through this process, first, and why I wanted to show it to you first. So… 122 00:17:47.390 --> 00:17:51.000 William Murtaugh: Next, I'll show you the… what the PAL… the MyPal will look like. 123 00:17:51.130 --> 00:17:55.379 William Murtaugh: I'm going to use this A5321 as an example. 124 00:17:56.280 --> 00:17:58.319 William Murtaugh: So again, you just select load. 125 00:18:01.270 --> 00:18:11.560 William Murtaugh: And the pal… the overall, you know, template you should be very familiar with. You know, you list the survey grouping, then each of the individual analytes below. 126 00:18:11.680 --> 00:18:18.239 William Murtaugh: You know, requirements for both a primary and a backup for each analyte. 127 00:18:19.660 --> 00:18:30.340 William Murtaugh: So, here, for example, we'll just take the first one, albumin. So, primary, selecting each of these pencil icons will give you the list. So for the lab. 128 00:18:30.570 --> 00:18:38.489 William Murtaugh: If you… first, you would select the lab that's doing the testing. So there, you know, it might be a multiple 129 00:18:38.490 --> 00:18:51.550 William Murtaugh: laboratories, depending on each lab's capacity for a given test. So you would select the lab that's applicable. If you're the one filling out the PAL, you would complete it for the analytes that your laboratory is expected to do testing for. 130 00:18:52.830 --> 00:19:03.010 William Murtaugh: So here, you know, we have Fiat Cruise. Once FIA Cruise is selected, then remember, as we said, you know, the validations that you've sent us, instrument method. 131 00:19:03.150 --> 00:19:10.199 William Murtaugh: Once you select the pencil, everything that has been validated and approved within my lab will be listed. 132 00:19:10.370 --> 00:19:17.809 William Murtaugh: So, you just have to identify which you'll be using as your primary for that study. 133 00:19:18.290 --> 00:19:19.660 William Murtaugh: and select it. 134 00:19:20.580 --> 00:19:28.450 William Murtaugh: And then it will fill out the row for you there. And so you would do that for, you know, for every analyte, required on the PAL. 135 00:19:30.620 --> 00:19:36.079 William Murtaugh: So hopefully, if you… again, if you've done everything up front, this should be a pretty simple process. 136 00:19:42.900 --> 00:19:58.440 William Murtaugh: And so, yellow, will indicate if there's anything, any recent changes from the last time you filled out the PAL. Those will be highlighted in yellow, for you to, you know, identify, ensure that, you know, the accuracy of those changes, before you're 137 00:19:58.640 --> 00:19:59.890 William Murtaugh: Resubmitting. 138 00:20:03.630 --> 00:20:12.710 William Murtaugh: So once the PAL is completed to, you know, to your satisfaction, there's a formal submission, so at the hamburger menu at the top. 139 00:20:14.970 --> 00:20:17.409 William Murtaugh: You would submit to the lab center. 140 00:20:19.160 --> 00:20:23.739 William Murtaugh: So, I'm not gonna submit this, yet, but it'll just give you a reminder 141 00:20:24.010 --> 00:20:39.940 William Murtaugh: you know, ensure that everything has been validated successfully, you have your EQA in place before you submit it. Because again, the lab center specialist that's been assigned to review your PAL is going to be looking for your EQA and proper validation. 142 00:20:40.050 --> 00:20:42.929 William Murtaugh: So, this is just a reminder. 143 00:20:43.800 --> 00:20:46.710 William Murtaugh: To ensure, before you submit it, all of that is in place. 144 00:20:49.160 --> 00:20:53.229 William Murtaugh: The two other components of the PAL that I wanted to, 145 00:20:53.390 --> 00:20:59.339 William Murtaugh: Make you aware of, which, are… A little different within, 146 00:20:59.500 --> 00:21:02.229 William Murtaugh: Our lab center is the specimen 147 00:21:02.520 --> 00:21:11.719 William Murtaugh: flowchart, or what we're now calling the specimen query sheet, and your HIV algorithm. So those two documents, 148 00:21:12.920 --> 00:21:20.350 William Murtaugh: are uploaded along with the PAL, and so they'll actually be required. If they're not submitted, the system will 149 00:21:20.510 --> 00:21:22.419 William Murtaugh: Remind you, it'll say… 150 00:21:22.590 --> 00:21:36.579 William Murtaugh: there'll be an error that says, no, no specimen flow chart has been uploaded, or no HIV algorithm has been uploaded. So ensure that you've also included these documents as well. The specimen query sheet. 151 00:21:36.750 --> 00:21:38.370 William Murtaugh: I'm going to… 152 00:21:48.610 --> 00:21:50.470 William Murtaugh: Just have an example open. 153 00:21:59.060 --> 00:22:00.810 William Murtaugh: Here, actually, I'll just open this one. 154 00:22:10.790 --> 00:22:13.509 William Murtaugh: So this is the, the specimen, 155 00:22:13.820 --> 00:22:25.519 William Murtaugh: handling query sheet. So previously, you may be used to, kind of a flow chart style. What we've done is reduce this basically down to a few questions. What we… 156 00:22:25.690 --> 00:22:42.389 William Murtaugh: want to know from this is the processing and storage information. So the PAL doesn't necessarily capture, it just captures maybe the samples you'll be collecting and storing, the testing that you'll be done, but sometimes, you know, if there's local processing, 157 00:22:42.430 --> 00:22:51.069 William Murtaugh: for example, PK testing that needs to be processed quickly might be done at the site. That's information that we want to capture here. 158 00:22:51.200 --> 00:22:58.440 William Murtaugh: So… You know, information, just like the lab name, who is processing it, 159 00:22:58.940 --> 00:23:02.539 William Murtaugh: The type of sample that's going to be processed, 160 00:23:02.830 --> 00:23:15.709 William Murtaugh: And then also the chain of custody of that sample. Is there a short-term location where you'll be storing it? Will you be shipping it to a biorepository? And then what will be the end testing 161 00:23:15.710 --> 00:23:25.940 William Murtaugh: laboratory for those samples, and then any frequencies of shipment. This is… is an exercise for you to go through and make sure that you understand, 162 00:23:26.800 --> 00:23:29.929 William Murtaugh: How the samples are being handled, basically, all the way through. 