» Cayuse IRB

Submitting an IRB Protocol

Chapman University Institutional Review Board has now switched to Cayuse IRB production system, for submission and processing of human subject research studies (protocols) in accordance with Chapman University, federal, ethical, and regulatory standards. 

The Cayuse Institutional Review Board (IRB) module is an easy-to-use system for electronically preparing, submitting, and routing studies for IRB approval. All information is stored in the cloud and can be accessed securely from any location, making it simple for multiple simultaneous users to view and share documents.  Users receive electronic notifications whenever an action is required on their part, allowing the study to proceed smoothly through each step of the process from study creation to final approval.  

More information on all submission types available in Cayuse IRB can be found below in the Submission Types tab.  Step by step instructions on how to submit new and additional protocols, and complete Organizational Approval can be found on the Training tab below.

*Cayuse IRB runs on Internet Explorer 9 or higher, Mozilla Firefox, Google Chrome, or Apple Safari.

+ - Expiration and Renewal Notices

All Expiration and Renewal Notices are being emailed through Cayuse IRB production site. Cayuse IRB will send reminder notices 60 and 15 days before a protocol expires, so that the PI(s) have adequate time and opportunity to renew the expiring protocol. NOTE: It is the PI's, not the IRB’s, responsibility to renew his/her protocol before it expires.

PIs can begin renewal submissions once their legacy submission is completed by the IRB office. The legacy is used for studies imported from previous systems and replaces the initial submission for imported studies. Once the legacy submission is finalized, PIs can create additional submissions such as modifications, renewals, etc. 

+ - IRB Member Review

If you are an IRB member, see here for instructions on how to review in Cayuse IRB.

+ - Submission Requirements

Before beginning a submission users should have the following items ready:
  • Supplemental documents in individual document files (i.e. informed consent forms, authorizations, approvals,  recruitment documents, questionnaires, etc.). Files can be in various formats (PDFs, docx) however, PDF files are preferred.  All templates can be found on the Consent Forms page.
  • Copies of CITI training reports/certificates of principal investigator, faculty advisor, co-PI(s), student investigators, and engaged research personnel 
  • All users "authenticated" in the Cayuse IRB system
    • For more information, please see the Authentication tab

+ - Authentication

If this is your first time submitting an IRB protocol in Cayuse IRB and/or are receiving the following message at log-in "We're sorry. This account has been disabled on the Cayuse424 system", please email the following information to irb@chapman.edu requesting authentication for Cayuse:

  • First and Last Name
  • Chapman email address (e.g. NAME100@mail.chapman.edu)
  • Status (faculty, staff, student, unaffiliated, etc., as appropriate)
  • Chapman University College and Department

All student directed studies must submit a list of student names and above information to the IRB office prior to beginning a submission.  

For studies that have students as research assistants, but are not directing the study, authentication does not need to happen.  The research assistant names may be listed on the application along with other Chapman Researchers (Investigators) engaged in the research. 

Once the office creates the authentication, the system needs to update overnight before the PI can access his/her account in Cayuse IRB.

When you work in Cayuse IRB, should you see a data entry mistake from authentication, based upon the information you provided, please email irb@chapman.edu with the correction to be made.

+ - Training

Please find below several Instructional Powerpoints on how to use Cayuse IRB

As applicable, be sure your collaborators, including a faculty advisor, also authenticate as a user in Cayuse and have CITI training.  Should you need to obtain a CITI report, go to Training and Continuing Education.

+ - Submission Types

InitialThis is the first submission that you create when you enter a new study in the system. The initial submission describes the research you intend to do and the methodology you intend to use. The initial submission must be approved before any research can begin.

Withdrawal- A withdrawal submission notifies the Integrity Office that you no longer wish to submit your initial submission and want to withdraw the study. Withdrawn studies are marked as finalized and can no longer be modified. You may create a withdrawal submission at any point once an initial submission has been created, until it has been approved. If the initial submission has been approved, you must create a closure submission in order to close the study if you no longer wish to conduct the research.

LegacyUsed for studies imported from previous systems. The legacy submission replaces the initial submission for imported studies. Once the legacy submission is finalized, you can create additional submissions such as modifications, renewals, etc. 

Modification If you wish to change any of the details of the study after it has been approved, you must submit a modification which must be approved before you can proceed with the changes. Modifications will only be available after initial approval is issued.  Modifications will be linked with the initial application and you will make revisions to the initial application based on the modifications you are requesting.

RenewalWhen a study is nearing its expiration date, you must submit a renewal request in order to continue with the research. Expiration notices will be emailed from Cayuse.  Renewals, like modifications, will only be available after initial approval is issued.

Incident- You must submit an incident report to inform the Integrity Office of any adverse incidents, as required by your institution. Incident reports may be submitted at any time after a study has been approved, including after it has been closed. More than one incident report may be created for a given study, as needed.

ClosureA closure submission indicates that the research is complete and will not be continuing. Closed studies are marked as finalized and can no longer be modified.