research management system - cheo research institute manual v3_4jan2019.pdf · romeo research...

ROMEO

Research Management System

Guide for Investigators and Research Staff

REB File

Management

Internal Award

Applications

Contract

Requests

External Award

Registrations

Table of Contents

Table of Contents ................................................................................................................................. i Where do I find more information? ..................................................................................................... 1

ROMEO: ............................................................................................................................................ 1

ROMEO Resources: ....................................................................................................................... 1

ROMEO Support: ............................................................................................................................ 1

Awards: .............................................................................................................................................. 1

Awards Website: ............................................................................................................................. 1

Awards Office: ................................................................................................................................ 1

Contracts: ........................................................................................................................................... 1

Contracts Website: ......................................................................................................................... 1

Contracts Office: ............................................................................................................................. 1

Finance & Cost Centres ..................................................................................................................... 2

Finance Website ............................................................................................................................. 2

Finance Office ................................................................................................................................ 2

REB Queries: ..................................................................................................................................... 2

REB Website: ................................................................................................................................. 2

REB Office: ..................................................................................................................................... 2

CRU Resources: ............................................................................................................................. 2

ROMEO Research Management System Overview ........................................................................... 3

General Information............................................................................................................................ 3

System overview ................................................................................................................................ 3

System Functionality .......................................................................................................................... 4

Navigating this manual ....................................................................................................................... 5

Navigating ROMEO .............................................................................................................................. 6

Logging in .......................................................................................................................................... 6

Navigating the Home Page................................................................................................................. 7

Finding your Projects – Organizational categories .......................................................................... 7

Finding your Projects – Ethics Review Flowchart ............................................................................ 8

Finding your Projects – Awards Review Flowchart .......................................................................... 9

Search Bar.................................................................................................................................... 10

Navigation Bar .............................................................................................................................. 10

Profile ........................................................................................................................................... 11

Navigating Within a Project – New Application ................................................................................. 12

Project Info ................................................................................................................................... 13

ii

Project Team Info ......................................................................................................................... 15

Project Sponsor Info ..................................................................................................................... 16

Attachments .................................................................................................................................. 20

Approvals ..................................................................................................................................... 22

Logs.............................................................................................................................................. 22

Errors ............................................................................................................................................ 23

Submitting your Application .......................................................................................................... 24

Applying for Ethics ............................................................................................................................ 25

Mandatory Training .......................................................................................................................... 25

Types of REB submissions............................................................................................................... 25

Prescribed Entity or Prescribed Registry ....................................................................................... 26

Prospective Studies Involving Minimal Risk .................................................................................. 29

Retrospective Chart Review or Secondary Analyses of Clinical Samples ..................................... 32

Full Board Review ......................................................................................................................... 34

Ontario Cancer Research Ethics Board (OCREB) Administrative Application ............................... 39

Clinical Trials Ontario (CTO) Administrative Application ................................................................ 42

Investigational Device Project ....................................................................................................... 44

Applying for Awards or a Contract ................................................................................................... 47

Types of Internal Funding Submissions ............................................................................................ 47

CHAMO Innovation Grant (AHSC AFP Innovation Fund) .............................................................. 47

CHEO RI ICES Research Grant ................................................................................................... 48

Research Growth Award (RGA) .................................................................................................... 49

Quality Improvement Grant (QIG) ................................................................................................. 50

Resident Research Grant Application ........................................................................................... 51

Summer Studentship Application .................................................................................................. 52

Types of External Funding Submissions ........................................................................................... 53

Research Registration Form ......................................................................................................... 53

Contract Submissions ...................................................................................................................... 54

Contract Submission Process ....................................................................................................... 54

No Study or Funding Associated – Research Registration Form ................................................... 55

Funded study ................................................................................................................................ 55

Returned Applications ....................................................................................................................... 56

Navigating Within a Project - Events ................................................................................................ 58

Ethics Events ..................................................................................................................................... 60

Responding to REB Feedback ......................................................................................................... 61

Investigator Response to REB Feedback ..................................................................................... 61

iii

Ethics Events to Make Changes to your Study ................................................................................. 62

Continuing Review Form – Major Modification .............................................................................. 62

Continuing Review Form – Minor Modification for Delegated Review ........................................... 64

Minor Administrative or Editorial Changes Form ........................................................................... 65

Translated Study Documents ........................................................................................................ 65

Ethics Events to Notify the REB of Issues or to Submit Reports ....................................................... 66

Continuing Review Form – Serious Adverse Events (SAEs) ......................................................... 66

Continuing Review Form – Protocol Deviation .............................................................................. 66

Acknowledgement form ................................................................................................................ 67

