So yeah, I'm here to talk about the human subjects clinical trial forms as you respond to the I ri RFA in a month. If you're doing human subjects research, you will have to complete these forms at this point. And so we thought it would be helpful to take you through the forms. As you know, there are two project mechanisms, research and pilot project mechanisms, you completed the LOI phase. The full proposal is due October 21. So you would have to have these forms be ready before that, and you will submit everything your full application and these forms through this website. If it is hard to If there aren't enough tabs to submit, you can feel free to e mail me and I will forward it to the reviewers as needed, because I'm also the scientific review officer for this process. So I identify the reviewers and send them the materials so I can make sure that your clinical trial forms reach the reviewer. You can follow the same formatting requirements. So, however, you have formatted your primary application, your research strategy section, you can use those same fonts for your clinical trial forms as well. So I will take you through the form itself and then we'll come back to this PowerPoint. So just to show you the different forms, the first form that you will have access to on our website is called the human subjects and clinical trial information form. And the first question that is asked is whether you are conducting research with human subjects. And if the answer is yes, then you move forward and complete all this paperwork. If your project is exempt, Then you do not need to complete this paperwork, the criteria for exemption are these federal criteria. There are eight different criteria. One of them for me is sometimes is number four, which is it's a dataset analysis. It does not involve contact with human subjects. It involves de identified data. And third, there is no reason to receive consent from our participants. In those cases, your research is exempt, and there are eight different criteria for when that could happen. Um, if you fall under these eight criteria, you would consider your research Exam. You do not need to complete these forms. But if the answer is yes and no, you will need to complete these forms. And at that point, you click on this record to extract study record. And so you get a new form called the study record form. You just download it to your laptop, and then open the form and here, And that is where all the information is that you need to fill out. And there are a lot of uploads within this form. Your inclusion of women and minorities, inclusion of individuals across the lifespan, and so on. There are several forms that you upload into the study records. So this is a pF that has its own attachments, and then you take that completed PDF and add or upload into the primary clinical trials form. So once you complete your study record form, you will then upload that study record form into this human subjects clinical trial form. So it's a lot of forms uploaded into a single study record form, which is then again uploaded into this human subjects clinical trial form. So it is made to be a little convoluted that way. So be sure to do these steps. Delayed onset studies. These are studies that are a combination of, let's say a data set study and a human subject study or a basic science study done on cells and cellular bench workork, and then you shift to doing a human subject study. In that case, you call your study a delayed onset study. You don't need to submit a lot of information right now, but you will do so later. And so you add an attachment explaining why yours is a delayed onset study. In that case, Yeah, you're not filling out all this information at this point. You're just justifying that, you know, you might need to do this later. Right? Then now let's go into the study record form, which is where all the information is. And so at this point, I will shift to showing you my study record form from a previous study so you can see what information is to be uploaded at each point. And every so often, I will stop and ask you questions so that you have clarity on what I'm saying. I also have this exempt determination form. Usually you have such a form from the University IRB or the institutional IRB at your institution. So you should refer to that, but it should be similar across institution. This allows you to understand which studies are considered exempt and whether your study falls within the exempt categories or not. And I'm happy to e mail this to you, but this is very specific to University of Delore. So before I move into the study record form, are there any questions related to the primary form, the human subjects clinical trial form? Anything? Please because I cannot see you, feel free to just jump in and ask a question. Okay. So it looks like we have clarity on this part. I just took you through the human subjects clinical trial form up to here. And now we are moving into the study record form, which is extracted by clicking this button, and then we upload information into that. Okay. So what does the study record form ask? The study record form first ask similar questions to what we just saw. So Study title. And then it will ask you whether your protocol is exempt or not. And so if it is not exempt, then these questions need to be answered. So just to make it a little clear as to what they are asking, they're asking if you have human subjects involved, if you're conducting an intervention study, if you're assigning prospectively a participant to one group or another, and intervention