163 00:23:30.070 --> 00:23:38.440 William Murtaugh: To the… to the final testing lab. And that way, if there's any questions, we have this document that we can reference, 164 00:23:38.600 --> 00:23:39.490 William Murtaugh: about… 165 00:23:39.650 --> 00:23:46.510 William Murtaugh: you know, again, about where the samples are being processed and stored. So this would include PK, PBMCs. 166 00:23:47.050 --> 00:24:06.040 William Murtaugh: For some of our TB studies, there are certain sputum samples that need to be processed differently, so those might be included. So again, anything that would need to be specially processed and stored, we would want to have you complete information about that process here on this sheet. 167 00:24:12.710 --> 00:24:15.979 Kathie Ferbas: Any questions on those before you move on, Will? 168 00:24:21.540 --> 00:24:22.490 Kathie Ferbas: Okay. 169 00:24:25.350 --> 00:24:27.930 William Murtaugh: And then the HIV algorithm, 170 00:24:28.380 --> 00:24:32.430 William Murtaugh: That should be pretty familiar with, with you. 171 00:24:34.170 --> 00:24:38.159 William Murtaugh: Just an example of what theirs looks like. 172 00:24:51.560 --> 00:24:54.109 William Murtaugh: So again, this is just a flow chart, 173 00:24:54.590 --> 00:25:00.779 William Murtaugh: of the study-specific requirements, for HIV testing for… for… 174 00:25:02.080 --> 00:25:15.279 William Murtaugh: each of the labs. So, you know, identifying what is going to be your first test, your screening test, your confirmatory test, and how you would handle any positives, negatives, discordant results. 175 00:25:15.510 --> 00:25:17.240 William Murtaugh: Etc. 176 00:25:19.600 --> 00:25:31.359 William Murtaugh: So, you can submit this as, you know, as a PowerPoint, Excel, Word document, whatever way works for you to best describe your HIV algorithm. 177 00:25:31.740 --> 00:25:33.560 William Murtaugh: It's fine with us, and… 178 00:25:33.870 --> 00:25:38.469 William Murtaugh: You would just upload it again there within the documents, tab of my lab. 179 00:25:51.700 --> 00:25:52.830 William Murtaugh: Right, so… 180 00:25:53.920 --> 00:26:00.279 William Murtaugh: Those are the main components of… that make up my lab. Again, if, you know, there's… there's, 181 00:26:01.580 --> 00:26:19.029 William Murtaugh: various details about how you, you know, different buttons that you would need to press, where to find things. So I would refer you to those training videos, that you can watch as many times as you want. Use them as you're going through my lab to kind of help you navigate, 182 00:26:20.930 --> 00:26:30.420 William Murtaugh: So I will… I will stop there and ask if there are any… questions… Comments. 183 00:26:33.840 --> 00:26:39.530 William Murtaugh: Anything else that… Kathy, Grace, Sarah, others want to add? 184 00:26:43.320 --> 00:26:50.810 William Murtaugh: If not, I will turn it over to Sarah, to go over the laboratory activation checklist component. 185 00:26:54.440 --> 00:26:56.110 Sara Zabih: Good afternoon, everyone. 186 00:26:57.130 --> 00:27:07.159 Sara Zabih: I'll be, talking about the lab activation checklist. As Will covered, completion of MyPal is one of the components toward lab approval. 187 00:27:07.440 --> 00:27:25.349 Sara Zabih: Another main component is completing a lab activation checklist, which is a document that aids in tracking of the progress of a laboratory that will support a site for the study, and it outlines all the requirements that must be completed prior to receiving a laboratory approval for the study. 188 00:27:26.600 --> 00:27:31.999 Sara Zabih: I'll be showing an example, but when a study is 189 00:27:32.140 --> 00:27:36.999 Sara Zabih: finalized, when the protocol is finalized and LPC is finalized. 190 00:27:37.590 --> 00:27:45.410 Sara Zabih: There will be, a welcome email that will be released by the lab center specialist assigned to this study. 191 00:27:45.810 --> 00:27:49.900 Sara Zabih: The welcome email will initiate the lab approval process. 192 00:27:50.640 --> 00:27:55.530 Sara Zabih: I will be showing an example of a lab approval email. 193 00:27:55.690 --> 00:27:59.500 Sara Zabih: That the site laboratory personnel will receive. 194 00:28:00.180 --> 00:28:03.040 Sara Zabih: Just want to make sure I have it on. 195 00:28:04.180 --> 00:28:07.209 Sara Zabih: Can you see my screen? Does everyone can see my screen? 196 00:28:07.660 --> 00:28:08.350 Vanessa Pinheiro: Yes. 197 00:28:08.940 --> 00:28:09.760 Sara Zabih: Perfect. 198 00:28:10.160 --> 00:28:17.220 Sara Zabih: This is an example, again, from the IPIC site that graciously approved to show this example. 199 00:28:17.840 --> 00:28:29.670 Sara Zabih: You will receive a lab approval email, and in this lab approval email, there's going to be components that will be covering what will be required to complete a lab activation checklist. 