ROMEO User Guide
Contents
1. button to assign the PI to the protocol i Start with amp Any part Last Name holmes First Name Options Last Name First Name Primary Affiliation T T T select Holmes Sherlock Social Science Administration amp Info Studies Fig 8 The Pl s information will self populate Project Info Project Team Info Non Medical Form Attachments Logs Errors Principal Investigator Info Dr X Last Name Holmes First Name Sherlock Affiliation Social Science Administration amp Info Studies ha Rank Professor Gender Unspecified Institution X E Phone 1 555 1234 ext 1111 Phone 2 Email ethics1 uwo ca Fax Fig 9 NOTE If you cannot find your PI please contact the Romeo Helpdesk ethics romeo uwo ca 519 661 3049 Step 3 Add yourself as a team member in the Other Project Member Info section at the bottom of the screen Other Project Member Info Role In Project Research Support Staff Fig 10 Full Health Sciences Form Tab This is the bulk of the application and will contain all of the required information necessary for review by the Health Sciences REB Please go through each section and complete all of the questions that apply to your study Descriptive text at the top of each section will highlight the questions with important notifications provided in the blue information icons Project Info Project Team Info Full Board Health Sci2. Print _Exportto Word Exportto PDF Submit Project Info Project Team Info Full Board Health Sciences Form Attachments Logs Errors NOTE The maximum individual attachment size is 5MB All attachments larger than 5MB will stall the system and your data may be lost However you may upload multiple attachments provided that each is no larger than 5MB Attachment Description Version Date Doc Agreement _Edit Delete rile eo 2012 07 01 Letter of Information amp Consent _Edit Delete arei ir pamiera e Poster 2012 07 01 Advertisement EA Deki M Omne Reps ammamvodt cr go oe _Edit Delete a ee Company paf 2012 05 01 Protocol Sea oa SSP ence oe Edit Delete eated one 2012 07 23 2012 06 01 Other Edit Delete prar pieke a 2012 05 01 Investigator Brochure DE D oaa one 2012 07 23 2012 07 01 Other Save any changes that you have made to the protocol by selecting the Save button at the top left hand corner You can save the application at any point during the process of completing the form Once you have completed the application save your changes and export a copy of the protocol in Word format Save this document in a safe place as you will no longer have access to your original application once it has been submitted to the ORE for review Fig 13 SE i Application Saved Project Info Project Team Info Full Board Health Sciences Form Attachments Logs Errors Proj
3. Are you collecting personal identifiers for this study is required Full Board Health Sciences Form gt 7 Confidentiality and Data Security 7 16 Where will information collected as part of this study be stored select all that apply is required Fig 6 Project Info Tab In this section indicate the protocol title as well as the expected start and end date Also provide key words associated with the project Project Team Info Tab Initially ROMEO will auto fill the Principal Investigator PI section so that it corresponds with the individual that created the file or started the application As stated above the ORE will only except new study applications submitted from the Pl s account Therefore if you are a study coordinator or research support staff that has created the application you must assign the protocol to the appropriate PI Please see the example below in which the study coordinator Ms Jane Watson must assign the protocol to the PI Dr Sherlock Holmes Step 1 Select Retrieve Info Project Info Project Team Info Non Medical Form Attachments Logs Errors Principal Investigator Info Lr ine Prefix Dr X Last Name Holmes Affiliation Social Science Administration amp Info Studies Rank Professor bd Gender Unspecified Z Institution Fig 7 ROMEO User Guide Full Board HSREB August 2012 Step 2 Enter the Pl s name and select Search Click on the Select
4. uwo ca research ethics romeo ROMEO Resource Page Office of Research Ethics ROMEO Education Health Sciences REB Non Medical REB About Us Oreo by processpathways Fig 1 ROMEO is the knowledge management system used by the Office of Research Ethics to Manage Ethics protocols If you encounter any problems or need help with Romeo please check the resources below or contact the Romeo helpdesk at ethics romeo uwo ca or 519 661 3059 ROMEO User Guide Full Board HSREB August 2012 Logging into Romeo Using current email addresses on file the ORE has created default usernames for the majority of investigators and research support staff that have previously submitted to our Board The first time that you login you will need to set your password by selecting reset password and following the instructions provided Login Username ethics romeo uwo ca Password Po 5 ROMEO will send you an automated email with a confirmation code Copy and paste the confirmation code into the space provided and create your new password Fig 2 User Name ethics2 uwo ca Confirmation code Password Confirm Password meme i crcl Fig 3 If you do not have a valid username or are a new researcher you will be presented with a red error message instructing you to contact the ORE for assistance ROMEO Dashboard Once you have successfully logged in to Romeo you will be taken to the ROMEO dashboard This
