Responding to REB Feedback

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1 Responding to REB Feedback A ROMEO Hasty Handbook Presented by the CHEO Research Institute

2 Table of Contents: What is REB Feedback? The REB Feedback Letter The Investigator Response Letter Finding the ROMEO File Accessing the Events Selecting the Correct Event Event Info Tab Investigator Response Tab Attachment Tab Adding an Attachment Submitting the Investigator Response

3 What is REB Feedback? All studies submitted through ROMEO are reviewed by the REB or a delegate from the board. This review often results in feedback or points of clarification requested by the REB. Once your study has been reviewed, you will receive an from the REB containing an attachment with your study s feedback.

4 The REB Feedback Letter The REB s requests will be itemized in the feedback letter. This is sent in a Word document and research teams may pull the feedback points directly from the REB letter into their response.

5 The Investigator Response Letter Research teams are encouraged to copy and paste the feedback points from the REB s letter into their response cover letter to create an organized and complete response.

6 Finding the ROMEO File Feedback is submitted as an Event to the ROMEO application. Type the eight-digit ROMEO File Number from the feedback into the ROMEO search bar and click the magnifying glass

7 Accessing the Events This will bring you directly to the application in question. To move forward with creating the event, click Events.

8 Selecting the Correct Event Select Investigator Response to REB Feedback from the list of New Events

9 Event Info Tab The Notes Section allows you to easily identify your submission. Any comment made is visible in the Drafts section of the Events Page.

10 Investigator Response Tab Complete all questions on the Investigator Response tab

11 Attachment Tab Attach all documents modified or created as a result of the REB s feedback. Ensure to attach clean and tracked versions of all modified documents Click Add Attachment to attach your first document

Adding an Attachment Insert a description of the document as you would like it listed in the approval document. Note: The version number should not change until the REB has approved the document.

12 Adding an Attachment Insert a description of the document as you would like it listed in the approval document. Note: The version number should not change until the REB has approved the document. If this is in response to feedback on the initial application, the protocol version will remain as 1. List the Version Date as the date the document was finalized, which may not be the date it was submitted. When all fields are complete, click Add Attachment.

13 Adding an Attachment You may change the Doc / Agreement, Version Date, or Description by clicking Edit. If you must change the document attached, click Delete and re-attach the correct file Be sure to attach an itemized investigator response letter

14 Submitting the Investigator Response Once the response has been reviewed, you may submit. Any member of the research team is able to submit this event.

15 Submitting an Investigator Response When you click Submit a comment box will appear. If you have a comment, type it in here. If you do not, click any key and Submit. Note the comment will appear in the Workflow Message and can be used to identify the response.

16 Visit the ROMEO page on the CHEO RI Website for more tools and resources.

Creating a New Application. A ROMEO Hasty Handbook Presented by the CHEO Research Institute

Creating a New Application. A ROMEO Hasty Handbook Presented by the CHEO Research Institute Creating a New Application A ROMEO Hasty Handbook Presented by the CHEO Research Institute Table of Contents: Home Page Apply New New Applications List Navigation Notes Project Info Project Team Info Application