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ROMEO Form Updates

August 21, 2017
A new event form was created.  The form is used to submit requests to waive the requirement for French translation of participant documents in research projects.  A signature page was also created for this event.

March 22, 2017
A new application form was created. The form is for investigational device projects (Class II, Class III & Class IV).  It is not intended for projects that also include an investigational drug, biologic or NHP. A project that includes a combination of device & other regulated investigational agent should be submitted using the full Board application.  The stream of review (full Board or delegated minimal risk) will be determined by the REB based on the risk of the submitted project.  This will be done on a case by case basis.
 
The deviation event form was updated to include information regarding the date the deviation occurred. 

March 13, 2017
The prospective minimal risk application and the retrospective chart review & secondary use of samples application forms were modified to include additional questions.  The minimal risk protocol template, consent form template and letter for survey's template were modified.

January 20, 2017
Additional Co-Investigators &/or Research Staff
The addition of a co-investigator and/or research staff that does not modify any study specific documents (i.e., consent forms contact section), does not require submission to the REB office.  Please send an email to the ROMEO lead that indicates the CHEO REB study number, the name of the individual, their role on the study and indicate that there are no changes to study documents.  Please ensure that the additional staff has the appropriate training certificates as well as a ROMEO account; if they do not, the staff will not be added to the study.  


January 04, 2017
The full Board application was modified to include additional questions.
January 10  2017
The database application form was de-activated.  
The prospective minimal risk application form, Nature of the study tab was updated to include an option of database.

October 4, 2016
The system will not allow attachments to have the same file name within the same project. When this occurs the system will generate the
following error message “File already exists”.  We recommend saving documents with modified file names. For example, when submitting a consent form for annual renewal, modify the file name from “consent final” to “consent AR 2016” for uploading purposes. This will allow you to bypass the system error. Of note, please do not change the version dates within the footers or labeling of the document that is unchanged, except for the document title. 

June 27 2016
The REB must be advised of all changes in study status, which previously was submitted via the REB study closure form. The form previously encompassed study closures to accrual both permanently or temporarily suspended, as well as permanent study closure.
 
The REB has responded to feedback from ROMEO users, and has a NEW form:
  •  Change in study status (closed to accrual permanently and accrual temporarily suspended);
A signature page for change in study status can be found on the REB website (/en/studyclosure).
 
The following form was updated:
  •  Study Closure (permanent study closure): removed closed to accrual and accrual temporarily suspended  

April 26 2016
The REB Study Closure form:
Questions were removed in order to simplify the form.

April 1, 2014, all submissions to the REB are submitted electronically through ROMEO.
As the REB continues to improve its processes, updates to the forms within ROMEO will be ongoing. This page will be a forum to communicate any updates to the forms.  
 
If you have not received Romeo training, please email Elizabeth Gillis at egillis@cheo.on.ca. To access ROMEO, please use your user name and password.
The following link will take you to the ROMEO home page https://cheonet.cheo.on.ca/research-learning/research-institute/romeo. If you require any ROMEO assistance do not hesitate to contact Elizabeth Gillis.
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