So in this segment we'll be talking about standardizing processes for clinical and translational research studies. In previous videos we've talked about the importance when planning a good data collection strategy. Of writing standard operating procedures, having those available for, for all of the staff, having them available for documentation. And for referral back to methods that were used in this study. But we left it at a very high level. In this particular segment, we're going to go a little bit deeper. And we're going to dig down into a little bit of detail on the the, the best principles in terms of thinking about standard operating procedures. what they are, how, how to sort of think about putting those together. different topic areas that that might be of interest for you when you're, when you're creating a standard set of standardized operating procedures or SOPs. And then a little bit more on where to go for, for more information. You'll find that this is a topic where there's a lot of information, there's a lot of documentation out there on the web that you can use. We're not going to to go into it at the at the, the five foot level at this course because we are doing data management. Here but we will sort of cover it a little bit deeper than before because there's some things that, that at least data managers and people working on data management plans need to be cognizant of. And over all or a global sense as they're planning out studies. So before I get into the content I want to give thanks and acknowledgement to a, to a great colleague of mine Bree Burks. My, my team, we do a lot of data coordinating center work. We do, we of course, follow SOPs and standards in managing data but Bree supervises actual clinical operations in units here at the Vanderbilt Hospital. And so I went to her for advice on, you know, best practices in terms of creating global plans for for, for creating SOPs and the documentation that we will be covering in this segment. She couldn't be with us for this video shoot but many of the ideas and much of the material comes directly from her. So, the first thing that's important is defining your project. So, what is the main priority for your project? What outcomes are you trying to achieve? So even before we start the SOP Good creation and, and thought process, making sure that we're defining the scope. And, and looking correctly at the, at the different elements and parameters of the study itself. And again, we've talked a lot about that from the data management standpoint but here we're talking about it mainly from the. From the overall study. May, maybe what the the PI and the, and the study coordinators mi, might be looking at. So making sure that you are cognizant of the main priority of the projects and, and you're really looking hard at the outcomes that you're trying to achieve. sort of along those lines, what are the, what are the general Short and long term goals for this study, particularly, are they measurable, who are the key study personal that are involved in the project? What are their strengths, what are their weaknesses? How are you going to align things so that they're doing, playing to those strengths and designing away from those weaknesses. What are the priorities for each person involved? What are the short-term tasks that they will be managing? what are the project metrics that matter? It's kind of, kind of relates back to that first bullet point but again making sure that even from a not may be the study endpoints. But the operational metrics that will, that will tell you as a coordination team weither things are going well and on schedule. Or maybe weither, weither they're slipping a bit. So, so basically trying to come up with things up front on the project metrics side they're going to help make sure that the management of that project is, is right on track down the stream. And finally, assessing and defining realistic timelines and remaining focused on those priorities. As a part of all of that, it is really important to think way up front about creating written standards or again SOP's, standard operating procedures. Because these are going to increase your chance for success, they will enhance compliance as we've said before. They will also allow you to, to quick, to train and bring on new staff much quicker. Because, because things are already in place. They're already standardized, and they're already well documented. You won't have to sort of rely on institutional memory as you pass things off. And particularly for long studies you're going to need those to sort of look back on to make sure that as you are doing your analysis. That, that things were done appropriately or they were done as expected. as well from a compliant standpoint when people come to see whether you are doing to right thing you've got everything laid out there in the right place in the right order. And it just makes those, those types of audits or checks, checks for consistency much, much better. So, so let's talk a little bit about SOPs. SOP's are defined as detailed, written instructions to achieve uniformity of the performance of a specific function. In this comes directly from the ICH. Or the international conference of on harmonization with, with a reference there below on this slide. some, some of the procedural things to consider when thinking about creating and maintaining SOPs for a study or even for a group. Or that they're essential in defining the operations and the technical components for the study. They, they really force creating SOPs up front, really force study planners to identify the potential roadblocks. And think through every aspect of the study so that there are no surprises downstream. So, so, so you're able to proactively develop and deploy solutions before you actually run into the problems. And, and sort of related to that training training comment from, from just a slide or two ago, SOPs really hold the personnel working on the projects accountable. They provide that measuring stick. SOPs provide a level of transparency. So especially when there are compliance components when you're working on studies where you're submitting data to other agencies or, or centralized authorities. You know, having SOPs is absolutely essential. It'll be part of the contract. It will be part of the work the scope of work that you have to comply with and again it just creates this level of transparency. It enhances trust that, that you're group is working on projects where they know what they're doing. SOPs are a best practice for many different services and groups, and, and again depending on the type of work that you're doing. SOPs are often an expectation or a requirement for the study or trial. So again, with the help of my colleague Bree Burth, we kind of, kind of took, took a look at this. And sort of pulled together some SOP creation principles that, that are maybe good to think about when, when going through this process. First best principle there would be start at, start with a standardized template. So, so don't re-invent the wheel. If you can find something that, that's pretty close, or, or