[NOISE] Now we're going to take the thinking that we've already done about the morphine marinol study. We're going to think about planning a strategy for setting up an Electronic Data Capture system. Specifically, we'll think through some exercises here, related to the data collection fields and the instruments that we're going to need. And then we'll move forward into the Electronic Data Capture system itself and then do the exercises. First a few assumptions. First, we're going to make, make the assumption that it's okay if we don't get it exactly like the manuscript. I took some liberties in setting up this particular exercise. some of which were to simplify things, some of which might have been a better idea in the first place had we thought about them. Second, even though we're going to assume that we're going to collect the data directly at the bedside from our patients' cohort, we're, we're going to assume that we're going to do the Visual Analogue Scale on paper. we're going to make that available to the patients, we're going to have them make their marks on the lines, and then we're going to have a research coordinator measure those off with a ruler. Input that number into the Electronic Data Capture system. Third, we're going to assume that we're going to use external processes and workflows to facilitate drug randomization and thermal stimuli schedules for each patient. This could be done at the time of subject enrollment. a good study design, a good statistician group working with us. They can easily set this up so that as each individual is enrolled in this study, we'd have the full course of the drug combinations there that will be given in each visit along with the the thermos stimuli ordering at each visit. We'll assume that we're not going to worry about that in this exercise. I'm going to stick to mainly the data collection and management. But but that it would be available to us. Okay, so, so really with this particular study, we've got a baseline or a screening visit. And then we've got several visits after that where we're going to be doing the thermal stimuli and measurements. So we're going to think about the data capture fields in, in really, really two parts. The things that will be done at the first visit, and the things that will be done each time at every other visit. The first thing that we'll need to look at is a Person Identifier. We'll, we'll identify for the study, each person with a unique identifier. That will more than likely be simply a a dummy ID that we'll create for that individual for reference in this study, rather than something that would be currently identified to, to that individual. As we mentioned earlier, we'll collect First Name and Last Name at separate discrete fields. We'll collect Gender, Hair Color, Dominant Hand, all as coded variables and using the coding choices that we discussed in earlier video. We'll record Height and Weight as numbers. We'll, we'll collect those in kilograms and centimeters. And in so doing, we'll set a range check in the Electronic Data Capture system. So, so that know we're in those ranges and, and, the individual putting in the measurements is not confused about units. We will collect both, Weight and Height only once, we'll do that at the schedule scheduled baseline visits. And, and the reason we'll just do it once is that you know we'll assume that we make make an assessment we realize that any changes in weight sort of height over a short visit schedule, like the study here, really wouldn't do much to impact the study outcome measurements. And, and we would would sort of err on the side of only collecting those once rather than collecting them multiple times and, and going through that that, that exercise and that sort of study expense, if you will each time. So we'll collect those only once. Smoking status, we'll collect as a coded variable. Each time we collect the coded variable yes and no, we'll collect it the same way, 1 being yes and 0 being no. We'll collect Date of Birth as a date of course, we'll we'll collect it and format year, month, date. Pregnancy is another yes no question, we will ask it, coded the same way as we just described. But we'll only ask that, that question if the subject is known to be female from the previous gender question. We'll collect whether the, the individual is a current drug user. Remember that if they answered yes here that we would exclude the person from the study, that is what's in the exclusion criteria. We'll, we'll collect Ethnicity and Race as coded variables as you see here. We'll, we'll collect the Consent Forms. So this one we didn't talk about earlier but Given the fact that the patient is going to be through, going through a Consent Form might be a good idea, once the signature layer is there, to go ahead and scan that in and upload that as a file in the Electronic Data Capture system. Finally we talked a little bit anxiety. We'll, we'll say that for this exercise we'll, we'll play around with the concept that. We, we've gone through the literature and we're not really sure the anxiety is going to play a factor as a confounding factor in our study but, but just for just for the sake of this exercise. We'll set it. We're going to use a, well established validated instrument. From, from the PROMIS collection we'll use the PROMIS Short Form - Anxiety and we'll collect those measurements. And, and talk about them a little bit more as we go into the EDC system itself. Finally, we'll assume that even though we talked about the athleticism and fitness earlier as possible confounding factors. We'll assume that we went through the, the proper due diligence and we decided at the end of the day that they really weren't worth including as measurements in this particular study. Now that we have our baseline visit data elements to find, let's move on to the visit data. This is each one of the visits where they're going to have a drug and then go through the pain measurement protocol. First we'll record the Person Identifier. Again, this will be the same as we described in the previous slide. but note that the visit data should not exist for a subject if the demographics or the baseline data is absent. So our system should take care of not, not allowing us to have orphan visit data information. And only allow us to enter information where, Person Identifiers that had been previously defined in that baseline visit, screened. We'll, we'll record the Date of Visit each time in the same format as before, we'll record the Drug Combination. And again, this is all going to be pretty, pretty defined at the beginning of the study for an individual patient or an individual volunteer. But that, just for a sanity check, each time as that drug combination comes back from the pharmacy, we'll ask them to report, also, the, the, the integer between 1 through 24 that they are working that, that they use in preparing that cocktail for each individual visit. So that'll just be, should be the same each visit. But we'll record it just in case. The Thermal Combination, again, this, the, the next several measurements we'll do for each Thermal Combination. And we'll assume, again, that we're going to get that Thermal Combination, measurement schedule in a, in an envelope at the beginning of the study, visit and the, the nurse would just open that up, in the, in the, she would take them through the protocol. Thermal Combination 1, we'll record that as an integer. what, you know, what, what, what what sequence that's going to be for those three measurements. and with those three thermal measurements or, three, three thermal stimuli that are applied, we'll take sensory pain measurements and that would be on, on a Visual Analog Scale. the subjects will make a mark between 0 and 10 centimeters on the line. The left hand of that line will be labeled with no sensation, the right hand of that label might be marked with the most intense sensation imaginable. And the subject will be given the instructions to please mark on the lines to indicate the relevant intensity of your pain sensation. after Thermal Combination 2, they will be asked to do the same thing. only this time they will be asked to describe the unpleasantness of the same, of the pain sensation. We'll do that with Thermal Combination 3. And 4, same type of measurements as above. And at the end of the study period, study visit, we'll ask for information about adverse events. Specifically we'll ask them yes no questions about whether there is any redness or swelling observed. We'll we'll have the research coordinator ask if they have any sort of disorientation. And then finally, we'll ask in a yes no field and then finally we'll ask the, the volunteer if they had any physical or mental sensations. Other that those related to the heat probe testing that, that they experienced after get, after receiving the drugs. That'll be a yes no question and if, if and only if the question is answered yes, then they will be able then, be asked to describe and we'll record that in a free text field that, that experience. Okay, so that basically sets up the study field definitions for this particular exercise. We'll now go into logging into an Electronic Data Capture system. We'll use we could use any. But for this particular course we'll be using REDCap. We'll show you how to log into that and then we'll go in and create this particular study using that EDC system.
