IRB Reporting Forms for Approved Research Projects
After a project is approved, the IRB must receive updates from the researchers, regarding the status of their study.
Final Study Report
Once the study is completed, submit:
This form must be submitted electronically.
Amendment/Modification of Research
If the study is not completed within a year, a change occurs in the approved research criteria, or data collection continues for more than twelve months after the last IRB approval, submit:
Study modifications include:
- change in personnel
- change in number of participants
- revised informed consent
- revised methodology, or instruments used in the study.
Amendment/Modification of Research Form is required for all approved research projects in which data collection continues for more than twelve months after the last date of IRB approval.
Adverse Event Report
If an adverse event occurs during the study, the Adverse Event Report Form below must be submitted immediately:
For examples of adverse events, see the Adverse Event Report Form.
Contact the IRB Chair and Associate Provost with any questions about responding to adverse events.