5. ROMEO User Guide Full Health Sciences Research Ethics Board August 2012 ROMEO User Guide Table of Contents Getting Started with ROMEO p 2 4 Figure 1 ROMEO Resource page Figure 2 ROMEO Login Screen Figure 3 Confirmation Codes Figure 4 ROMEO Dashboard Creating a new application p 4 5 Figure 5 Choosing the Correct Form Figure 6 Error Tab Figure 7 to 10 Project Team Info Completing and submitting an application p 5 7 Figure 11 Information Icon Figure 12 Attachments tab Figure 13 Export to Word Post Review p 8 9 ROMEO User Guide Full Board HSREB August 2012 About ROMEO ROMEO is a secure web based knowledge management system that is hosted at Western on dedicated servers maintained by Information Technology Services ITS REB applications and supporting documents submitted through ROMEO will be kept confidential and maintained by the Office of Research Ethics ORE Access to this information will only be permitted for necessary review and oversight of research involving human participants Ethics applications for new studies and responses to Board recommendations must be submitted through ROMEO by the principal investigator ROMEO Help If you encounter any problems or need help with ROMEO please contact the Romeo helpdesk at ethics romeo uwo ca or 519 661 3059 You may also refer to the ROMEO resources section of the Office of Research Ethics website http www
6. cers Full Board Janice Sutherland 519 661 2111 ext 86764 jsuther uwo ca Full Board Shantel Walcott 519 661 2111 ext 87437 swalcot uwo ca Delegated Grace Kelly 519 661 2111 ext 84692 grace kelly uwo ca Please note that if the incorrect form is submitted you will be asked to create and submit a new application on the correct form Research Ethics Application Name Description The Full Health Sciences Research Ethics Board reviews all research that involves a clinical trial for drugs natural products or devices In addition this board reviews all research that involves the ingestion of any food or beverages or includes interventions that take place during surgery or that may interfere with the normal course of a patients standard care of treatment In addition the Full Health Sciences Research Ethics Board reviews any research that is above minimal risk and research where there is an unknown moderate or high physical or psychological risk for healthy volunteers or patients The Non Medical Research Ethics Board reviews all ethics applications involving human participants that include social behavioral and cultural research in a non clinical non patient based population The Delegated Health Sciences Research Ethics Board reviews all research that is deemed minimal risk or lower Full Board Health Sciences Form Non Medical Form Minimal risk research is research in which the probability and magnitude o
7. ect Sample protocol for demonstration purposes Title You will receive a confirmation email stating that your protocol has been submitted Once your protocol has been reviewed you will receive an email with Board Recommendations The Full Health Sciences REB will only accept new protocol submissions from the Pl s ROMEO account ROMEO User Guide Full Board HSREB August 2012 Post Review Once you have received the recommendations from the REB you now need to go back in to Romeo to make the changes requested by the REB to the Western Protocol Your application can be found under the heading Applications Submitted Requiring My Attention Once you have found the study in your list of studies requiring attention click the edit button and you can now revise the sections of the Western protocol form If you click on the project log button you will see that the changes you made are listed in this log Be sure to save the changes you make and save a copy of this newest version of the Western protocol form to your own computer you will need this newest version if you need to submit hard copy amendments in the future Once you have made all the required changes you need to upload any revised study documentation under the attachments tab i e revised letters of information advertisements etc These are documents that you would be editing and revising on your local computer Once you have ensured all necessary attachments
