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Cayuse IRB Management Software

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4.0 - Updated on 12/13/23 by Davie, Michael

3.0 - Updated on 12/13/23 by Davie, Michael

2.0 - Updated on 12/13/23 by Kincaid, Robin

1.0 - Authored on 08/11/20 by Kincaid, Robin

The Cayuse IRB management software is replacing the Huron system as of Sept. 10, 2020. The new software will allow researchers to enjoy increased efficiency with 100 percent electronic preparation, submission, and routing of human research study protocols. Furthermore, the new software will meet all of the expectations of the revised Common Rule.

Visit the Rowan University Institutional Review Board website for more information about IRB. Please see the information below for help navigating and using the Cayuse IRB management software.

 

Table of Contents 

 

Get a Support Account with Cayuse Help to View Training Materials

To view the majority of the training videos and articles available for Cayuse, you will need to create an account with the Cayuse Help Center. To create your help account visit https://support.cayuse.com/.

  1. Click New to Cayuse Support? Sign Up.  
  2. Enter your full name and email.  
  3. Click I'm Not a Robot.  
  4. Click Sign Up.  
  5. Check your email for a welcome email. Click on the link provided within the welcome email. 
  6. The welcome screen will have the full name you entered and will prompt you to set a password. The password must be 5 characters and must be different from your email address. You can choose a different password than your Rowan password, if you like.  It is important to know this account will be separate from your Rowan account even if you use the same username and password.



  7. Select Human Ethics as the product. You can now explore the Cayuse help site to see what videos and help articles are available to you. The website separates the articles and videos by the following roles: researcher, analyst and administrator. It is recommended that you bookmark this site on your browser for easy access.




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Get a New Cayuse IRB Account

To obtain a new Cayuse IRB account and begin the process of creating a new study, first navigate to the Rowan IRB website and select the link at the top of the page for Accessing Cayuse IRB.  Follow directions for either a new Cayuse user, or an existing Cayuse user who is submitting a new study if you already have a Cayuse account. 

 

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Initial Researcher Preparation

Upon gaining access to Cayuse IRB, please visit the Rowan IRB website for guidance submitting an initial study. Rowan students can view the checklist to use as a guide for submitting an initial study. There are many resources on the IRB website to help prepare researchers for conducting research, understanding the new common rule, and using protocol templates. 

Note: Update 'view the checklist' link with revised student submission checklist document dated 06/16/2022

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Accessing Help Videos from within the Cayuse Application 

If you are already using the Cayuse IRB application and need guidance, help videos and articles are available from inside the application. To use the training materials in the help area of Cayuse, click on the orange circle with the question mark in it on the lower right-hand side of the screen.

  1. Click the Orange Circle with Question Mark in it
  2. Click on Help Center in pop-up window 
  3. When the Help window appears, select the category to see videos and read articles or type in the search terms you are looking for to bring up
         video and article links

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Researcher Dashboard and Navigation Training 

There is a comprehensive overview video for Cayuse IRB researchers. You must have a Cayuse Help Center account before you can watch the training videos. If you are having trouble accessing the video, make sure you have created your Cayuse Help Center account first, and are logged into the help center when you access this video.



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Create a New Study 

Visit the Cayuse Help Center for help creating a new study as a researcher. The help article will walk you through all the steps required to enter study information and begin your new submission.

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Create an Initial Submission

Once you create your study you can submit the study to the IRB. There are guidance documents on the Rowan IRB website for submissions and required documentation. The Cayuse Help website has complete instructions on creating a new submission in IRB



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Review, Return, and Certify 

After you create a study it needs to be reviewed and certified by the Principal Investigator named in the submission. Prior to PI certification, edits can be made to the submission as directed by the PI or by the PI themselves and after revisions are made, the study must be certified by the PI to move it to Organization Approval (if your faculty PI has that set-up in Cayuse IRB) and then upon Organization Approval the study protocol CIRB submission will go to the Rowan IRB for review. The submission process provides an opportunity to make any necessary changes, as well as upload required documentation. Visit the Cayuse help center for complete instructions on how to review, return, or certify your submission.



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Departmental Reviewers

If you are a departmental reviewer and you need help logging into the system and completing review notes, please visit the Rowan IRB website to view the instructions specifically for departmental reviewers.

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IRB Analysts 

As an IRB analyst, visit the Cayuse video introduction page first. Make sure you are logged in to the Cayuse help website to view the video. You will find additional help with certifying submissions, adding attachments, and assigning an analyst on the Cayuse help page.

Visit the Cayuse help center article for help logging decisions for Limited IRB Reviews. Visit the help center for a breakdown of decision selections that includes explanations on each decision. The help center also has an article that shows how to create meetings and enter decisions

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IRB Reviewers and Approvers

As an IRB Member who is reviewing and approving, first visit the video introduction page. Make sure you are logged in to the Cayuse help website to view the video. Once you have been assigned a submission to review, you should receive an email notification. When you enter Cayuse IRB, you may need to change your role in the system. Visit the Cayuse help center for help changing your role. The article also covers reviewing a submission using the checklist and commenting on submissions. 