200 00:28:30.110 --> 00:28:35.700 Sara Zabih: In the email, you have access to who is your lab center specialist on that study. 201 00:28:36.790 --> 00:28:49.540 Sara Zabih: And what components need to be completed? This is an example, so as Will talked about, MyPal needs to be completed, all the specimen query-shade HIV algorithms need to be completed on this. 202 00:28:49.580 --> 00:28:58.089 Sara Zabih: And as soon as the PAL and associated documents are completed, LC will review and will forward it to Declaude for sign-off. 203 00:28:58.750 --> 00:29:05.979 Sara Zabih: There is going to be supporting documentation that is required for the laboratories to submit to MyLab Central. 204 00:29:06.090 --> 00:29:17.729 Sara Zabih: database, which is the current signed and dated Laboratory Director CV. So all lab… site labs, they need to submit this document via my LabCentral database. 205 00:29:18.150 --> 00:29:24.660 Sara Zabih: Well, I'm not sure if you covered where the supporting documents were able to be submitted. 206 00:29:27.000 --> 00:29:30.020 Sara Zabih: Via, where you were signed off. 207 00:29:30.780 --> 00:29:33.369 Sara Zabih: Would you be sharing that, please? 208 00:29:34.030 --> 00:29:36.909 Sara Zabih: I don't have access to my… that helpful link. 209 00:29:37.930 --> 00:29:40.510 William Murtaugh: For the… I'm sorry, for what? 210 00:29:41.180 --> 00:29:46.499 Sara Zabih: And to just as a supporting document that the site labs can, submit via my lab. 211 00:29:46.500 --> 00:29:47.260 William Murtaugh: Sure, yeah. 212 00:29:48.390 --> 00:29:49.690 Sara Zabih: Really appreciate it. 213 00:29:49.690 --> 00:29:52.130 William Murtaugh: Yeah, let me share my screen again, sorry. 214 00:29:55.260 --> 00:29:55.950 William Murtaugh: Okay. 215 00:30:03.710 --> 00:30:06.189 William Murtaugh: Yep, so again, at the top, yeah, yep. 216 00:30:07.270 --> 00:30:08.330 Sara Zabih: Go ahead, go ahead, sorry. 217 00:30:10.660 --> 00:30:12.240 William Murtaugh: You want to talk through it, I can… 218 00:30:12.630 --> 00:30:21.169 Sara Zabih: Yes, so this is, as you log in, so under the supporting documents, you have an option to create a new document. 219 00:30:21.450 --> 00:30:22.490 Sara Zabih: And… 220 00:30:22.800 --> 00:30:31.209 Sara Zabih: You select the lab, you select the type, and then you can either create here, or, like, or you can just click on the create document. 221 00:30:32.450 --> 00:30:43.319 Sara Zabih: For the international sites, it will be the director's CV. You will choose the document type, you will choose the lab, whatever lab you're submitting the document for. 222 00:30:45.910 --> 00:30:52.860 Sara Zabih: And you need to name the document, you put the effective date, and the lab director name. 223 00:30:52.980 --> 00:30:57.579 Sara Zabih: And then you can upload, the document under the upload sign. 224 00:30:57.760 --> 00:30:59.540 Sara Zabih: And then you will submit. 225 00:30:59.810 --> 00:31:11.410 Sara Zabih: This document will come to our supporting document group. They will review it, and as soon as they approve, it will be added as a supporting document for the lab that you're submitting it to. 226 00:31:13.240 --> 00:31:14.530 Sara Zabih: Thank you so much, Will. 227 00:31:15.060 --> 00:31:16.620 Sara Zabih: Any questions? 228 00:31:17.540 --> 00:31:25.130 Grace Aldrovandi: So, Sarah, why don't you go back to the welcome email? Yes. And then maybe we can, if there aren't questions, we can just sort of summarize. 229 00:31:25.130 --> 00:31:43.790 Grace Aldrovandi: So, the first thing you're going to do is put in your whole laboratory inventory in then. Then the next thing you're going to do is fill out the MyPal, and it becomes very easy, because, you know, if you're going to use this analyzer as your primary and this as your secondary, you just click. 230 00:31:43.900 --> 00:32:02.310 Grace Aldrovandi: And all the information, the serial number, etc, will be put in place. And if you want to know, this welcome email that you get really outlines what you need to do before you can get activated. So the MyPal, which we went through, which is the biggest lift. 231 00:32:02.320 --> 00:32:13.220 Grace Aldrovandi: But don't forget, once you have put in your CBC machine, whatever, it will be there forever. And, you know, and that we've proved that it's validated, so you don't have to worry about that. 232 00:32:13.220 --> 00:32:24.479 Grace Aldrovandi: And then, you know, we have the study-specific handling, so you're just gonna, you know, sit down, with your team and just think, like, everything that's in the 233 00:32:24.520 --> 00:32:25.580 Grace Aldrovandi: the… 234 00:32:25.610 --> 00:32:36.809 Grace Aldrovandi: laboratory processing chart, where is it collected? Where is it being processed, where is it going to be sent? We've changed that to just a few questions, and you can just answer them. 235 00:32:36.830 --> 00:32:49.440 Grace Aldrovandi: The HIV testing algorithm, you know, you've always had to do, and we've tried to, again, you can fill it out in a PowerPoint or however, so we have that. 236 00:32:49.520 --> 00:32:53.519 Grace Aldrovandi: And so those are the key elements. And then supporting doc. 237 00:32:53.520 --> 00:33:18.480 Grace Aldrovandi: It's really the laboratory director's CV, and unless the laboratory director changes, again, it's there all the time. And if you ever need any of these