here is defined very broadly, which means if you're even studying a person in one condition for a 30 seconds versus another condition. That could be considered an intervention, and so that you will need to complete these forms. So it can be a single session evaluation where multiple conditions are being offered, and one is a control and the other is the treatment. And in that case, you would have to fill these forms. Is the study designed to evaluate effect. So are you comparing outcomes between these two treatments, no treatment and treatment, even though it's a very brief treatment. Is the effect that will be evaluated a behavioral or biomedical outcome? As long as these are yes, you need to provide further information. Otherwise, you know, the answer, if the answers to all four questions are yes, then your study meets the definition of a clinical trial. If the answers are no, then at this point, you do not have to move forward and fill out a lot of paperwork. That is something to remember. Next section of the study record form is looking at the studies characteristics. So who are the groups in your study? What are their eligibility criteria and age ranges, as well as various form files. So there's a file on lifespan in. So what is the age range of the participants in your study? You upload that at this level. Then there is a file on women and minorities. And so you talk about whether women are participants in your study. So I study children. So I usually say that, you know, male and female children may participate in this study, and parents of children may complete surveys for their child, but the data are not based on the parents themselves. So we clarify exactly how the women are participating in our study, as well as minorities, what effort will we make to recruit minorities. And how is our proportion or demographics in the study based what is it based on? So for me, I study autism. So a lot of our children are adults. So, sorry, our males. So 80% of them tend to be males. Then what effort are we going to make to recruit female artistic participants, as well as a diverse pool of artistic participants. We talk about the demographics in which we conduct our study. The geographic location in which we conduct our study, what are the demographics, as well as what efforts will we made to reach out to minorities? All of that is provided to you in these forms as an exemplars. If you look at the study record form upload. So in the ZIP five on the NR website is the clinical trial forms Exemplar ZIP five. So if you download that, you will be able to find these forms, and this is just an example that I will show you. It's not very long. None of these forms are very long. You know, one or two pages, maximum. The human subjects form is pretty long, I think because you're describing your whole protocol there. But you're, you know, describing the demographics of your sample and that what you expect to see from your recruitment areas and that how you make efforts to recruit minorities in your sample. So this is that. And then recruitment and retention plans. Here you're talking about, so this is the 2.5 upload in the clinical trial form. U The recruitment and retention plan specifically talks about the methods by which you recruit as well as the methods by which you retain your participants. So we had a multi site study, so we had to explain the recruitment sites at each of the sites, how we were going to recruit our participants. And then also the timeline, that how were we planning to recruit you know, so many at UD, so many at the University of Connecticut, and how we were planning to retain these participants. So, you know, we make sure to be flexible about scheduling our visits with our participants. We make sure to provide them data about our evaluations, we send reminders about the date when their testing is going to happen or training is going to happen. We are flexible about ing things remotely and things like that. In general, we are providing a service, right? We are providing an intervention. So we see a lot of enrollment, and we do not see as many dropouts in our studies because of the fact that this is a study that's providing a service. But there could be other explanations that you could provide to explain how you'll retain your participants, perhaps participant incentives, as well as other motivators for continuing in this style. Recruitment status. So that I have expanded here. Typically at this stage, either you might have already started this study because you're doing an ongoing study or you might not yet be recruiting because you're waiting for funding to arrive. Accordingly, you make these choices for recruitment status. Then study timeline talks about how you plan to conduct your study. This is another example of how you should put study timeline data for every project in your grants. I put this in my grant application as well as here because this now requires a study timeline with a lot of detail, but I provide a more abbreviated version of this in my research strategy. At the very end, I always explained my study timelines. This was a On application so five years, four quarters. We call this a gain chart. You can make this very easily in Excel. Um, and so we started all the way from IRB approval down to dissemination and how we were planning to recruit participants. And we explain all that in bullets underneath. And so, yeah, this is an example that you can follow. I'm sure there are other ways to provide this information. Next is enrollment date. So by when you anticipate recruiting your first