Protocol Submission

Introduction 

Please note:

Effective with the Spring 2020 semester Faculty and staff began submitting research protocols using using the Cayuse IRB online submission system.

Student research protocols may continue to be submitted via email or hard copy until the beginning of Summer session 2020, after which, all protocols must be submitted via the Cayuse system.

Please see also the IRB Training Materials and Detailed Instructions below.

 The is an online human subject research application management system used to electronically prepare, submit, and route research studies for IRB approval. All information is stored in the cloud and can be accessed securely from any location, making it simple for researchers/investigators to upload, edit, and submit human subjects research studies. Users receive electronic notifications whenever an action is required on their part, allowing the study to proceed smoothly through each step of the review process from study creation to final approval.

Faculty and Staff User Access: CSUEB faculty and staff have access to the Cayuse system automatically through their single sign-on ID (NetID.)   If you are unable to log into the system, please email irb@csueastbay.edu to request access, and include your NetID, your CSUEB email address, and your department. Once your information is entered into the system, it takes 24 to 48 hours for the Cayuse IRB system to update and allow you access.

Student User Access: CSUEB students do not have access to the Cayuse system by default.  To request access, please ask your faculty advisor to email irb@csueastbay.edu.  Your advisor should include your NetID, your CSUEB (Horizon) email address, and your department in the message. Once your information is entered into the system, it takes 24 to 48 hours for the Cayuse IRB system to update and allow you access.

Faculty Advisors: If you are teaching a course where you will be requesting access for all your students, please contact irb@csueastbay.edu for instructions on completing and submitting a template with all your student data at once.

External Investigators :  External investigators do NOT have access to the Cayuse IRB Online Submission system.  Please contact irb@csueastbay.edu for more information.

Cayuse IRB Login:

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Cayuse IRB Training Presentation

Instructions

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  • Submitting a new (Initial) application
    • Select New Study (blue button upper right-hand corner).
    • Enter the title for your study, then select the blue check-mark in the box - (please note the title cannot be changed once it has been entered).
    • Select New Submission (blue button upper right-hand corner). Select the option Initial which appears as a drop-down menu when you select the New Submission button.
    • Then select Edit to have access to the application (the Edit button is grey and should appear toward the middle of your screen).
    • Complete the IRB application.
    • Complete the submission (the Complete submission notification will appear at the bottom of the screen below section 11 of the application). You may need to scroll down depending on the size of your screen).
    • PI will be asked to Certify the submission. The Certify text appears in the middle of the screen which is blue and underlined.
    Please see New Submission guide for example screenshots.

  • Submitting a Modification (protocol change/amendment) to a previously approved study
    • Login to Cayuse IRB.
    • Select My Studies.
    • Select the study you wish to submit your modification (protocol change/amendment)
    • Select New Submission (blue button).
    • A drop down will appear with the option to submit a Modification.
    • Select Modification which gives you access to the form.
    • Select Edit.
    • PI will be asked to Certify the submission.
      • Please note that the modification must be approved by the IRB before you can implement the change to the study.
    Please see Modification guide for example screenshots.

  • Submitting a Renewal/Continuation request to a previously approved study
    • Login to Cayuse IRB.
    • Select My Studies.
    • Select the study you wish to submit your modification (protocol change/amendment)
    • Select New Submission (blue button).
    • A drop down will appear with the option to submit a Modification.
    • Select Renewal which gives you access to the form.
    • Select Edit.
    • PI will be asked to Certify the submission.
      • Please note that the modification must be approved by the IRB before you can implement the change to the study.
    Please see Renewal/Continuation guide for example screenshots.

  • Submitting a Protocol Closure request to a previously approved study
    • Login to Cayuse IRB.
    • Select My Studies.
    • Select the study you wish to submit your modification (protocol change/amendment)
    • Select New Submission (blue button).
    • A drop down will appear with the option to submit a Modification.
    • Select Closure which gives you access to the form.
    • Select Edit.
    • PI will be asked to Certify the submission.
      • Please note that the modification must be approved by the IRB before you can implement the change to the study.
    Please see Protocol Closure guide for example screenshots.

  • Following are links to a very simple, completed Cayuse protocol and supporting documents.   For CSUEB standard form templates, please see Forms and Templates.

    Example Completed Cayuse Protocol

    Example Parental Consent Form

    Example Letter of Permission from Principal

    Example Recruitment Letter

    Example Survey

 

Cayuse IRB User Support: If you are having difficulties accessing the system you may need to contact Cayuse User Support by sending Cayuse an email at support@cayuse.com.  You may also contact Cayuse User Support directly at 1-503-297-2108 ext. 1 or 1-877-689-3661 to assist you with Cayuse IRB access issues. Their website address is .  In order to access the support website, you will need to create an account on the site.  All faculty, staff, and students may create accounts on the support site if they wish.

User Help: Help is available within the Cayuse IRB system.  Wherever you see a "?" symbol, you may select the "?" for more information.

User Guides: The most up-to-date guides are available through the Cayuse Support Center website and training links above.   Additional older, but relevant, guides are found at the link below.