8. ences Form Attachments Logs Fig 11 1 Registration Information 2 Background Methodology and Analysis 3 Drugs and Natural Products 4 Clinical Trials 5 Risks and Benefits 6 Recruitment and Informed Consent 7 Confidentiality and Data Security 8 Conflict of Interest 9 Industry Sponsored Protocols 10 Confirmation of Responsibility Please note that important notifications have been added to the information icons above questions 2 1 2 2 2 3 2 4 2 7 and 2 9 e 2 1 Has the study undergone a formal scientific or peer review i e CIHR NSERC NIH If yes please attach the approval letter or relevant correspondence ROMEO User Guide Full Board HSREB August 2012 Attachments Tab upload all relevant study documents to the attachments tab including the letters of information sponsor protocols investigator brochures online CT registry information advertisements Health Canada FDA correspondences patient diaries etc Please ensure that all documents are in Word PDF or text format Compressed files i e ZIP files will not be accepted If you do not have an electronic copy of a required study document such as the sponsor protocol investigator brochure or product monograph please contact the ORE prior to submitting your application online Becky Ament bament uwo ca will assist in making the necessary arrangements hard copies will still be accepted Fig 12 Save Close
9. f possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research Delegated Health Sciences Form The Delegated Health Sciences Research Ethics Board reviews all research that is deemed minimal risk or lower Minimal risk research is research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research Chart Review Form ROMEO User Guide Full Board HSREB August 2012 Fig 5 Completing the Form All questions marked with a red asterisk are required Any required question that is missed will appear in the Errors tab at the far right hand side of the form You will be unable to submit the form unless all of the required fields have been completed Project Info Project Team Info Full Board Health Sciences Form Attachments l Logs Errors Full Board Health Sciences Form gt 7 Confidentiality and Data Security 7 27 Does this study require you to send data outside of the institution where it is collected This includes data taken off site for analysis Please note that Western Roabarts are considered off site locations for hospital Lawson based studies and vice versa is required Full Board Health Sciences Form gt 7 Confidentiality and Data Security 7 1
10. have been uploaded you need to click on resubmit This will lock the application again so that the modifications returned can be reviewed If the modifications submitted are correct you will then receive an automated email notice from Romeo informing you that your study has been approved You will also receive the approval notice by email and hardcopy If further changes are required you will receive an email notification from Romeo informing you that you need to logon to Romeo as additional information is required You would then follow the same procedure that you did the first time you responded to changes required Submission of Updated Approvals Step 1 Login to Romeo and select the study you need to submit an updated approval form for please remember to follow the deadline dates for these requests Step 2 On the left hand side click the events button From the list of event forms that are available select the Updated Approval form Complete the form once the form is completed hit save and then submit After the REB meeting you will receive the updated approval by email and hard copy ROMEO User Guide Full Board HSREB August 2012 PLEASE NOTE THAT CURRENTLY ONLY UPDATED APPROVALS MAY BE SUBMITTED IN ROMEO WE ANTICIPATE THAT ALL OTHER POST APPROVAL FORMS REVISIONS PROTOCOL DEVIATIONS ETC WILL BE ABLE TO BE SUBMITTED ELECTRONICALLY STARTING TUESDAY SEPTEMBER 4 2012
11. page will differ slightly for every user At anytime selecting Home on the upper right hand corner of the screen will bring you back to the ROMEO dashboard You can also update your account information by selecting My Profile Select Apply New to create a new protocol ROMEO User Guide Full Board HSREB August 2012 Powered by Process Pathways Welcome Home My Profile Contact Us Help Logout gt processpathways Owego Research Portal APPLY NEW News UsefulLinks Settings Role Principal Investigator Role Project Team Member Applications Saved Not Submitted 4 Applications Saved Not Submitted 3 Applications Submitted Under Review 1 Applications Submitted Under Review 0 Applications Submitted Requiring My Attention 0 Applications Submitted Requiring My Attention 0 Applications Submitted Post Review 1 Applications Submitted Post Review 0 Applications Withdrawn 0 Applications Withdrawn 0 My Reminders 1 My Reminders 0 Fig 4 Choosing the Correct Form Health Sciences ethics applications are reviewed at an appropriate level Delegated or Full Board based on the nature of the proposed research Please read the form descriptions provided and refer to our Categories of Review Guideline and REB Decision Tree If you still cannot determine to which REB you should submit or what type of review you require please contact one of the Ethics Offi
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