documents, again, for an inspection, or you have people changing, you know, there's a million stories, you can always log in, and you can always download these. And, so it does seem, you know, like a lot of stuff 238 00:33:18.480 --> 00:33:21.690 Grace Aldrovandi: at the beginning, and it is, but… 239 00:33:21.800 --> 00:33:36.800 Grace Aldrovandi: It's all there in one place, and if you need help, you know, uploading or anything, you know, we're available, but also, you know, I think the little TikTok bites 240 00:33:36.920 --> 00:33:55.039 Grace Aldrovandi: of training that you have, that we have on the website should be, you know, helpful, because we show you, and we talk, and you can always download the transcript, and you can translate into Portuguese if you have lab staff who, you know, aren't as fluent in 241 00:33:55.040 --> 00:34:02.670 Grace Aldrovandi: Portuguese. And if you have any questions, you can ask them in Portuguese. So, Vanessa. 242 00:34:02.670 --> 00:34:10.560 Grace Aldrovandi: can show off that she can speak in her native tongue. 243 00:34:10.560 --> 00:34:14.290 Vanessa Pinheiro: Hi, everybody, yes, let me know if I can help, I'm here. 244 00:34:14.730 --> 00:34:16.350 Grace Aldrovandi: You can say it in Portuguese. 245 00:34:16.840 --> 00:34:22.840 Vanessa Pinheiro: doki. 246 00:34:24.380 --> 00:34:28.630 Grace Aldrovandi: That's just to prove that she really does speak, and she's not a chatbot. 247 00:34:30.369 --> 00:34:32.349 Vanessa Pinheiro: From Mina's your eyes. 248 00:34:33.600 --> 00:34:38.190 Grace Aldrovandi: Well, that's good, because I'm sure that was the number one question that people had. 249 00:34:38.340 --> 00:34:40.900 Vanessa Pinheiro: Yes, because of the accent. 250 00:34:45.139 --> 00:34:45.659 Sara Zabih: Okay. 251 00:34:46.669 --> 00:34:50.699 Sara Zabih: So if there is no question, I can continue with the rest of the welcome email. 252 00:34:51.779 --> 00:35:10.169 Sara Zabih: So, the next component would be if you can provide the name and contact information of the site IOR designee as soon as you receive the welcome email. This will help expedite the process of sending the attestation items that the IOR designee will need to sign. 253 00:35:10.369 --> 00:35:14.789 Sara Zabih: as outlined here, and also on the checklist, which I'll show, 254 00:35:15.359 --> 00:35:24.059 Sara Zabih: The IR designee will need to sign and attest via DocuSign that these components are available at the site lab 255 00:35:24.649 --> 00:35:30.209 Sara Zabih: And, all of the components are gonna be, covered by the IOR. 256 00:35:30.509 --> 00:35:31.899 Sara Zabih: And the site lapse. 257 00:35:32.419 --> 00:35:34.119 Sara Zabih: The next component is gonna… 258 00:35:34.120 --> 00:35:35.800 Grace Aldrovandi: Sarah, what's the IOR? 259 00:35:36.100 --> 00:35:39.210 Sara Zabih: Investigator of record, or designee. 260 00:35:40.340 --> 00:35:52.330 Grace Aldrovandi: So that's going to be the PI, of the proto… of, you know, of your site, or sometimes for the larger sites, the PI may designate, somebody else to be in charge of that protocol. 261 00:35:54.450 --> 00:36:03.509 Sara Zabih: And this is gonna… this is an example of the attestation that will be sent to the site labs for the investigator record or designee to sign. 262 00:36:03.750 --> 00:36:09.180 Sara Zabih: And we'll provide the lab names that are participating for the site protocol, and… 263 00:36:09.390 --> 00:36:26.879 Sara Zabih: All the components, including the SOP or table of content, is available. The no more references… ranges are available at the lab. There is at least two personnel having IOTA shipping certifications, and appropriate site labs have completed GCLP training. 264 00:36:26.880 --> 00:36:34.120 Sara Zabih: If there is a PK component to the protocol, the designated staff have completed the PK tutorial. 265 00:36:34.170 --> 00:36:45.779 Sara Zabih: And the site labs are responsible to updating the distribution list, or MIS, which is for the ACTG, or to FHI for the impact protocols. 266 00:36:46.770 --> 00:37:03.270 Sara Zabih: And if there is import or contractual agreements, MTAs, export permits are in place for any testing laboratories, for the primary and backup laboratories. So these are the components that the IR designee will need to attest to. 267 00:37:03.350 --> 00:37:12.480 Sara Zabih: And this, again, this document will be sent via DocuSign, and it will be signed via DocuSign, and it will be part of your laboratory approval process. 268 00:37:13.980 --> 00:37:25.989 Sara Zabih: Another component for the lab approval is the satisfactory performance for your PT for the study analytes. This is going to be, for piece mile, IQA, VQA. 269 00:37:26.060 --> 00:37:34.709 Sara Zabih: And then there's going to be resolutions of any outstanding IRs or APs that need to be closed within the 30-day window. 270 00:37:34.910 --> 00:37:48.840 Sara Zabih: This is the main component that delays lab activation, so please pay attention to make sure that you're… as soon as you receive your IRs and APs, you will, close them within the window of 30 days. 271 00:37:49.560 --> 00:37:50.670 Sara Zabih: Or sooner. 272 00:37:52.150 --> 00:38:11.669 Sara Zabih: The MTAs are only applicable, this section of the welcome email is only applicable to the impact studies, and for ACTG, PMC is responsible for MTAs. But for impact studies, you will need to, submit a drafted MTA to the… 273 00:38:13.340 --> 00:38:22.200 Grace Aldrovandi: The NICHD sites will continue to have MTAs and be shipping to the Fisher repository. We're not changing that. 274 00:38:22.760 --> 00:38:23.220 Sara Zabih: Okay. 275 00:38:23.220 --> 00:38:27.640 Grace Aldrovandi: So, you already have, MTAs that Jack Moy oversees. 