ROMEO Research Portal User Guide
Contents
1. 0 r Jon 0 0 d kK here hi bere MyPersonalSetting aspx Accessing Event Forms My Reminders From the My Reminders quick link you will see the due date of the Milestones dates in yellow font are coming due while dates in red font are past due Click on Events to access the forms My Reminders File No 6004436 Title Test January 2 2013 Test January 17 2013 APPLY NEW News Useful Links Settings Status Application Form Name T Ai Active Certification Human Ethics Application Form for Ethics Clearance new Active ge Weg Certification Human Ethics Milestones 2011 11 27 Renewal Due Send reminder 30 days before renewal dat 2013 02 08 Renewal Due Testing Event Info Tab beet gn pe po d ei Ae l 4 8 e A a el Request for annual renewal _ Ate Erus ean in he tn Ble a 0 Le Researchers and Research Coordinators are invited to Note s add comments if they wish For example if a study is being reported as closed to recruitment insert a note Completing the Event Form Complete the form by answering all the questions of the Annual Renewal Form for All Studies Interventional and Non Interventional Studies Once all of these questions have been answered click on either the Interventional or Non Interventional Studies sub tab as it applies to your study and answer the remain2. 0 2 2 If not the Pl who is the study sponsor state name of academic center investigator Industry etc i 0 2 3 Is the Pl a trainee e g student resident fellow A supervising investigator is required if the Pl is a trainee and or does not have a DHA IWK affiliation Yes A Supervising Investigator is required if the PI is a trainee and or is not a staff member with a DHA IWK appointment O No PI has a DHA IWK affiiation Attachments Tab You should attach any relevant document s as listed on the Attachments Tab Users may upload multiple attachments provided that each is no larger than 5MB Attachments may be word files spreadsheets jpeg files pdfs etc Add Attachment x Include a brief description of the document e g Mood Description Questionnaire Optional Sub P Study ICF etc If your document has a version number please list it in this box Click browse to select the i Upload Attachment Browse document from your computer Version Date HH Enter the date as it appears on your document If your document has no date leave this blank Doc Agreement Dee ER e Doc Agreement see next slide st Attachments Tab cont d Add Attachment Description Upload Attachment Version Date Doc Agreement Click add attachment to complete the process Certificate of Completion A TCPS 2 CORE Consent Form and or Addendum Current license t
3. Ala Name Name Pamela Affiliation District 9 Capital District Health Authority Adding Team Members From the Project Team Info tab scroll down to Other Project Member Info and click Add New Repeat the search process this time assigning yourself to the team and selecting your role in the study from the drop down menu under Role In Project data field You may add as many team members as required by clicking Add New Other Project Member Info Instructions Do not hand type data for this section To add more project team members to this application file click the Add New button to search for and select from other researcher profiles AOUN VJ see No records to display Do not hand type data for this section Always use Search Profiles If the person you are looking for is not in the list please contact the system administrator contact info on last page PI Role versus Project Team Member Role Once the change has been made on the Project Team Info tab the application will be accessible to the Research Coordinator and to the other team members from the Researcher s Home Page under Role Project Team Member gt Important The Pl is the only person who can submit the application once it has been completed by the Research Coordinator nova scotia a health authority APPLY NEW News UsefulLinks Settings Role Principal Investigator Ro
4. CLINICAL TRIAL Ethics Approval Submission EAS Form SE Project Status has been changed from to Active 2014 07 10 SE DEER Romeo 10 57 Project Work Flow State has been changed from Pre Submission to ORS Review Testing 2014 07 10 CLINICAL TRIAL Ethics Approval Submission EAS Form Romeo 10 45 Other Ethical Issues gt Are you aware of any other ethical issues regarding the design or conduct of the study has been changed from to No Testing CLINICAL TRIAL Ethics Approval Submission EAS Form Privacy and Confidentiality gt Will researchers personal information be transferred to parties who may store or access the information outside Canada has been changed from to No Privacy and Confidentiality gt Describe administrative physical and technical measures to be taken to safeguard the personal health information and study data has been changed from to P Privacy and Confidentiality gt Will anv personal health information PHI be collected or used to conduct the research or identity potential particioants See description for definition has been chanaed Event Forms gt Event forms are Amendments Requests for Annual Approvals Request for Acknowledgment Serious Adverse Event SAE Reporting Safety Updates and Study Completion Event Forms allow researchers to make amendments to their approved ethics application s Event Forms can be accessed completed and submitted by any membe
