吉祥坊

Renewal and Modification Process听

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

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

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

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

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;听

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

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

4. Any relevant multi-center trial reports;听

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

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

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

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

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

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 鈥渢rack changes鈥� function in Microsoft Word.听

Common documents that are typically affected by modifications are:听

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

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