276 00:38:28.050 --> 00:38:30.940 Kathie Ferbas: But for new protocols going forward, for… 277 00:38:31.130 --> 00:38:36.620 Kathie Ferbas: NICHD sites that have transitioned to become protocol-specific NIAID sites. 278 00:38:37.460 --> 00:38:41.489 Kathie Ferbas: That's when we'll deal with MTAs, but for existing protocols, nothing will change. 279 00:38:42.210 --> 00:38:48.920 Kathie Ferbas: So, everybody's correct. There's little pieces of it. Vanessa, maybe you want to say that in Portuguese, because it's confusing. 280 00:38:49.050 --> 00:38:57.310 Kathie Ferbas: So, let me say it, and you can do one at a time. If the study is already open and you have an MTA, we do not need a new MTA. 281 00:38:58.020 --> 00:39:01.360 Vanessa Pinheiro: Okay, see… Cesentandeero. 282 00:39:01.630 --> 00:39:07.629 Vanessa Pinheiro: ja ta contessen, nao preciso. 283 00:39:09.050 --> 00:39:12.610 Kathie Ferbas: For a new protocol, any… 284 00:39:12.610 --> 00:39:13.550 Vanessa Pinheiro: Nova prototy. 285 00:39:13.550 --> 00:39:21.039 Kathie Ferbas: NIAID or NIAID protocol-specific site, so a core site or a protocol-specific site. New protocol. 286 00:39:21.560 --> 00:39:24.130 Kathie Ferbas: We will be responsible for collecting MTAs. 287 00:39:24.990 --> 00:39:28.700 Vanessa Pinheiro: Ai precisa, se founder tendinasite. 288 00:39:29.120 --> 00:39:30.969 Vanessa Pinheiro: How come I do it sobre es? 289 00:39:32.520 --> 00:39:39.110 Kathie Ferbas: for NICHD sites that are not transitioning to NIAID, For new protocols. 290 00:39:40.360 --> 00:39:46.240 Kathie Ferbas: Even though we are doing lab activations, your MTAs will still go through Westat. 291 00:39:49.810 --> 00:39:51.999 Vanessa Pinheiro: Yes, I think they got it. 292 00:39:52.330 --> 00:39:52.990 Kathie Ferbas: Okay. 293 00:39:53.260 --> 00:39:58.530 Vanessa Pinheiro: Yes. Se esta alguma pergunta sobre so, gente que la tacienda tao… tao clar, parao. 294 00:39:59.630 --> 00:40:00.080 Vanessa Pinheiro: What's found? 295 00:40:00.500 --> 00:40:09.410 Deborah Silva: retaine. 296 00:40:10.240 --> 00:40:12.379 Vanessa Pinheiro: Os saides que tenia? 297 00:40:12.560 --> 00:40:14.550 Deborah Silva: achibos. 298 00:40:16.110 --> 00:40:18.369 Vanessa Pinheiro: Protocol is achievable. 299 00:40:19.050 --> 00:40:26.330 Deborah Silva: Si ele es precisamo incui, as informacoes do melabio nao e necessario so essa parte non fo claro pragm. 300 00:40:26.330 --> 00:40:31.079 Vanessa Pinheiro: Okay, Kathy, if the site already has… is already active? 301 00:40:31.400 --> 00:40:33.309 Vanessa Pinheiro: Does it need it or not? 302 00:40:33.560 --> 00:40:36.709 Kathie Ferbas: No new MTAs are needed if they're already active. 303 00:40:36.950 --> 00:40:41.049 Vanessa Pinheiro: Yeah, so this… so this one is already active in her case, so no… 304 00:40:41.520 --> 00:40:43.210 Kathie Ferbas: No new. No new. 305 00:40:44.080 --> 00:40:45.069 Kathie Ferbas: It's good. 306 00:40:45.270 --> 00:40:47.659 Vanessa Pinheiro: Okay, tenderam tano precisa. 307 00:40:47.660 --> 00:40:48.940 Deborah Silva: team, pretty good. 308 00:40:54.710 --> 00:40:55.530 Kathie Ferbas: Go ahead, Sarah. 309 00:40:56.520 --> 00:41:03.630 Sara Zabih: So, and in the welcome email, there's gonna be, if information regarding University of Washington. 310 00:41:03.630 --> 00:41:19.999 Sara Zabih: If, for any reason, the site labs need to send samples to University of Washington, there is a detailed information captured in the welcome email that, will be helpful and provide, like, the exact details that need to be done for University of Washington. 311 00:41:21.620 --> 00:41:24.500 Kathie Ferbas: Do you want to explain why? University of Washington? 312 00:41:25.710 --> 00:41:31.939 Sara Zabih: It's the… for the central laboratory testing, it's… do you want me to go into details, or… 313 00:41:31.940 --> 00:41:43.750 Kathie Ferbas: for… if there is testing, if there's protocol testing that you cannot either do in your lab, or you need a backup laboratory, the University of Washington is able to 314 00:41:43.860 --> 00:41:51.470 Kathie Ferbas: In almost every case, serve as either the primary testing site for you, or as a backup laboratory for you. 315 00:41:53.060 --> 00:42:11.759 Grace Aldrovandi: So, sometimes in the past, you know, people have used Quest and other laboratories, but because of the MTA requirements by the Brazilian government, that has not been possible in recent years, so… 316 00:42:11.760 --> 00:42:24.240 Grace Aldrovandi: We use… you don't have to use the University of Washington, it would have to be a CLIA-approved or a network-approved lab, but they are good at getting, MTAs through. 317 00:42:24.240 --> 00:42:35.510 Grace Aldrovandi: For some ACTG protocols, they are the central testing lab, so you have to send them to the University of Washington. 318 00:42:35.660 --> 00:42:51.140 Grace Aldrovandi: And, we have detailed ways on how to send it, because if you register with the University of Washington, then they will send you the results electronically, and it'll be much quicker and easier. 319 00:42:52.510 --> 00:42:58.929 Grace Aldrovandi: And, so that's the story, but I don't think for any of the protocols. 