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Understanding System Messages and Emails

Cayuse sends emails when action needs to be taken within the system. Emails and messages are also triggered by actions performed in Cayuse. Visit the Cayuse help center for more information about understanding a message or email you have received


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Cayuse Administrators

IRB Coordinators will need to know how to manage users, assign roles to users, and perform basic administrative tasks in the Cayuse system. Visit the Cayuse help center for help assigning users to roles. The article also includes role definitions according to Cayuse.  Please visit the system administrators help page for a generalized system administrative guide. Make sure you are logged in to the Cayuse Help website to view the page.  


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Creating a Report

Cayuse has the ability to generate custom reports with study information for Administrators and Analysts.  To run a report, the user chooses from various fields, previews the report, and then runs the report to generate a custom CSV file that can be opened in Excel.  Visit the Cayuse help center for help generating reports, including information about outlining reports and the fields used to customize reports.  


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Organization Approvers / Departmental Reviewers

If you are an organization approver / departmental reviewer and you need help logging into the system and completing review notes, please visit the Rowan IRB website to view the instructions specifically for organization approvers / departmental reviewers. The role in Rowan Cayuse IRB is Organization Approvers.


Acquiring Cloud Computing Resources for Researchers Information Resources and Technology and the Division of Research 

Information Resources and Technology (IRT) and the Division of Research recognize the need for computational researchers to be able to utilize various cloud computing based resources in pursuit of their research goals. While the University’s Cloud First initiative is intended to address broader adoption of Cloud Computing across the business and academic units of the University, our institutional cloud presence has yet to be standardized. Many of the technical controls that are integrated into on-premises, datacenter based computational resources including Identify and Access Management, firewall and traffic management, security scans and monitoring, and data backup are not yet available in a University managed public cloud environment.

The list of questions below are presented as a supplement to the standard Information Technology Acquisition Process (ITAP). In coordination with that process, these questions will provide IRT and the Division of Research with the detail necessary to develop administrative guidelines for individual initiatives and to assist researchers through the process of acquiring public cloud resources.

The intent of this expanded ITAP process is to meet the administrative and compliance needs of the University while enabling individual researchers to access public cloud resources where possible.

In order to submit your ITAP request please visit support.rowan.edu, select “Request Something”, “Software”, complete the form and attach a completed version of this document. Once the ITAP request has been reviewed IRT and the Division of Research will provide you with a shared services agreement outlining the management of your public cloud environment. The corresponding ITAP approval can be used to complete your requisition with Purchasing.

1.) Please provide a brief outline of your research project including a summary of your expected computing needs. Please identify which portions of your research and data will utilize the requested cloud environment. If your request includes classified datasets or introduces other information security or compliance related challenges you may be advised to target a smaller scope in order to expedite the initial deployment of your cloud environment. Note: Examples of complex requirements may include HIPAA datasets, research subject to export controls, collaboration with DoD third-party individuals with strict security requirements, etc. AWS, GCP and Azure are not considered HIPAA compliant by the University at this time.

2.) What is the funding source for your anticipated cloud computing acquisition (Grant, Faculty Start-up funds, Other): a.) If available, please provide a Cayuse reference for your grant: b.) If available, please provide all FOAPAL numbers for this request:

3.) Is there a requirement for the provisioned cloud environment to exist beyond your current funding source? If so, how do you plan on funding this extension?

4.) What is your expected annual spend (if variable by year please provide projected cost by year)? (Note: There are tools available on the cloud-based websites in order to calculate this amount.)

5.) How long do you expect the provisioned cloud services to be in use?

6.) If appropriate, please include or attach the Data Management Plan portion of your grant proposal.

7.) What public cloud based service provider do you intend to acquire (Amazon Web Services, Azure, Google Cloud Platform, other):

8.) What specific services do you plan to consume from the provider(s) specified:

9.) What data do you plan to process or store in the public cloud services? Please provide a detailed explanation regarding the origin, type and confidentiality of the data.

10.) Are there any known compliance requirements related to the data you intend to process or store in the public cloud resources (HIPAA, FERPA, DoD etc.)? Please describe.

11.) Is the Data you intend to process or store in the public cloud environment subject to export controls?

12.) Do you require access to any Rowan resources from the public cloud environment? Please describe.

13.) Please describe the individual collaborators, both internal and external to the University, that may require access to the provisioned cloud environment. This may include faculty, professional staff, support staff, graduate assistants, students and/or external research collaborators (please list the institution for external collaborators). If a named list is available please provide here, including email addresses. You may be required to follow the Affiliate process for individuals external to the University that require access to the provisioned cloud services.

a.) What levels of access do these collaborators require within the provisioned cloud service (i.e., administrator access vs. user level access)

b.) How do you intend to manage the list of collaborators and their rights to the services and data you plan to process or store in the provisioned cloud environment? Possible options include provisioning the collaborators with access to Rowan’s services via affiliate accounts, managing the group of internal individuals with RIMS (Rowan Identity Management System) functional orgs and Active Directory groups, or providing external collaborators with direct access to the provisioned cloud environment and enforcing access permissions manually within the cloud service console.

14.) How do you intend to backup and protect the data you plan to process or store in the provisioned cloud environment?

15.) Do you intend for any of the services you configure in the provisioned cloud environment to be directly accessible to individuals other than your collaborators? Examples may include hosting a publicly available website or configuring a service that will be accepting connections from IoT devices over the Internet.

16.) How do you plan to recover the data stored or processed in the provisioned cloud environment at the end of your grant or current funding?