5. helpful tips amp hints Applications Withdrawn Click here Applications Withdrawn Click here Select the Proper Ethics Application Form EAF nova scotia health authority APPLY NEW News Useful Links Settings Ge All research projects being conducted in the Nova Scotia Health Authority NSHA and involving human participants human biological materials human embryos fetuses New Application Forms fetal tissue reproductive materials stem cells NSHA patients staff resources or data are reviewed by the NSHA REB before the research begins This applies to materials derived from living and deceased individuals Please read the descriptions below and select the appropriate ethics application form for your research submission NSHA Ethics Staff Application Name Description Status Interventional Study or Clinical Trial A clinical study in which participants are assigned to receive one or more interventions or no intervention so that researchers can evaluate the effects of the interventions on biomedical or health related outcomes The assignments are determined by the study protocol Participants may receive diagnostic therapeutic or other types of interventions clinicaltrials gov If your study meets the requirements of an interventional study as per the definition above complete this form If your study does not meet the definition of an interventional study complete the Ethics A
6. in the process you may Save and Close the application and complete it at a later date The information entered will be saved and can be accessed again through the Researcher s home page under Applications Saved Not Submitted Important Do not close that application by clicking the X at the top of your browser doing so will result in the application being locked preventing other team members from accessing it nova scotia Ai health authority APPLY NEW News Useful Links Settings Role Principal Investigator Role Project Team Member Applications Saved Not Submitted 0 Applications Saved Not Submitted 1 Applications Submitted Requiring My Attention 0 Applications Submitted Requiring My Attention 0 My Reminders 0 My Reminders 0 Applications Submitted Under Review Click here Applications Submitted Under Review Click here Applications Submitted Post Review Click here Applications Submitted Post Review Click here Applications Withdrawn Click here Applications Withdrawn Click here ROMEO has no automatic save feature But it does have a time out feature If you need to step away from your computer always hit Save and Close as a precautionary measure Failing to do so could result in information being lost or the application being locked The user responsible for locking the application is able to unlock it by acc
7. rese the Other Project Team Info section below _Change Pl Refresh Prefix Mr gt Last Name Jenkins Se ae Project Team Info tab is amiatior n MN Froiect Toon info tbs f the logged in user s information First Name Ken Rank Research Staff y Gender Institution QEII Health Sciences Centr Y lan A472 RAR Phana Dhanna QND A72 RADAR PI Role Versus Project Team Member Role At this point the applicant person completing application on behalf of the Pl will automatically be designated as PI on the application The role of the applicant from PI to Project Team Member will need to be modified to ensure the application will follow the proper process This can be done at any point during the completion of the form As long as the applicant remains PI the application will continue to be accessible from the Researcher s home page under Role Principal Investigator My Files APPLY NEW News UsefulLinks Settings Role Principal Investigator Role Project Team Member Applications Saved Not Submitted 1 Applications Saved Not Submitted 0 Applications Submitted Requiring My Attention 0 Applications Submitted Requiring My Attention 0 My Reminders 0 My Reminders 0 Applications Submitted Under Review Click bere Applications Submitted Under Review Click bere Applications Submitted Post Review Click here Applicatio
8. they may re submit the application t e em health authorit APPLY NEW News Useful Links Settings Role Principal Investigator Role Project Team Member Applications Saved Not Submitted 0 Applications Saved Not Submitted 0 Applications Submitted Requiring My Attention 0 Applications Submitted Requiring My Attention 1 My Reminders 0 My Reminders 0 Applications Submitted Under Review Click here Applications Submitted Under Review Click here Applications Submitted Post Review Click here Applications Submitted Post Review Click here Applications Withdrawn Click here Applications Withdrawn Click here Approved Applications Once the application has been approved the PI Research Coordinator and Supervising Investigator where applicable will receive an automatic email the study has been approved A formal approval letter in the form of email will also be sent The application can no longer be modified but is available for viewing under Applications Submitted Post Review nova scotia em health authority APPLY NEW News UsefulLinks Settings Role Principal Investigator Role Project Team Member Applications Saved Not Submitted 0 Applications Saved Not Submitted 0 Applications Submitted Requiring My Attention 0 Applications Submitted Requiring My Attention 0 My Reminders 0 My Reminders 0 Applications Sub
