You must complete, submit and receive the approval of a modification form. Submit it directly to the IRB office. Please remember to reference your IRB log number. Not referencing your log number will slow down the process.

Yes. Complete the modification that is available from our website. When adding study personnel, please submit the CITI certificates for each individual researcher along with the modification form.

Once your project is approved you will receive notification regarding the approval period for your project via email. Level II and III studies must file a completed annual review form with the IRB office prior to the initial expiration date. These forms are also used to report adverse events and closures.

It is the responsibility of the investigator to be aware of the study expiration date and submit the required materials in a timely manner. The IRB will try to send you an annual review reminder notice by email as a courtesy.

A new application is needed if you are planning to change two or more of the following.

• Purpose
  
• Population
• Procedure
  

Yes. An investigator needs to inform the IRB that a study is being terminated or closed, and complete an Annual Periodic Review form. A study should not be terminated until all subjects have completed the study and research related activity has ceased, including subject follow up, data collection, and or data analysis.

You must submit a modification form (remember to include your proposed recruitment materials) and receive approval before modifying your efforts.