iProtocol Guide

Study Overview Section

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.”

Anticipated Dates

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.

Funding

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.

What is the purpose in conducting this research?

This question is an opportunity to provide the overall thesis of the study and describe what the research hopes to accomplish.

What will participants do in the study?

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.

Study Overview File Upload

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.

  • For all of the phases or experimental conditions it is clear how participants will be assigned.
  • The experience of the participant is clearly described.
  • The investigator provides sufficient information to understand the theoretical bases for this study.
  • The multi-site research study management of information relevant to protection of subjects is describe or is not applicable to this study.
  • The expectations of the participants are reasonable for the study's goals.
  • The multi-site research study management of information relevant to the protection of subjects is appropriate or is not applicable to this study.
  • The overall concept of the study is reasonable and will likely yield the expected knowledge.
  • The research activities are reasonable in relation to the study goal.
  • The protocol is concordant with the funding proposal. (Federal funding only)