9. 0 Applications Saved Not Submitted 1 Applications Submitted Requiring My Attention 0 Applications Submitted Requiring My Attention 0 My Reminders 0 My Reminders 0 Applications Submitted Under Review Click here Applications Submitted Under Review Click here Applications Submitted Post Review Click here Applications Submitted Post Review Click here Applications Withdrawn Click here Applications Withdrawn Click here Work Flow State of Applications Under Review Check the status of your application s under review under the Work Flow State column CT Project Title Principal Investigator Application Type Status Snapshot Message IY H Y AI e H Test application CLINICAL TRIAL Ethics Approval wn 100239 Test File Romeo Testing District D Aen goe PP Project Status Active submitted for ERR ji Capital District Health Authority Se Workflow Status ORS Review review Ach Certification Human Ethics See more inside under Logs section Applications Requiring Revisions If the Board requires any revisions the application will be pushed back to the researcher applicant Pl At this stage you will be able to edit the application by clicking on this link Applications Submitted Requiring my Attention Remember that if you are making the revisions on behalf of the PI you will need to let them know when the revisions are completed so that
10. AP iii La eaitn authority Research Ethics Board esearch Portal User Guide Nova Scotia Health Authority Research Ethics Board Accessing the Researcher s Portal The Researcher s Portal is available through the Login at the following URL http mreb researchservicesoffice com Romeo Researcher Login aspx nova scotia Bi health authority Login Username Password If you are a first time user of the Researcher s Portal you must click the register button to create an account Your username should be your primary email address Once you have registered you will receive an automatic email with instructions on setting up your password Researcher s Home Page You are now in the Researcher s Home Page To access the REB application forms click on APPLY NEW nova scotia health authority i om et sm Role Principal Investigator Role Project Team Member Applications Saved Not Submitted 1 Applications Saved Not Submitted 0 Applications Submitted Requiring My Attention 0 Applications Submitted Requiring My Attention 0 My Reminders 0 My Reminders 0 Applications Submitted Under Review Click here Applications Submitted Under Review Click here Researchers should visit the Useful Links section every now Applications Submitted Post Review Click here Applications Submitted Post Review Click here amp then for
11. dment Event Info Request for Amendment Attachments Errors equest tor Amendment gt Details 0 proposed amen mentis 1 13 rave yOu attact a CODY OF your TEVIS team contact page Clearly SNOWING ali changes OY NIgniig ting OF UCI IS required Request for Amendment gt Details of proposed amendment 1 13 H hed a copy of your revise clearly showing all changes by highlighting or underlining is required The Errors tab keeps a log of any required questions that were left unanswered f all required questions were answered the Errors tab disappears Submitting the Event Form Remember that any member of the project team i e Pl Sub Investigator Research Coordinator etc is able to submit event forms by simply clicking the Submit button at the top of the form Request for Amendment Tip Please note that incomplete applications will not submit successfully the Errors tab is stil visible as in this screen shot then some of the required questions have been left unanswered and you will not be able to submit the Event Info Request for Amendment Attachments apa ion a mp i L submit button Request for Amendment gt Details of proposed amendment s 1 13 Have you attached a copy of your revised team contact page clearly showing all changes by highlighting or underlining is required Tracking the Even
12. essing it again and exiting properly All other team members who find themselves locked out of the application can either contact the user who locked it or the system administrator for support mreb notifications nshealth ca Submitting the Application gt From the moment you assign another PI and team members to the project they will be able to view and edit the application The Pl is the only person who can submit the application no other team member can do this on their behalf The team member responsible for completing the application should notify the PI when the application is ready to be reviewed and submitted gt Once the application has been submitted the PI will receive an email confirming the receipt of the application any team member associated with the application will be copied on the correspondence Applications Under Review Once the PI has submitted the application for review you will receive an email confirming the receipt of the application any team member associated with the application will be copied on the correspondence At this stage you will not be allowed to make any changes to the application However it is still available for viewing under Applications Submitted Under Review nova scotia health authority APPLY NEW News UsefulLinks Settings fan Role Principal Investigator Role Project Team Member Applications Saved Not Submitted