320 00:42:59.390 --> 00:43:03.019 Grace Aldrovandi: Coming up, Kathy? Is, is UW, 321 00:43:04.860 --> 00:43:08.220 Grace Aldrovandi: gonna be doing them. I can't… 322 00:43:08.500 --> 00:43:12.390 Kathie Ferbas: Yes, quite a few, for ACTG. 323 00:43:12.390 --> 00:43:14.560 Grace Aldrovandi: That these folks would be using. 324 00:43:14.790 --> 00:43:28.570 Kathie Ferbas: well, if they participate in ACTG studies only, but this… the point is, is we often have things that you need a backup laboratory for. If you cannot identify one, we will try to help you find one in country. 325 00:43:28.770 --> 00:43:37.799 Kathie Ferbas: as a kind of last resort, you can always use the University of Washington, if the turnaround time is acceptable. So we will work with you on that. 326 00:43:37.970 --> 00:43:40.710 Kathie Ferbas: Nana, did you have a question, or did we answer it? 327 00:43:43.160 --> 00:43:48.459 Naana Cleland: No, so I think I'll wait till, I'll wait till, Sarah's done. 328 00:43:48.860 --> 00:43:49.590 Kathie Ferbas: Okay. 329 00:43:50.850 --> 00:43:54.999 Naana Cleland: Yeah, and then I can ask at the end of the presentation. Okay. Thank you. 330 00:43:57.490 --> 00:44:04.050 Sara Zabih: Again, in the welcome email, we also have our website information, which has all the helpful and training videos. 331 00:44:04.320 --> 00:44:18.469 Sara Zabih: And if, during this process, at any time, if you have any questions, you have your laboratory center representative listed for that study, so please reach out to them, or reach out to any of us on this call, as mentioned. 332 00:44:19.450 --> 00:44:24.610 Sara Zabih: So I'm gonna now demonstrate the… Lab Activation Checklist? Yes. 333 00:44:24.610 --> 00:44:30.409 Grace Aldrovandi: Sarah, just one thing. The other thing is that we have regular, what we call, office hours. 334 00:44:30.870 --> 00:44:36.140 Grace Aldrovandi: By region, so you can always log on. It's… 335 00:44:36.250 --> 00:44:54.859 Grace Aldrovandi: better, you know, ideally, you could let us know in advance, I have a question about protocol XYZ, and we would make sure that that protocol specialist was on the call, but generally speaking, so you can reach out to us directly from the invitation letter, but we also have 336 00:44:54.900 --> 00:44:58.989 Grace Aldrovandi: Office hours that you can come, and ask questions to. 337 00:44:59.390 --> 00:45:03.030 Kathie Ferbas: And you can always submit your questions on our website. 338 00:45:03.760 --> 00:45:06.159 Kathie Ferbas: If we can answer them in real time, we will. 339 00:45:06.290 --> 00:45:10.230 Kathie Ferbas: Otherwise, we will have somebody on office hours for you. 340 00:45:15.410 --> 00:45:16.230 Sara Zabih: be able to… 341 00:45:16.720 --> 00:45:18.420 Grace Aldrovandi: Okay. Sorry, Sarah, go ahead. 342 00:45:18.420 --> 00:45:27.990 Sara Zabih: So yeah, just want to say, like, this is under… on our website, it's under FAQs, this is a website comments and questions. If you can't find it, submit your questions here. 343 00:45:32.880 --> 00:45:42.950 Sara Zabih: So this is an example of our laboratory activation checklist. It will provide the information for your protocol, the site name, site contacts, and lab contacts. 344 00:45:43.030 --> 00:45:57.680 Sara Zabih: When you receive the initial welcome email, if your site and lab contacts are not listed, please reply to the welcome email and provide the information for your site and lab contacts, as well as IOR, as I mentioned previously. 345 00:45:58.380 --> 00:46:11.529 Sara Zabih: It will list your laboratory center contacts as well. As soon as you complete your MyPals, and the PAL is approved, all the associated testing laboratory is going to be listed under here. 346 00:46:11.530 --> 00:46:21.709 Sara Zabih: And all the specialty laboratories, for example, if it's a PK lab, it will be mentioned here, and for the analyte that is going to be… the test is going to be performed at. 347 00:46:23.930 --> 00:46:36.990 Sara Zabih: As soon as, again, my PAL and associated documents are completed, the status is going to show complete with the date that the declaw has approved the PAL for these first three components. 348 00:46:37.890 --> 00:46:56.439 Sara Zabih: This, again, the satisfactory scores for study analytes, by… which is monitored by PSMILE, VQA, and IKA for lymphocyte subsets, or PBMC, are going to be mentioned as completed here with the most recent, EQA dates, PT scoring dates. 349 00:46:57.190 --> 00:47:06.019 Sara Zabih: The resolution of action items and IRs are going to be completed, hopefully as it's completed within the 30 days. 350 00:47:06.160 --> 00:47:16.449 Sara Zabih: Again, as I mentioned, this is the main component that delays laboratory approvals. Please work on closing your action items and IRs as soon as you receive them. 351 00:47:17.630 --> 00:47:28.359 Sara Zabih: When you submit your laboratory director's CV, it will pull automatically from MyLab Central, and it will show the name of the lab director and the date that the document was signed. 352 00:47:29.810 --> 00:47:41.659 Sara Zabih: If your protocol requires a PBMC or a Leukopac processing, the satisfactory score from the IQA is going to be showing here as the, as is acceptable and approved. 353 00:47:43.230 --> 00:47:56.550 Sara Zabih: These are the items as, was… is covered by the laboratory attestation. As soon as the attestation is signed, the document will be added to my lab, and the status is going to show complete for all these items. 354 00:47:58.810 --> 00:48:09.590 Sara Zabih: And when we… as soon as all the items on this lab activation is completed, the lab center will review, and then approved will send it for… for DCLAD for approval. 