along the same lines in conceptual model and framework. Even the, even sort of finding a template to sort of pattern your recipe or formatting on as you create a sort of standardized template for SOPs, it's a good idea. Don't reinvent the wheel. Number two, define your workflow and we've talked a little bit about that before. But you know sort of making sure that you are thinking about all the procedural elements we are going to go into each step of the study operation. Making sure that those are designed well and designed with purpose is going to be be, making is really going to make the creation of the SOPs much better and faster. finally use a, use a broad approach and create SOPs that apply to multiple projects whenever possible. Again think about the fact that, that, your group or your, your team is probably not going to be working on one project and then retiring. But hopefully you can sort of reuse at least much of the material across many projects. And some of the SOPs that you'll create for procedures and processes in, in your laboratories or in your, your nursing units or in your data coordinating centers. That there going to be consistent and can be reused verbatim from, from study to study, so, so take a broad view of this. And don't try to get terribly specific around a single project. Don't back yourself into a compliance corner by being too specific or setting standards that, that are not realistic. It's really easy to, to create words in a Word document but, but you have to really think and, and those words look really, really good in terms of the, the. The, the, the recipe or, or, or the way things were going to be done. But don't forget that you're actually going to have to comply with these standard operating procedures once they're written and once they're out there. So, so be careful and sort of balance between, being, being very specific versus being, too, too loose. You want to sort of strike that balance. But, but definitely don't put yourself in a corner by making them too restrictive or more restrictive than you have to. SOP should be self-explanatory. Standalone documents. So again, you should be able to hand these to someone. and, and have them read them and, and they should be able to understand what's done in this particular component of the trial or study or in this laboratory procedure, etc. And and without a lot of, a lot of coaching and, and handling. So again, they make really good training training materials for the staff in addition to being something that needs to be done from a compliance stand point. finally, on this slide, it's important to think of the SOPs as fluid documents and, and they should reflect changing processes. So you know, things happen. You get different equipment or you, or, or, you, you sort of learn things along the way. And we, we'll talk about some of this in the data center operations a little bit later in the course on mid study data collection for principles and guidelines. But, but, but you, know, things happen across the studies, across teams and across labs. And so, so you need to be careful and make sure that you don't write these SOPs and just throw them in a corner. But, but make sure that you, you understand that there's sort of living documents if you will. And, and, and that will need to be updated and evolved there, there's some care and feeding of those if you want to, to have them remain relevant. And you do want them to remain relevant it takes time and much like some of the other principals that we've talked about in this course related to you now, time invested up front pays off big downstream. This is especially importnat in SOP development and maintenance. It does take time. And, and what we've found is that you underestimate or you rush those SOP, SOPs. And, and you may be able to sort of have, have the, the document that you wanted today. But really, they have no value if you're not taking the time to put, put, put into them what needs to be there. And, and sort of thinking about some of these principles and doing them right. justifying unique processes or workflow practices to an external entity requires SOPs. And again, we've talked about that before in terms of the, may, maybe providing documentation or evidence o proof as you're putting in a grant proposal. Or a contract proposal or may even working with an agency as they come and audit processes. you, you're going to need to have these SOPs and especially where you've got unique processes and workflows, we will need, you will need and you will use these SOPs. And then finally, in this principle section, the, the, the five days you're not just creating documents, you're creating processes and, and procedures that people are going to be expected to follow. And so it's important that the project manager and all staff be familiar and sign off on all applicable SOPs in their work areas. So a few sort of general topic areas where standard operating procedures might, might fall. Would be administrative domain, clinical procedures and workflows data management, of course. You know, how you're doing things on the data management side and that's particularly relevant in this course. Laboratory, pharmacy. I got these broad topics off of a a website from, from the Duke Global Health Institute and would recommend, you know, as, as, sort of, a next step. Hitting that site, you'll see some, a lot of granularity on the types of SOPs that, that fall under those broad categories. Similarly the University of California at San Francisco has an excellent site that, that details some of their SOP domain areas. A little bit different type of of framing or bookkeeping here. But you see along list of a, of types of SOPs that are, that are often used in clinical studies and trials. So we're going to, we're going to kind of, kind of stop the the, the intermediate dive I guess into SOP creating and standardizing processes here. you know, like, like so many of the topics that we are covering this could very well be and and often is I think sort of a course or a workshop topic, in, in itself. Or may be even multiple workshops and and the courses if you drill down into this specific domains where SOPs are created. But, but we'll kind of stop here at this level because this is a data management data management course in, in and of itself. hopefully this introductory material will at least give individuals a working knowledge, of sort of what goes into thinking about the SOP's that go across the whole study. There are many, many online resources for learning learning and seeing examples of, of SOPs. probably the best way to, to go about next steps would be to just do a Google search or a general web search on research SOP. And you'll find many examples, many, many organizations will put their SOPs right out there on the web for, for individuals to sort of download and, and see. And so they're, they're great, great number of resources there in terms of taking next steps. So this concludes this, this segment and, and I think we, we've least sort of done that cursory or, or working knowledge of you of SOPs. And we'll pick it up with the next segment.