13. ing questions Event Info Request for Annual Renewal Attachments All Studies Interventional amp Non Interventional studies Interventional Study Non Interventional Study Complete this form for ALL studies Interventional amp Non Interventional Studies IN ADDITION to either the Interventional OR the Non Interventional request for annual renewal 1 1 What is the status of the study tick all that apply _ Enrolling participants Enrollment complete P Tip Remember that ROMEO does not have an automatic save feature E Study procedures ongoing Users are encouraged to hit the Save button after completing each _ Study has not yet started tab _ Study procedures complete _ Data analysis phase Attachments Tab Researchers are able to attach document s to the event form through the Attachments tab Users may upload multiple attachments provided that each is no larger than 5MB Attachments may be Word documents Excel spreadsheets jpeg files pdfs etc Upload Attachment bh o OX Include a brief description of the document and the date you are submitting the event form i e current date Description lachment _ Se Finn uiue AER ACTHY ad multiple attad Upload a eraf t g ul trailer YOu sty KE Attachment Click Add Attachment to complete the process Click on Browse to select the document from your computer Errors Tab Request for Amen
14. l then be able to transfer the PI role over to them Project Team Info will automatically be updated with Pl s information Transferring P I Role to Another Researcher cont d At this point you will also notice that the Submit button previously located at the top of the form has disappeared Important the next step is to add yourself to the application as a team member This must be done before you close the application Failing to do so will result in you losing access to the application form once you exit the application form Powered by Process Pathways Welcome Romeo Testing Application Ref No 1181 Project Title Application Form CLINICAL TRIAL Project Work Flow State Pre Submission Ethics Approval Submission EAS Form Save Close Print e Project Info Project Team Info CLINICAL TRIAL Ethics Approval Submission EAS Form Attachments Approvals Logs Errors Principal Investigator Instructions Do not hand type data for this section The Principal Investigator PI section default populates with the researcher profile data for the project team member who creates the file If you are not the PI click the Change PI button to search for and select an alternate researcher profile If you load an alternate researcher profile to the PI section be sure to reload your researcher profile to the Other Project Team Info section below Prefix Ms gien Trenholm
15. le Project Team Member Applications Saved Not Submitted 0 Applications Saved Not Submitted 1 Applications Submitted Requiring My Attention 0 Applications Submitted Requiring My Attention 0 My Reminders 0 My Reminders 0 Applications Submitted Under Review Click here Applications Submitted Under Review Click here Applications Submitted Post Review Click here Applications Submitted Post Review Click here Applications Withdrawn Click here Applications Withdrawn Click here Ethics Application Form EAF Interventional and Non Interventional Studies The Ethics Form s have several sub tabs all of which contain required questions If you are unsure how to answer a question try clicking on additional information may be available as seen in the screenshot below Project Info Project Team Info NON INTERVENTIONAL STUDY Ethics Approval Submission EAS Form Attachments Approvals Logs Errors Principal Investigator Attestation Administrative Information Research Protocol Information Compensation Conflict of Interest Participant Identification and Informed Consent Privacy and Confidentiality Other Ethical Issues Tip ROMEO does not have an automatic save feature Users are encouraged to hit the Save button after completing each tab Yes the PI is the study sponsor C No the PI is not the study sponsor
16. mitted Under Review Click here Applications Submitted Under Review Click here Applications Submitted Post Review Click here Applications Submitted Post Review Click here Applications Withdrawn Click here Applications Withdrawn Click here Logs Tab Workflow Logs The Logs tab is a useful tool that shows the history of the application Text in blue font represents most recent updates The Workflow Logs tracks and time stamps approvals and messages Powered by Process Pathways Welcome Romeo Testing File No 100239 Project Title Test File Project Work Flow State ORS Review Application Form CLINICAL TRIAL Ethics Approval Submission EAS Form Project Info Project Team Info CLINICAL TRIAL Ethics Approval Submission EAS Form Attachments Approvals Logs Workflow Log Project Log amp Activity Log Workflow State Workflow Message User Role Group lew Fi omitted By Researcne 10 07 2014 New File Submitted By Researcher Project Work Flaw State has been change from Pre Submission to ORS Pre Submission gt ORS Test application being submitted for review Action Romeo Principal 10 52 Review Review Submit Testing Investigator Logs Tab Project Logs gt The Project Logs tracks and time stamps every action taken on the application File No 100239 Project Title Test Fle Project Work Flow State ORS Review Application Form
