After Approval

Research evolves over time. Therefore, your approved protocol may require revision to update procedures or add personnel. You also may need to renew your protocol depending on it's type. Finally, when a project ends, you will need to close your protocol with IRB.

If anything in your protocol changes or something unexpected occurs after approval, you will need to either amend your protocol or notify IRB

Typically, there are two reasons to amend your approved protocol and one reason to notify IRB:

All submissions MUST have a Cover Page for IRB Submission signed by the principal investigator.

Changing Personnel

Used when key personnel are added or removed to a project or removed from a project. Click here for the Amendments to Approved Study Form. You will also need to fill out and submit an Amendments to Approved Study form.

Changing Procedures

Used when researchers update the techniques, survey questions, assessments, or other methodologies in an approved IRB protocol. Amendments must be approved by the IRB prior to changing the study. Click here for the Amendments to Approved Study Form

Reporting Adverse Events or Deviations

Promptly report any adverse events or deviations to the protocol if they occur. When should I report problems to the IRB?

Click here to report on unanticipated and/or adverse events.

Click here to report a protocol deviation or noncompliance.

Some approved protocols require periodic IRB renewal

Research that has been determined to be exempt does not require renewal by the IRB.

Other approved protocols, depending on conditions set by IRB, may need to be renewed. Click here for the renewal form.

To ensure uninterrupted approval, be sure to submit your continuing review form prior to the study’s expiration date!

Post Approval Monitoring

Routine review is a necessary component of an IRB protocol and contributes toward the shared goal of human subjects research protections. Monitoring is conducted in accordance with Purdue University HRPP Standard Operating Procedure 306, “Post Approval Monitoring”. In-person reviews are conducted between designated post-approval monitoring staff and research personnel to confirm that all measures are documented appropriately in an IRB approved protocol.

Click here to review the forms that are part of the post-approval monitoring process.

When you’ve completed your research, you will need to close your protocol with IRB

After you have completed your research, you will need to submit a Study Closure form. In most cases, study data should be kept in a secure location (hard copy or electronic) for a minimum of three years. Some retention times may be longer; contact IRB should you have questions.

If you have any questions about these processes, please contact

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