Protocol Modifications/Renewals

Renewal and Modification Process 

1) Renewal or Modification for protocols that were initially submitted in Cayuse:  These studies will have an IRB number in the format: IRB-FY19-### 

Please use the Cayuse Native renewal and modification process.  Log into Cayuse IRB and enter the Study Details section for your study.  On the top-right of the page will be a blue button that says “+ New Submission”.  Click on this and chose “Renewal” or “Modification”, and then complete the submission form, submit and certify.  Renewals and modifications can no longer be completed with one form, you will have to start a separate submission for each one.   

2) Renewal of protocols that were previously approved on PDF and have not expired: These studies will have an IRB number in the format 1718-###-x 

To renew a protocol, please submit a cover letter outlining the need for the renewal, and include the following: 

1. The number of subjects accrued since the last IRB review of the protocol and (for ongoing studies) the total number accrued for the study; 

2. A summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since last IRB review; 

3. A summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review; 

4. Any relevant multi-center trial reports; 

5. Any other relevant information (especially information about risks associated with the research); 

6. A copy of the current informed consent document (without the approval stamp) and any newly proposed consent documents; and 

7. Any other changes to the study (e.g., personnel, measures, procedures, etc.) 

Please submit your renewal request with the above documentation via email to   at least  30 days before the protocol expiration date.  Studies that have expired will need to be re-submitted as new protocols through Cayuse IRB. 

3) To modify protocols that were previously approved on PDF and have not expired: These studies will have an IRB number in the format 1718-###-x 

To request a modification to your protocol, please submit a cover letter briefly outlining the newly proposed changes and the need for the modification. In addition to this letter, all appropriate documents that are affected by the modification will need to be submitted. Please indicate the new and/or modified content using the “track changes” function in Microsoft Word. 

Common documents that are typically affected by modifications are: 

• Consent Forms (Adult, Parental, Adolescent/Child) 
• Recruitment Materials 
• Data Collection Materials 

Please submit your modification request via email to irb@csun.edu. Studies that have expired will need to be re-submitted as new protocols through Cayuse IRB.