17. ns Submitted Post Review Click here Applications Withdrawn Click bere Applications Withdrawn Click bere Project Team Info Tab gt Project Team Info tab is automatically filled out with applicant s info To change the role of PI over to another researcher click on Change PI Important DO NOT change Pl s Last Name and First Name manually always use Change PI feature Application Ref No 1181 Application Form CLINICAL TRIAL Ethics Approval Submission EAS Form Project Info Project Team Info CLINICAL TRIAL Ethics Approval Submission EAS Form Attachments Approvals Logs Errors Principal Investigator Instructions Do not hand type data for this section The Principal Investigator PI section default populates with the researcher profile data for the project team member who creates the file If you are not the PI click the Change PI button to search for and select an alternate researcher profile If you load an alternate researcher profile to the PI section be sure to reload your researcher profile to the Other Project Team Info section below onan si Prefix X Last Name Testing First Name Romeo Affiliation District 9 Capital District Health Authority z Rank z Gender Unspecified v Institution QEII Health Sciences Centre Transferring PI Role to Another Researcher Once you click Change PI you can search the Investigator Lis
18. o practice in NS Curriculum Vitae CV Data Collection Tool Health Canada Letter of Authorization No Errors Tab Project Info Project Team Info Project Info gt Project Title is required NON INTERVENTIONAL STUDY Ethics Application Form EAF gt Administrative Information 2 1 Is this a locally initiated investigator driven research study e g the PI is the stud required NON INTERVENTIONAL STUDY Ethics Application Form EAF gt Administrative Information 2 3 Is the PI a trainee e g student resident fellow A supervising investigator is re PI is a trainee and or does not have a DHA IWK affiliation is required NON INTERVENTIONAL STUDY Ethics Application Form EAF gt Administrative Information 2 4 Has funding been obtained for this study is required NON INTERVENTIONAL STUDY Ethics Application Form EAF gt Administrative Information 2 7 What does this study involve select all that apply is required NON INTERVENTIONAL STUDY Ethics Application Form EAF gt Administrative Information 2 8 Has this study been reviewed by a committee department or division of a partici institution is required NON INTERVENTIONAL STUDY Ethics Application Form EAF gt Administrative Information 2 9 Has this study been reviewed externally e g by funding agencies or other acader institutions organizations is required Save and Continue At any point
19. or an annual approval renewal request you can access the event forms by clicking on Events y Fies APPLYNEW News UsefulLinks Setings Principal Investigator Application Type Status Snapshot Al 7 i Y CLINICAL TRIAL Ethics Approval Project Status Pending Submission EAS Form Workflow Status Pre Submission Certification Human Ethics Last Saved 2014 07 14 Romeo Testing District 9 Capital District Health Authority Ref No 1184 Accessing Event Forms APPLY NEW News Useful Links Settings File No 6007658 Title Test January 17 2013 New Event Forms Study Closure select the form you need to Request for Annual Renewal submit by clicking on the hyperlinks under New Event Forms Requesl for Armmendineril Request for Acknowledgement Safety related events reporting PSUR DSMB Safet Major Study Violation Local Serious Unexpected Adverse Reaction Reportin My Reminders My Expired Reminders My Events Form Category Status SubmissionDate T T T T View Event New Approval Process Active 2013 01 4 Setting Reminders gt To receive reminders e g annual approval due in 30 days click on Settings Tick the box to receive reminders and then click save Y NEW News Useful Links would like to receive notifications regarding due expired dates reminders A e g Progress Report Reminder Certification Expiration Reminder
20. pplication Form for Non Interventional Studies Complete this form if your study is NOT a clinical trial If your study is a clinical trial complete the clinical trials INTERVENTIONAL STUDY Ethics Application Form EAF NON INTERVENTIONAL STUDY Ethics Application Form EAF EAF form Project Info Tab Powered by Process Pathways Welcome Romeo Testing Application Ref No 1177 Application Form NON INTERVENTIONAL STUDY Ethics Approval Submission EAS Form Title S Enter your study title exactly as it appears on your research protocol Note The amp end dates are used for administrate and reporting purposes wil be entered by the MREB office staff Start Date D Wi IMPORTANT Please note that all End Date A fields preceded by are required E Failing to complete these fields will Aad prevent the user from submitting the form Project Team Info Tab Attachments Approvals NON INTERVENTIONAL STUDY Ethics Application Form EAF Project Info 4 Project Team Info l Principal Investigator Instructions Do not hand type data for this section The Principal Investigator PI section default populates with the researcher profile data for the project team member who creates are not the PI click the Change PI button to search for and select an alternate researcher profile If you load an alternate researcher profile to the PI section be sure to reload your
