Submitting New Study Applications

ALL Sunnybrook staff, particularly Principal Investigators, MUST register with their Sunnybrook email address. There may be exceptions for individuals without a Sunnybrook email, however requests are reviewed on a case-by-case basis.

Initial Application: Initial Application

Amendment: Includes any of the following:

• Protocol Changes
• Changes to Consent documents (Informed Consent/Assent forms, Information letters etc.)
• Changes to any other participant materials
• Updated Investigator Brochure/Product Monograph
• Translation materials
• Any other changes to previously submitted information

Continuing Review: Continuing Review – Submitted Annually

Change in Principal Investigator (PI): Change in Principal Investigator

Reportable Event: Includes any of the following:

• Reportable Internal Serious Adverse Event(s)
• Reportable External Adverse Event(s)
• Reportable Protocol deviation/violation
• Privacy breach
• DSMB reports
• Interim Analysis results
• Safety update from sponsors
• Inspection/Audit report
• Study participant complaint

Completion: Completion Report – Submit when there is no further participant involvement and all data collection, clarification and transfer is complete (including access to the participants’ medical record). Submission of this report indicates that these activities have ceased, the study does not require continuing ethics approval, and the Sunnybrook REB study file can be closed.

*If you are unsure which form to submit, please contact the REO office for guidance.

There are two options:

1. Within the submission, the Project Owner may click “Print” to save a pdf copy of the SunRISE form, which may be provided to the individual/committee.
2. The Project Owner may provide a “Role” to the individual or an individual from the committee in order to view the application online. The Project Owner has the option to provide read-only access.

Ensure these steps are done and the individual or committee reviews the application before it is submitted through SunRISE.

To sign the submission, access the appropriate study from your work area, click on Section 1, and then click on the “Sign” button on the top left hand side of the screen. Do NOT navigate to the signature section of the form to sign as it will be locked through the signature request.

If you are encountering issues with signing or submitting a form even after it has been fully completed, it may be that the project needs to be updated.

Access the submission through the work area and click on the blue “Update” button located at the top of the page. Please note, you must be the project owner of the study to update the submission.

If there is no “Update” option available, it may be that you are not the Project Owner of the study. To check the Project Owner of a submission, access the study from your work area and click on the Collaborators tab in the middle of the screen. This lists all current users with access to the study. The user listed as the Project Owner will have the ability to update the study.

If the Project Owner is no longer at Sunnybrook or no longer has access to SunRISE, please email: SunRISE@sunnybrook.ca for assistance.

Do not update projects that have already been closed or completed.

This notification will appear for projects and forms where there is a pending signature request. The form cannot be edited while a signature request is pending.

You may unlock the form at any time but doing so will invalidate all current signatures and all pending signatures requests.

This may be because there is already an outstanding, duplicate sub-form for this study. Make sure to complete all previously created sub-forms before starting a new one.

To check all existing forms associated with a submission, access the study from your work area and click on the “Project” button on the top left hand side of the page.

Yes, as per good documentation practices, it is very important to include the version date and/or number to the footer of the actual document.

For ease of review, it is highly recommended that submission documents to be uploaded as PDF files.

To save a Word or Excel document as a PDF, click File > Save as > under “Save as type” select PDF.

Research teams are strongly advised to save copies of all documents (including submission documents and the SunRISE forms) on their shared network drive. This is good practice and ensures teams have access to their documents at all times. The saved documents can also be provided to monitors during monitoring visits.

To save a copy of the SunRISE submission form, access the form through SunRISE and click “Print”. This allows you to save a PDF copy of the file.

1. A project?
   • If you are leaving and are the PI:
     • Submit a Change in Principal Investigator (PI) form for each project through SunRISE.  Once approved by the REB, follow step 1b) or 1c) below depending on whether or not you are also the Project Owner.  
   • If you are leaving and are the Project Owner:
     • Transfer the project(s) to the SunRISE user taking over the duties.
   • If you are leaving but are not the Project Owner:
     • Notify the Project Owner to remove your acccess through the “Roles” function.
2. Sunnybrook? 
   • If you are leaving and need continued SunRISE access:
     • Note: An institutional email address as well as written confirmation (e.g. email) from the Sunnybrook PI will be required for continued access.
   • If you are leaving and do not need continued SunRISE access:
     • Follow step 1a), 1b) or 1c) above depending on the scenario.  Then notify sunrise@sunnybrook.ca. 

*For steps on how to identify the Project Owner or how to transfer projects, access the SunRISE tipsheet.