participant. F s it was, you know, so we took generally, the way you do this is you should anticipate when the funding will arrive. So for us, that is around mid May. So you could put a date of June 1 as the first participant that will be part of your DM study. That's the date Or if you expect to get IRB approval? No, this IRB approval will always be there. For a deware in study, IRB approval should be in place by March 3. For that reason, you could say June 1 or July 1, however you want to do this because if there is some sort of preparatory stage, before the data collection starts, then you want to account for that. Before I move on, are there any questions around study or group characteristics? I stop. I've answered questions if there are any I joined a little bit later because I had another commitment. Will you be posting sorry The recording. Thank you. Appreciate. Yes. The recording and the PowerPoint, I will post it on the Delaware I website der Thank you. Okay. So moving on, let's talk about the inclusion enrollment report. That is part of this PDF. So if you look at the PDF, as you're going through it, you'll see that the inclusion enrollment report is right below these questions. So there's the study characteristic section where you put the study title, you put the different groups and explain your groups, your eligibility criteria for your participants inclusion exclusion criteria, your PDFs on inclusion as well as recruitment retention, study timeline, all of that, and then comes the inclusion enrollment. So you're describing where you're recruiting, from, and then you're describing how many participants based on the demographics of your sample. You will know that you are estimating that based on past studies, as well as what happens within the state of Delaware in general, and within the areas where you'll be doing this study for males, females, Hispanics, not Hispanics, as well as the other specific races. And so whatever sample you're proposing, you distribute it between these various categories. And this is an anticipated number. You're not you know, bound to do this, but you're trying your best to get to these numbers to include minorities. The cumulative one you leave empty. Cumulative is really for people who are being funded and are reporting based on a progress report, also, or for some reason, if you've done the study for many years and now this is adding on to that, perhaps this could be used, but usually we don't use this. Next step is protection and monitoring plans, which is the more detailed document, how you describe the protection of your human subjects, what you state within the multisite study single IRV plan and Data safety monitoring plan, and then the structure of the study team. So let's go through that. Okay. So So protection of human subjects. So this is very much along the lines of your IRB protocol, and I can show you the sample I have provided. It looks like this. So you really start off with your study participants. You explain what the age range, how many participants where you will be recruiting from, your recruitment methods, your screening process. Again, this is written in the format of a clinical trial. You know, the process for your research might be a little different. So you will align the writing based on your study design. This is mainly inclusion criteria, exclusion criteria, matching criteria because we are prospectively assigning participants to different groups. So we have to explain all this ahead of time, how we randomize participants across group across the two groups. And then your study procedures. What are the screening measures, what are the assessments, outcome measures, who is conducting these assessments? Are they qualified to conduct these assessments? Are these assessments valid measures? You know, how long does it take to do these assessments? These are the types of details you provide in your IRV protocol anyways. And so those details go here as well. There is no page limit to any of these documents. So you can take all the time you need to explain the details here. But not to treat this as an alternative, not to use these sections within your research strategy and say that, h, if you want more details referred to this section. Whatever is in the research strategy should be sufficient to explain the project as needed. Usually, I refrain from referring to this section as, Oh, if you don't have more details from my strategy, refer to this. NIH doesn't like that, that this is being used as an alternative space to put details. Everything required should be explained in the research strategy. U Then the intervention protocol, how many weeks, how many days per week, how many minutes per session. All of those details, what the intervention involves, who the people are that are providing the intervention. You know, what are your fidelity measures? What are your measures to assess feasibility? If this is an early phase study, what are the exact interventions? What are the risks of your research? You know, you expect to test somebody for an hour, hour and a half that could lead to u um, the child getting tired or the parents feeling burdened about coming to the lab to do the testing. All of those should be honestly reported here. And then how are you going to make sure to protect your participants against these risks that, you know, there are people involved who will guide the child to make sure they don't fall or make sure they are safe. There will be a process of consent where all the information will be explained to the family before they agree to do this study, you