After Approval
When study procedures or personnel change, you will need to submit a modification.
Modifications on non-exempt studies must be approved by the IRB prior to changing the study. Common reasons to modify a study include:
- When key personnel are added to or removed from a study. It is the PI’s responsibility to ensure all personnel have CITI training prior to adding them to the study.
- When researchers update the techniques, recruitment, survey questions, assessments, compensation, or other methodologies in an approved IRB study.
Modifications on exempt studies do not need to be reviewed in most cases. Please see “Exempt Research” on the Resources and Guidance page.
Select a button below to access available PERA IRB training:
If an adverse event or something unexpected occurs, you must notify the IRB.
Review “What are my obligations after IRB approval?” and “What if something goes wrong with my study?” in HRP-103 – INVESTIGATOR MANUAL to determine if you have a reportable event, noting that non-compliance and serious adverse events must be reported to the HRPP/IRB office within 48 hours of the investigator learning of the incident.
Reportable New Information (RNI) must be submitted in PERA IRB. Anyone can submit an RNI on any study at any time. See PERA Training — go to IRB, then look for the RNI tile.
Use the button below to report anonymously via Purdue’s Hotline.
Exempt research does not require renewal or continuing review by the IRB.
Other approved studies, depending on conditions set by IRB, may need to be renewed. Studies reviewed by expedited review will need to submit a Continuing Review every three years to ensure the study is still ongoing and in good standing.
Studies that require a Continuing Review will need to be renewed at least annually by submitting a Continuing Review in PERA.
To ensure uninterrupted approval, be sure to submit your continuing review at least 30 days prior to the study’s expiration date.
After you have completed your research, you will need to close the study. You can close your study when the following are all true:
- Study is permanently closed to enrollment or was never open for enrollment
- All subjects have completed all study-related interventions
- Collection of private identifiable information is complete
- Analysis of private identifiable information is complete
NOTE: You may still analyze de-identified data and publish when the study is closed.
In most cases, study data should be kept in a secure location (hard copy and electronic) for a minimum of three years. Some retention times may be longer; contact IRB should you have questions. HRP-103-Investigator Manual outlines your responsibilities after study closure and if you leave Purdue.
Routine review is a necessary component of an IRB study and contributes toward the shared goal of human subject research protections. Monitoring is conducted in accordance with Purdue University HRP-096-SOP- Post Approval Monitoring. In-person reviews are conducted between the Post-Approval Monitoring Administrator and research personnel to confirm that all measures are documented appropriately in an IRB approved study.