As previously announced, the Version 4 (V4) system update on August 18, 2022 encompasses improvements to the IRB application’s readability by reducing redundancies; re-organizing some of the sections; and improving navigation for some of the menu options, visuals on section pages, and the log-on page.
- E-IRB applications submitted to ORI/IRB before noon on August 18, 2022 will not contain the updates.
- This includes applications in the researcher’s Inbox (default Dashboard view) and on ORI’s or the IRB’s Dashboard.
- After your application is approved, creating a new Modification Request or a Continuation Review/AAR request will convert the application to the updated version (V4) then.
- All E-IRB applications in draft and not submitted to ORI/IRB by noon on August 18, 2022 will automatically be converted to the updated E-IRB application (V4).
- No previously saved data or attachments will be lost;
- There are several sections with a text field being moved to a different section and combined with a similar question. The contents of the two text fields will be merged together. The researcher is responsible for reading through the resulting combined text to make edits as deemed necessary for optimal comprehension.
- The nine sections directly affected by the system update are:
- Subject Demographics
- Informed Consent/Assent Process/Waiver
- Research Description
- Study Drug Info
- Study Device Info
- Research Sites
- Research Attributes
- Additional Information/Materials
If one or more of these nine sections had a check mark before noon, August 18th, the section will lose the checkmark after the conversion to V4. A blue check mark indicates the section is complete while a pencil icon signifies that additional information/verification is required.
The researcher is responsible for going through the application to make sure all sections have a blue check mark next to them rather than a pencil. If any section in the application has a pencil icon next to it, it means there is missing information (e.g., a new question was added). The researcher will need to review the section and answer the required questions and save the section before being able to submit the application.
As always, we appreciate your patience through the transition and hope you find the changes beneficial.