Okay, so once we're confident that we're getting good quality data and once we've covered the basics concepts of planning the data collection forms and the, the entry components. Probably the next best thing to think about with the, with any electronic data capture system would be able to, to look at the viability of getting good quality data out. So in REDCap we have, here a screen that shows really a couple of screens, that the, the one at the, at the top there really kind of shows how an individual with rights to this particular module in REDCap Would be able to sort of select fields that are associated with individual forms or even individual field elements within forms, to, to export. Once they click the export piece they they will be handed a data set that That, that really is formatted for use in any of the common statistics packages. The pink section that you're seeing there in the in the larger screen shows, shows how we've embedded as well some de-identification tools that allow date shifting to occur and identifier information that known identifiers to be obfuscated as we shift it. And some investigative teams use that, sometimes that's very crucial to a study, sometimes they don't, but it's, it's there in case they need it. another thing that you'll see in the bottom screen there is that once you've, generated those files, you could either download them and use them on your, secure, sys, system for, for analysis now. Or there are some secure mechanisms for transferring files among team members, u,using, u, using really, data transfer capacity, or we call it SendIt in REDCap. And this allows you to, generate information, send, send along files, either the ones that have been generated using the statistics, Export that I just, just showed, or, you know, maybe, maybe files that are uploaded just for the, just for the purpose of transferring securely. It allows you basically to upload files and be able to send those in a secure way to, to partners whether they're in REDCap or not. Audit trails are very important and while these, these are not terribly exciting to the research teams from, from the perspective of the day to day operations, they sometimes come in very handy. If, if there's a need to go back and look at who did what to the data at any given time and, and we know from other, earlier modules and sections That this is extremely important, for, for a good clinical practice and for HIPAA and for all sorts of reasons. Mainly it's a good idea because if you care enough about the data to collect it, you really should be keeping good solid audit trails of, of who's doing what to the data at any given time. There're some, some logging features within REDCap that are not, easily viewable by the end user that That have more information even about who viewed what data at any given time. But , but for sure. We like, including a module in any study, that, that research teams are using. So that they have the, the ability to go back, and, and review those audit trails in various ways. This is extremely valuable for submitting, studies to human subjects. review board, or the IRB, if you're in the US. it's important to put in this, this sort of detail and grants and contracts so that really the, the tea, teams reviewing those know that you're doing the right thing in terms of treating data securely and, and in a fashion that's, that's associated with good clinical practice. Another thing that's, that's important in any electronic data capture system is the notion of rights in REDcap. Any individual can be added to a studey. After they've been added to a study, we see on the right there that They may be, the project owner has access and can associate a particular user at the form level, they can have read write or no access to specific case report forms, or survey instruments, and they also have the ability to dial up or down the, the access to particular modules, that, that, that get included with any REDCap study. This is really critical. Because we, we set it up. we set up REDCap, at least, to be very very autonomous. And, part of that is being able to put in the hands of research teams the ability to, create and, and review, and iterate on their case report forms. And get the data just right. We also want to make sure that we have the, in the hands of the same project owners the ability to add and remove users as needed without intervention from a programing team. So again I keep speaking about REDCap here, but this is a function in capacity that really should be should be considered when selecting any electronic data capture system. setup should be fairly intuitive and fairly easy. And REDCap, we we have set things up so that there's a lot of point and click action that can be done by non programmers. And really there's the option of instantiating a new project in about 30 seconds. We just ask for, for very rudimentary. set of data about the particular study, they can instruct from scratch as you've seen here with the option in the middle to create everything myself. Or you know, individuals can start from template, that template might be of randomized clinical trial with randomization built in, or you know, might be a mouse colony project. So, so having. The system to be able to sort of quickly launch the planning team or the research team in our case is, is very critical and, and something that we've seen over and over again. helps because it really puts the power back in the hands of the researchers rather than programmers. Again in, in the RedCap system, that, that instantiation of a project goes very quickly. There are tools, there are point-and-click tools that we'll see a little bit later that that allow real time case report form and survey creation by the end users. In some cases, there is a need to if we're doing a longitudinal study, maybe there might be a set-up of Of, of, of study events events that could then be used in a scheduling module when, when you're scheduling outpatients. So you know, just easy point and click non-programmer use of the tools is, is again sort of one of those things that, that should be should, should be consideration for EDC projects. And REDCap, went up. we love the point and click work if we're donig small to medium sized studies. You know, 30 40 questions. It gets a little bit cumbersome if you're doing 4000 questions, for, for a study for a longitudinal period of time. And so one of the ways that we've kind of, kind of designed around that is the ability to have a. Data dictionary that, that can be created. IT has all of the elements of the data that you're going to be collecting which forms whether it's a select box or a type in box etcetera. Have that all, represented in a table based program like excel. And so that you can import. Export, and be able to sort of manage the metadata, or the data coding at the file level, rather than doing all the point and click work. This is also very convenient for studies where you want to share with colleagues. I've got another group that's using REDCap at another institution. They would love to be able to reuse some of the work that you're doing, and not have to reinvent the wheel. And by the way, that really might help us to share data later on if we go that route, so it's very easy in this file based methodology to transfer the data dictionary, or the metadata for the study around from site to site, an, and thereby, get, get up to speed very very quickly in, in a new study. we've mentioned in earlier sections that, one of the things that's very important is, an, in planning data collection and strategy is sort of the reuse of validated instruments whenever you can, we also showed in an earlier section, library that, is available for, For, for use by, by REDCap users to make it easier than, than coding all of those validated instruments into the electronic data capture itself. Here's another shot of that library front screen, and it, it goes through the validation considerations, the licensing agreements, etc. And if are coming from REDCap there is a function that will allow it to automatically shoot the, the meta-data for this particular instrument into your study capture protocol. So, so that's it's there just as if you'd gone through either the point and click method of creating a case report form or survey. Or the file based method that we talked about in the last slide. So in any electronic data capture system, one of the things that you want to look for is ease of use, because you really want to reduce the training costs associated with your staff, and if you're doing multi-center studies, maybe there's a coordinating center. You certainly want to reduce the staff, staff training time at places that are remote from you. So what we do in our system, again, we really, put a lot of stock in putting the power in the research teams that are conducting the studies. We try to, to be very liberal about including in-line video documentation within the platform. We found that the people will typically watch a two-minute video where they will not take the time to download a, you know, two-page Word document or a PDF document with, with a manual of instructions, so we've found a lot of bang for the buck for including those and embedding those videos. Just in time. Just at the point where you might be wondering, hey here's something around what you are doing right now that, that should take 30 to 45 seconds to watch. People will watch those, and there'll be less questions downstream. So we found that in addition to being able to upload files at the personal level, if we're doing a human study. In a case report form. Maybe that use case would be well I'm looking at this individual's demographics, I have his signed consent form in a PDF and so I want to upload that data and associate it with a particular case report form. That's all doable. We've found as well that it's important to think about study-level files, and so in REDCap, we have a module called the project file repository where end users can upload study documents, not necessarily associated with an individual person, but, but associated with the entire study, maybe an overall consent form. in the, in the middle section there we see data export files and that's where individuals can go in and find sort of a static copy of data any time that its been exported. We go ahead and park a version of that sort of snap shot of that data. in, in the form of an export files in, in this repository as well. So it's very good for projects, specific files, it's very good for for frozen data sets and you know, we found that smart people use generic tools in all kinds of ways and people tend to find a way to to leverage this for good use.
