Once your study has received approval, research activities can begin.
Throughout the course of the study, Principal Investigators (PIs) are responsible for submitting the following.
Modification Submission
For any changes, including changes in funding status or research personnel. Minor language adjustments are the only changes that can be addressed without formal modification.
Incident Submission
To report any adverse events, protocol deviations, unanticipated problems, subject complaints, and other safety information meeting UCSC IRB reporting criteria.
Renewal Submission
At least 30 days before the study’s administrative check-in date or expiration date.
Closure Submission
When all activities involving human subjects described in the approved study are completed. This includes research-related interaction/intervention with subjects and analysis of identifiable private information (data).