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

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

2 Table of Contents: Home Page Apply New New Applications List Navigation Notes Project Info Project Team Info Application Specific Tab Errors Attachments Logs Submitting an Application Finding a Submitted Application Returned Applications

3 Home Page Apply New Click Apply New to begin a new ethics application, external grant registration, or internal grant application.

4 ROMEO is divided into two modules: CHEO Research Ethics Board and CHEO Research Institute (Awards / Contracts). These modules are independent of each other.

5 For the purpose of this example, we will use the Prospective Studies Involving Minimal Risk application. Information specific to each application type is available in the ROMEO Manual.

6 Navigation Notes Applications are divided into tabs. These will be referenced throughout the manual A red asterisk indicates a mandatory field. If you leave these questions blank you will not be able to submit

7 Project Info Type your project title here Select any relevant key words from the drop-down menu and click Add If you have already created an awards file for this project, click Search. If not, move on to Project Team Info.

8 Project Info linking awards file Click [Select] to choose the associated REB submission. The certification will then appear in the Related Certifications area of the Project Info Tab.

9 Project Team Info Be sure to save your application often! If you are completing this on behalf of the PI, click Change PI. If you are the PI completing this form, continue to Other Team Members. Note for REB applications only CHEO affiliated investigators may submit as PI. Residents, fellows, or trainees must list their supervisor as PI.

10 Project Team Info Change PI Type the PI s last name in here and click Search Choose the correct PI and click Select

11 The PI information will now be updated with the new PI

12 Project Team Info: Other Project Members If you have just changed the PI, you will need to add yourself back in to the project to continue accessing the file. You will also follow this process to add additional team members (co-investigators, administrators, coordinators, collaborators) Click Add New in the Other Project Member Info section at the bottom of the Project Team Info tab.

13 Click Search Profiles Type the team member s name in here and click Search Choose the correct individual and click Select

14 The researcher profile of the selected individual will load. Use the drop-down menu to select their role in the project Once updated, click Save. If one of your team members is not available on the list, contact Beth Gillis.

15 Once a team member has been added, they will be updated on the project team info tab. Be sure to repeat these steps to add all CHEO-Affiliated Researchers, Coordinators, and Administrators.

16 Application Specific Tab Most applications have a Checklist tab which contains a list of commonly required documents for this application type. Each application will have a tab with questions specific to the application type. If you require clarification on a question in an REB application, contact the REB office. If you require clarification on a question in an awards application, contact the awards office.

17 Errors Any required fields that have not been filled out will be listed in the Errors tab. In this tab, you will be told the following information about all blank required fields: Tab -> Subtab: Question

18 Errors Once you have responded to all of the required questions, the Errors tab will disappear.

19 Attachments All documents pertaining to your study should be appended to the application in the Attachments tab. Please reference the list in the Attachments tab or the Checklist in the Application specific tab for suggested documents.

20 Attachments Signature Page All REB submissions require a Signature Page. This can be found at the bottom of the signature tab or on the REB website. New REB Applications require signatures from any impacted departments, including the Lab and Pharmacy. Be sure to factor this in to your submission timeline.

21 Attachments To attach documents to your submission, click Add Attachment The document description should be written as you would like it to appear in your approval letter, and should include version date and version number. The version date should be the date the document was finalized. This is not necessarily the date the application was submitted.

22 Attachments If you are unable to find the desired document type, select Other Document. When all of the information has been populated, click Add Attachment.

23 Attachments Repeat these steps to attach all of the relevant study documents.

24 Attachments 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.

25 Logs The log is divided into three subsections: Application Workflow Log: Notes and communications involved in the submission and evaluation process. Application Log: Application data entry trace Shared communications: Copies of all communications with the awards or REB office. Includes approval letters available to download and print.

26 Submitting an Application Only individuals listed as PI will be able to submit the application. If you are listed as a Project Team Member, the submit button will not be visible.

27 Submitting an Application Once the PI has reviewed and approved the submission, they may click Submit.

28 Submitting an Application 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. The comment will appear in the Workflow Message and can be used to identify the file s movement.

29 Finding a Submitted Application Before the application has been accepted for review, it is found in Applications: Under Review. Once it has been accepted for review, the application will be found in Applications: Post-Review. Changes cannot be made to the submitted application unless it is returned by the appropriate office.

30 Returned Applications If your application is returned by the REB or Awards office, the Applications: Requiring Attention quicklink will be bold and red. Follow the link and view the log for details on why your submission was returned.

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

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