In general the Study Overview Section provides the IRB-SBS with a general understanding of the protocol including the anticipated dates of the study, study funding, purpose of the study, an explanation of what the participants will do in the study, as well as the “Study Overview File Upload.”
At this point in the study development the IRB-SBS recognizes that you may not know the exact date for completing your study but knowing an estimated time frames helps our reviewers understand the scope of your study. If you continue the study for additional years, you will be able to modify these dates so that they continue to reflect a relatively accurate timeline.
Understanding the funding sources helps the IRB-SBS to evaluate any conflicts of interest as well as coordinate with other UVA offices. For more information, see Study Funding and the IRB.
This question is an opportunity to provide the overall thesis of the study and describe what the research hopes to accomplish.
With this question, the IRB-SBS needs a general outline of the study plan including information about where and when the study will take place. If there is more than one phase, make sure to outline each phase. The IRB-SBS reviewers will compare this information with your consent forms, data collection methods, etc, so it’s important to be accurate and consistent.
This upload allows you to provide the IRB-SBS with additional documents that will help them to better understand the protocol. The study overview file upload isn’t required and not all studies will find it useful; if a study involves new and/or complicated technology, for example, it may be useful for the IRB-SBS reviewers to have additional images, etc, to help them better understand the technology used in the study. For help with uploading documents, see Tips for Uploading Documents.
Remember that this is only the first section of the protocol and you should only be providing a summary at this point in the study. You will have additional sections where you will be able to describe in more detail the participants, risks, benefits, data collection methods, etc. In addition, there are a few “associate tools” that allow you to create tables to show how the elements in the study interact with each other; for example, the tools associates participant groups with consent forms and data collection tools. There are additional areas to upload consent forms, data collection tools, etc, so only use the study overview file upload to upload documents that are appropriate for this section.