21. r of the project team i e the PI Sub investigator s Research Coordinator etc as opposed to the original ethics application which can only be submitted and re submitted by the PI Accessing Event Forms You can access Event Forms at any time either under Role Project Team Member by clicking on Applications Submitted Post Review Applications will also be available within 30 days of the ethics renewal due date by clicking on My Reminders nova scotia health authority APPLY NEW News UsefulLinks Settings nr Role Principal Investigator Role Project Team Member Applications Saved Not Submitted 0 Applications Saved Not Submitted 0 Applications Submitted Requiring My Attention 0 Applications Submitted Requiring My Attention 0 My Reminders 0 My Reminders 0 Applications Submitted Under Review Click here Applications Submitted Under Review Click here Applications Submitted Post Review Click here Applications Withdrawn Click here Applications Withdrawn Click here My Reminders Application available 30 days before the annual approval renewal form is due Accessing Event Forms Applications Submitted Post Review gt By clicking on Applications Submitted Post Review you may view all of your approved ethics applications From there if you wish to submit an amendment form a serious adverse event SAE
22. s been assigned for review the Status of the application will change from Submitted by Researcher to Pending My Reminders Annua Renewal Form Renewal Due 201 5 02 8 M A Renewal My Expired Reminders My Events Form SuomissionDate ka Le Le E Annual Renewal Form Renewal Pending 2013 01 25 Event Form Approval Once the event form has been reviewed and approved the status of the event will change from Pending to Active The PI Research Coordinator and the Supervising Investigator if applicable will receive a confirmation email along with a copy of the formal approval letter This letter has also been attached to the original application and can be viewed through the Attachments tab by any project team member Please Note The process for submitting any type of Event Form is the same as what has been described here My Events Status SubmissionDate i i i i View Event Annual Renewal Form Renews Need assistance have a question Contact your system administrator o 902 473 2126 gt mreb notifications nshealth ca regs hauth La ealth authority
23. t Form The Pl and other members of the project team will not receive a confirmation email after submitting an event form gt However they can still track whether or not their form was submitted by accessing the application for which you submitted an event form either through Applications Submitted Post Review or My Reminders and clicking on Events Event forms that were started and saved but not submitted will appear under My Saved Events My Reminders Milestone Due Date Comments Sponsor Event Related Forms Annua Rerewa Form via NW My Expired Reminders Tip As long as the event form has not been submitted you will be able to edit it If you can see the Edit Event button you have not submitted the form yet Rets Comments Category Form Renewa HSREB Annua Renewal Form for Approved Studies Tracking the Event Form cont d Once the event form has been submitted it will move down to My Events You will be able to view the event but will no longer be able to edit it My Reminders Annual Renewal Form Serewal Due 2013 02 8 ALA Renewal My Expired Reminders Note that the Status of the application indicates Submitted by Researcher Form Category Status SubmissionDate D D Y Annual Renewal Form Renewal 2013 01 25 Tracking the Event Form cont d gt Once the event form ha
24. t for the name of the person to be assigned as Pl The list can be searched in a variety of ways i e type the last name of the person in the Last Name field or use the filter to select search criteria such as Start With or Any part Investigator List Instructions Search for and select the researcher profile you want to load to this application fle If the project team member our system administrator for does not have a researcher profile contact Start With Any part Researcher X Y T Transferring PI Role to Another Researcher gt Once you ve identified your PI click on select ES Investigtor List k O x Instructions Search for and select the researcher profile you want to load to this application file If the project team member does not have a researcher profile contact your system administrator for guidance Start With Any part Last Name MackKnight First Name Options Last Name First Name Primary Affiliation W W La MacKnight Chris If you are unable to identify the person you are looking for from the investigators list please email the system administrator mreb notifications nshealth ca Your email should include the person s full name title business address office phone number and email address You will be notified as soon as the person has been added to the investigators list and wil
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