355 00:48:10.230 --> 00:48:27.339 Sara Zabih: Throughout this process, you will receive notifications from Lab Center representatives, and they will provide feedback of where you stand with completing your laboratory activation items. And if you have any questions, please feel free to reach out to them. 356 00:48:28.900 --> 00:48:35.639 Sara Zabih: As soon as the lab approval, is granted by DCLAG for the lab activation checklist. 357 00:48:36.040 --> 00:48:43.660 Sara Zabih: An email will be sent to the site labs, and they will receive a lab approval email. Basically, in this email. 358 00:48:43.740 --> 00:48:58.490 Sara Zabih: You have a finalized PAL document, you have your PAL-associated documents, declawed signed lab activation checklist, your attestation that was signed via DocuSign, and a lab approval email. 359 00:48:58.570 --> 00:49:06.550 Sara Zabih: This email will serve as… for your record that you have a complete, signed-off laboratory activation checklist. 360 00:49:07.500 --> 00:49:19.550 Sara Zabih: And you will work… as soon as you receive this, this is the laboratory readiness that is completed, then your site will be ready to participate as soon as they receive a site activation. 361 00:49:23.500 --> 00:49:25.100 Sara Zabih: Any questions? 362 00:49:25.340 --> 00:49:28.900 Kathie Ferbas: Sarah, can I show what a completed activation checklist looks like? 363 00:49:29.220 --> 00:49:29.920 Sara Zabih: Yes. 364 00:49:34.990 --> 00:49:36.929 Sara Zabih: Just wanted to make sure that's the one. 365 00:49:39.120 --> 00:49:43.660 Sara Zabih: So… This is the components that we're missing from, 366 00:49:44.090 --> 00:49:50.180 Sara Zabih: the first checklist that I was showing, it pulls all the associated laboratories. 367 00:49:52.380 --> 00:50:00.879 Sara Zabih: all the statuses are going to be complete with the information of when the… for the PAL document, when it was finalized and signed. 368 00:50:03.460 --> 00:50:21.020 Sara Zabih: All the performance evaluations for your PTs are going to be completed for any laboratory that is participating. For example, this site has fear crews, HNSC, NHCNI. They all have completed this, and they have passed successfully 2 out of 3 rounds. 369 00:50:22.070 --> 00:50:25.559 Sara Zabih: Same applies for VQA and IQA items. 370 00:50:26.560 --> 00:50:36.019 Sara Zabih: all the items for the IRs and APs are going to be completed. That means, like, they… there's no investigation records, and the action plans have been closed. 371 00:50:38.660 --> 00:50:46.130 Sara Zabih: the sign and laboratory director CV for the participating laboratories are Added to the checklist. 372 00:50:48.700 --> 00:51:00.660 Sara Zabih: If there is a P… well, this is the old one, we're not covering that. If there is a PBMC, the PBMC is also… the PT is showing, and it's completed. 373 00:51:00.930 --> 00:51:08.179 Sara Zabih: All the attestation items are completed with the date that the attestation was signed by the IOR. 374 00:51:11.440 --> 00:51:17.850 Sara Zabih: Then, at the end, you have the laboratory approval signature and date, and the declawed approval signature and date. 375 00:51:18.460 --> 00:51:22.170 Sara Zabih: And this is your finalized, lab activation checklist. 376 00:51:23.150 --> 00:51:32.410 Kathie Ferbas: And this should be stored in your binder with all of your documents, so that if an auditor comes and asks, you can provide this, and all the information is there. 377 00:51:32.540 --> 00:51:34.770 Kathie Ferbas: Complete audit trail on our end. 378 00:51:35.920 --> 00:51:40.979 Grace Aldrovandi: But if somebody forgets to do it, you can always go into MyLab and download it. 379 00:51:44.100 --> 00:51:53.399 Grace Aldrovandi: So, but, you know, it's best that, you know, print it out and put it in your regulatory binder, because the auditors will want to see it. 380 00:51:59.430 --> 00:52:00.490 Kathie Ferbas: Any questions? 381 00:52:05.760 --> 00:52:06.650 Kathie Ferbas: Nana. 382 00:52:07.130 --> 00:52:07.880 Naana Cleland: Okay. 383 00:52:08.050 --> 00:52:12.360 Naana Cleland: So, I wanted to just clarify, for the labs. 384 00:52:12.590 --> 00:52:21.500 Naana Cleland: And this is specifically for impact. If they've already been to lab activation, through NICHD, what's that? 385 00:52:21.500 --> 00:52:34.879 Naana Cleland: I just want to ex… if you can provide some explanation in terms of what's gonna happen, because they will be going through another, minimal process, but they will have to be, get a lab activation through, 386 00:52:35.130 --> 00:52:38.970 Naana Cleland: the DLC. Is that… that's gonna be the case, correct? 387 00:52:39.490 --> 00:52:40.320 Kathie Ferbas: Correct. 388 00:52:40.750 --> 00:52:51.279 Naana Cleland: Okay, so I thought we should let them… the labs know, in terms of if you already have an activation through NICHD, and now that you've transitioned to 389 00:52:51.340 --> 00:53:02.300 Naana Cleland: oversight with LC, you will be getting another lab activation, and it won't be that extensive, hopefully, because you should have some of the key elements in place. 390 00:53:02.520 --> 00:53:03.420 Naana Cleland: Thank you. Bye. 391 00:53:03.660 --> 00:53:10.569 Kathie Ferbas: Yes, but what we won't do is, if while you are getting your activation, you can continue to participate. 392 00:53:10.830 --> 00:53:16.899 Kathie Ferbas: In the, in the protocol, under your activations from NICHD. 