» 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 these instructions that explain how reviewers 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, see the Authentication tab.

+ - Authentication

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

  • 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 include student research assistants who will not direct the study, authentication is not required.  The research assistant names may be listed in the Cayuse submission, along with other Chapman researchers (investigators) engaged in the research. 

Once the IRB Office authenticates the researchers' profiles, Cayuse will update overnight before the researcan access his/her account in Cayuse IRB.

If a data entry mistake was made regarding your information, you can request that a correction be made by emailing the IRB Office at irb@chapman.edu.

+ - Training

Below are instructional powerpoints that explain how to use Cayuse IRB:

Be sure all members of your research team, including faculty advisors for student-directed research, also authenticate as users in Cayuse and have completed CITI training.  For information and instructions regarding CITI, visit the Training and Continuing Education page.

+ - Submission Types

Initial

This 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.

Legacy 

Used 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.

Renewal

When 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.

Closure

A 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.