know, the parent will be nearby. He'll be able to see the child as needed. T. I'm going to think of what other things? Assents are needed for children who are above seven years? And so we make sure to have those forms available and in our case, we have to have a verbal or a reader ascent, then a non verbal ascent, which only involves pictures and all of that. So written as well as picture based assents need to be included in our case. Other details, what do we do to make sure our data is valid and protected. So how do we protect our data once we collect them, as well as how do we ensure that the information is valid. Who is checking these data? How often are we checking these data? How are we de identifying the data and how are we storing our data? All of that needs to be described in detail. We were doing a two side study. And so we had to come up with what's called a single IRV plan, which is the approval would be done at UD, and the same procedures would be followed at both sides and that the other site releases its, oversight of the study and allows UD to provide the full oversight? That takes some time to work across two institutions. If that is happening, make sure to plan for all that extra time to get that single IRB set up. These involve vulnerable subjects, then you want to be clear about that and that why is this research important? What is to be gained from doing this research? That all goes in the human subject section. Are there any questions about the human subjects document? Sure. Bye, Julian. Any questions about the human subject section? I will keep going. And as questions arise, please let me know. Share screen. Okay. So we've gone through the protection of human subjects, a single IRB plan. It's basically saying, you know, it's just few lines saying that the IRB of record will be, in my case, it was UD, and that UK will release their oversight of this study. And all procedures at both sides will be based on what submitted to UD. Data safety and monitoring plan and data safety and monitoring board? Both of those go together in one document. And essentially, you're talking about how do you maintain validity of your data and think about those things ahead of time. So in this case, who is the PI? Who is the CI? Who are the people overseeing specific aspects of the study? Who are the people conducting the study? And how is the PI or CI going to maintain oversight of the word? What are some of the things we will regularly check. And make sure that the data are being collected properly stored properly in a secure way, as well as making sure reliability is ensured for the measures that are being administered, so if there are any processes for assessing reliability, I would describe that here. Also, how we ensure safety of the data, how do we keep it secure? How do we keep things de identified and confidential? How do we ensure reporting of adverse events? If there are any adverse events, do we have a plan in place or how we will be reporting them? And do we have a data safety monitoring board? So DSMB is required after a certain phase of the clinical trial. So if your clinical trial phases three or four, Then perhaps a DSMB is required. But for one and two, you may not need a whole board of people overseeing your study, but you might need a independent medical monitor. So for me, it was a faculty in our department who had experience doing clinical trials. They were the overseer as such, not a whole board of people where they would help assess whether the study can continue to go on should there be an adverse event or a major modification to the protocol. And then we will take her advice to determine whether to continue the study or we need to report this to the funder or the IRV as approve. That's what the monitoring plan is, you know, ensuring the validity of your data and the safety and security of your data. And, in this case, we said we don't need a DSMB overall structure of the study team. So you know, for this study, it's pretty small. The structure is not as he right because it'll be a one or two years study. Are you able to see my screen? Is that something you're able to see here? Structure of the study team. A able to see this word document. Have I shared Soy can go. We can see it. I can see it. Yeah. Structure of study team and the boxes. Okay. Perfect. Thank you. So yeah, here, you're basically describing the people involved in the study, who the key personnel are, who the PIs and WIs are? You may not need a visual. If it's like a PI and a student, you don't need to provide a visual, but you're describing the role of the people involved in the study. Who is providing oversight, who is actually executing the testing and training and evaluations, who's doing the screening and recruitment? You know, what are the different sites at which you're recruiting? How are they helping you to talk about that? The single IRB, how it is going to be administered. You know, what are the processes involved there? Maybe briefly, that can be who is responsible for administering those processes. That could be described, you know, your lab manager, who's helping you back up all the data and keep it secure. Who are your statisticians, perhaps, your consultants for your project, who are your collaborators in the project? All of those details can be included here. And again, no limits to how much you write about that. You can explain their expertise if you'd like to, you know, along with their names, as well as their roles. Yeah. Then you're on to the last section, which is the pro protocol synapsis. Protocols