393 00:53:18.230 --> 00:53:25.470 Kathie Ferbas: We don't want you to stop having visits while we're getting the documents. However, if you do not reply to us and do not 394 00:53:25.630 --> 00:53:27.619 Kathie Ferbas: Work quickly to get this done. 395 00:53:27.980 --> 00:53:30.039 Kathie Ferbas: We may have a different conversation. 396 00:53:30.910 --> 00:53:31.620 Grace Aldrovandi: Yeah. 397 00:53:31.620 --> 00:53:34.450 Naana Cleland: And just… sorry, go ahead, Grace. 398 00:53:34.450 --> 00:53:49.120 Grace Aldrovandi: Oh, well, I was gonna say, the reason for this is that we really want to collect all the documents in our system so that they're readily available, and we don't have to rely on an email that was sent to one of your staff. 399 00:53:49.160 --> 00:53:59.370 Grace Aldrovandi: you know, 17 months ago, and that staff has left, or you can't find it. And this way, when you do new protocols, everything will already be in place for you. 400 00:54:00.620 --> 00:54:01.150 Sara Zabih: been… 401 00:54:01.150 --> 00:54:03.380 Naana Cleland: And I… Sorry. 402 00:54:03.660 --> 00:54:04.370 Sara Zabih: Sorry, I won't. 403 00:54:04.370 --> 00:54:06.449 Naana Cleland: And I think what is… go ahead. 404 00:54:07.500 --> 00:54:08.030 Naana Cleland: Comment. 405 00:54:08.630 --> 00:54:24.790 Naana Cleland: I think what is important is, in terms of the sites that were transitioned from NICHD to, dates protocol-specific, the labs that were… these sites did not have any participants on study. So, I will hope that 406 00:54:24.790 --> 00:54:30.150 Naana Cleland: The new studies that these sites were enrolling in, activated for. 407 00:54:30.150 --> 00:54:47.079 Naana Cleland: and they haven't really enrolled, will not… will translate the same to the labs, meaning that for those specific studies that will require LC to provide new activation for, they hopefully don't have any participants that they are testing for. So hopefully that will make it easier. 408 00:54:47.370 --> 00:54:48.330 Naana Cleland: Thanks. 409 00:54:50.400 --> 00:54:54.669 Sara Zabih: And Kathy, do you want to talk about the APs and IRs that are pending still? 410 00:54:56.190 --> 00:55:02.729 Kathie Ferbas: I think Nana has already sent out instructions, as has NICHD, that those all need to be closed immediately. 411 00:55:04.520 --> 00:55:05.240 Sara Zabih: Thank you. 412 00:55:10.400 --> 00:55:14.060 Naana Cleland: Well, we probably need to reiterate, if it's okay. 413 00:55:15.830 --> 00:55:17.500 Naana Cleland: Yes. Yeah, so… 414 00:55:17.760 --> 00:55:37.639 Naana Cleland: I could bring that up. So, basically, if you have any, investigational, reports that are pending, or any, APs in terms of audits, open APs for the audits, we appreciate that you close these off, before the end of this month. 415 00:55:37.640 --> 00:55:44.140 Naana Cleland: So that we can have a smooth transition from NICHD oversight to the lab center. Thank you. 416 00:55:51.840 --> 00:55:53.970 Kathie Ferbas: Are there any other questions? 417 00:55:59.650 --> 00:56:02.289 Grace Aldrovandi: Don't you want to hear Vanessa's voice again? 418 00:56:03.690 --> 00:56:06.020 Vanessa Pinheiro: No. 419 00:56:09.840 --> 00:56:11.960 Grace Aldrovandi: So again, this is recorded. 420 00:56:12.200 --> 00:56:16.269 Grace Aldrovandi: And we're gonna be putting the recording somewhere. 421 00:56:17.700 --> 00:56:21.289 Kathie Ferbas: The recording will be on the… on our website. We will upload it 422 00:56:21.500 --> 00:56:38.420 Kathie Ferbas: quickly, without translation, and then we will ask, Frontier to work on getting a translation added to it, and a transcript. But, well, actually, ask them to get a transcript added to it that you can use to translate. But it will go up without a transcript, relatively quickly. 423 00:56:39.030 --> 00:56:45.760 Grace Aldrovandi: But you can always download the transcript in English and put it through Google Translate, right? It won't be… 424 00:56:45.760 --> 00:56:54.420 Kathie Ferbas: Once we get… once we get the trans… once we get the transcript. It takes them a minute to do that. We'll upload it without the transcript first, and then we'll replace it once the transcript is available. 425 00:56:57.510 --> 00:57:16.539 Grace Aldrovandi: So, start working, you know, on your fun times to play with the website, and if there's anything that's not clear, or that you think we could… would make it more helpful, we are really committed to quality improvement. So, really look forward to your feedback on 426 00:57:16.610 --> 00:57:23.320 Grace Aldrovandi: what is good, what isn't so good. And, we'll work on making it better. 427 00:57:31.350 --> 00:57:32.190 Kathie Ferbas: All right. 428 00:57:32.330 --> 00:57:34.849 Kathie Ferbas: Well, thank you, everybody. 429 00:57:34.970 --> 00:57:42.490 Kathie Ferbas: please, again, reach out with any questions. The email address is… I put it in the chat a couple times. 430 00:57:42.640 --> 00:57:49.740 Kathie Ferbas: And you can always reach out to anybody that you know at the lab center if you can't remember what the general email address is. 431 00:57:49.950 --> 00:57:51.229 Kathie Ferbas: We're all here to help. 432 00:57:51.470 --> 00:57:52.020 Grace Aldrovandi: Yeah. 433 00:57:56.300 --> 00:57:57.020 Kathie Ferbas: Alright. 434 00:57:57.600 --> 00:57:58.430 Kathie Ferbas: Thanks, everyone. 435 00:57:58.430 --> 00:57:59.260 Grace Aldrovandi: Thank you. 436 00:57:59.440 --> 00:58:00.250 Naana Cleland: Bye. 437 00:58:00.250 --> 00:58:01.930 Kathie Ferbas: I'm welcome!