sys is synopsis is really just telling people about how the design of the study is. There are two groups and then there's a screening and a pre test and a training and a post test phase. There's also follow up testing. What are some of the interventions that can you see my screen? I can see my screen. What are the interventions that you'll be providing? You know, the control group as well as the treatment group? What are what is the phase of your trial? So there are four phases to any clinical trial based study. This was phase two. We had done some of the preliminary work and we were trying to expand it to a larger study. Three would be where you're now starting to study effectiveness in multiple different subgroups and also looking for side effects and things. And four is a community implementation and a much larger scale study, where now you're just monitoring the outcomes for over a longer period of time. And so If it is Phase three, a lot more needs to be done, this was not. This was just a phase two. What type of model are you following? This was a randomized control trial? Are you doing masking? Are you allocating and how are you allocating randomized or non randomized? In our case, the allocation was randomized? Then you have outcome measures. List you can keep adding outcome measures. You list all your outcome measures, how long they take, how many times they're administered, what exactly is involved in that test, how valid is the test. All of that goes in here. I know that you describe it adequately in your research strategy, but you have to provide it here as well. You can put more details if you like, but this is not considered a substitute for what you provide in the strategy. Section. So that's this here. And then at the very end, you provide information on statistical design and power. You provide information on the duration of the study and whether this is an FDA regulator intervention. You can also provide a dissemination plan. And if there is an additional extra form you need to add. You can use these add attachments. I usually attach the resource sharing plan here. That is how you're going to share your data with others, but now we have a whole another system for that, you know, the DMSP, the data management and sharing plan document, which is uploaded separately. So you don't have to put that here. Just upload that separately. And we don't need that at this phase. We ask for that form at the just in time phase. So if you're funded, then we ask for the data management safety plan. So sharing plan. So you don't have to upload anything here. So I can take you through the statistical design and dissemination plan really quick. This is not needed right now. The statistical design and power document is essentially talking about the methods you use. So it is similar to the statistical analysis section of your actual research strategy, but, you can take more time to describe the details of how the two groups will be compared on which measures, how post analysis will be done, any kind of corrections that you will do. You can explain that. If you have sample size estimates, you can report that here. Those are considered important, especially for any kind of intervention study. And if you have information from the literature on how effect sizes are to be what the effect sizes are, you can report that here because literature suggests so and so. That's what this is. All right. Dissemination plan, what is your plan in terms of publications? This was a five year study, yours is just one year or two years. So, you know, obviously, the expectations are not this. This is just an example. And early on, you know, you take the time to do the study, so it takes you the time to publish thereafter. So considering that, you would write appropriately. This is just an example of how you can explain your dissemination on Uh, for through conferences, papers, any kind of local presentations. You will do all of that you can explain in this document. And especially when you have multiple teams involved, how are the authorship guidelines going to be followed? Who is, you know, the first author versus last author, and how is the work going to be divided across teams, that needs to be fleshed out here. But perhaps that is not an issue for a smaller project because it's a single PI study. About studies that conduct human subjects research, but are not a clinical trial. So for example, an observational study, which belongs to group two. Group one, if you remember, were exempt studies. They do not require a clinical trials form to be completed. Group three would be forms that are related to clinical trials themselves. So the entire form has to be completed. This is the case where all four questions in the study record form are a yes. But anything in between that involves human subjects, but is not a clinical trial, also requires portions of the clinical trial form to be filled out. Those are the sections one and two. Sections one and two need to be completed within the study record. And then Section 3.1 should be completed. This is the protection of human subjects or the human subject section should be uploaded. The study record is still uploaded into the larger human subjects form, and then submitted to us.
Clinical Trials Forms Webinar DE-INBRE Pilot and Research Project 2024
From Lydia Schlitzkus September 30, 2024
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Dr. Anjana Bhat reviews the clinical trials form process for the DE-INBRE Pilot and Research Project Proposals-2024
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