Annual Renewal Events ................................................................................................................... 68

Continuing Review Form – Annual Renewal for Delegated Review .............................................. 69

Continuing Review Form – Annual Renewal for Full Board Review .............................................. 71

Continuing Review Form – Annual Renewal for Prospective Chart Reviews ................................. 75

Prescribed Entity or Registry Annual Renewal Form ..................................................................... 77

Awards and Contracts Events .......................................................................................................... 78

Types of Awards Events ................................................................................................................... 78

Capacity Building Report .............................................................................................................. 78

Project Status Change Form ......................................................................................................... 79

Research Growth Award Report (Formerly the Feasibility / Start Up Grant Report) ...................... 80

Types of Contracts Events ............................................................................................................... 82

Arc Outbound MTA ....................................................................................................................... 82

Contract / Agreement Submission Form ....................................................................................... 83

Returned Events ................................................................................................................................ 86

Closing your Study ............................................................................................................................ 88

Ethics Closure .................................................................................................................................. 88

Ethics Study Closure Definitions ................................................................................................... 88

Continuing Review – Change in Study Status (NEW FORM added June 27, 2016) ...................... 89

Continuing Review Form – Study Closure .................................................................................... 90

Continuing Review Form – Study Closure Retrospective Chart Review ........................................ 91

Awards Closure ................................................................................................................................ 92

Project Status Change Form ......................................................................................................... 92

Contract Closure .............................................................................................................................. 93

Closing your study? Have you considered… .................................................................................... 93

Notifying the Communications department.................................................................................... 93

Accessing Quality Assurance Resources ...................................................................................... 93

Need to go back? Click Alt and on your keyboard 1

Where do I find more information?

ROMEO: ROMEO Resources: ROMEO Video resources ROMEO Short-form manuals

ROMEO Support: [email protected] Beth Gillis SuperUser (ext. 4165) Laura Minaker-Roy SuperUser (ext. 2694)

Awards: Awards Website: Internal Funding Opportunities External Funding Opportunities Grant Tips and Resources

Awards Office: Jenna Pepper, Grants & Contracts Assistant Scope: ROMEO Support

Contracts: Contracts Website: Contracts Information Sheet

Contracts Office: Jenna Pepper, Grants & Contracts Assistant First point of contact

Administrative Queries Document execution

Prudence Tsui, Contracts Officer Scope: Legal Review Karen Wilkes, Senior Contracts Officer Scope: Legal Review

Document approval

http://www.cheori.org/en/romeovideos

http://www.cheori.org/en/Romeohandbook

mailto:[email protected]

https://cheonet.cheo.on.ca/research-learning/research-institute/grants-pre-awards/internal-funding-opportunities

https://cheonet.cheo.on.ca/research-learning/research-institute/grants-pre-awards/external-funding-opportunitites

https://cheonet.cheo.on.ca/research-learning/research-institute/grants-pre-awards/grant-tips-and-resources


https://cheonet.cheo.on.ca/research-learning/research-institute/cheo-ri-contracts





Finance & Cost Centres Finance Website Finance forms

Finance Office Reference the investigator list on CHEOnet to determine your designated Research Finance Officer. Laura Minaker-Roy, Senior Research Finance Officer (ext. 2694) Beth Gillis, Research Finance Officer (ext. 4165)

REB Queries: REB Website: Document templates Directions for initial submission Directions for continuing reviews

REB Office: Natalie Anderson, Senior Coordinator, Research Ethics Board Scope: Annual Renewals

Delegated Reviews Valerie Bourada, Manager, Research Ethics Board Scope: Delegated Reviews

Review Process

CRU Resources: Chantal Horth, Ethics Facilitator Scope: Consult with researchers to ensure high quality REB submissions

Advise junior researchers and coordinators during the REB process Key element review of REB Submission Note the REB Facilitator is independent of the REB. They will not provide advice on ethical content of submissions.

Click Here to request a consult.

https://cheonet.cheo.on.ca/research-learning/research-institute/cheo-ri-finance-and-post-awards

https://cheonet.cheo.on.ca/research-learning/research-institute/cheo-ri-finance-and-post-awards



http://www.cheori.org/en/templates

http://www.cheori.org/en/rebreviews

http://www.cheori.org/en/rebcontinuingreviews



http://www.cheori.org/en/clinicalresearchunit


ROMEO Research Management System Overview

General Information The ROMEO Research Management System is a web-based system that allows you to apply for and manage your grant applications, contracts, and Research Ethics Board files.

System overview The ROMEO Research Management System has two components –Awards (grant application, grant registration, contract submission, and contract execution) and Certifications (Research Ethics Board applications, renewals, and notifications). These components are distinct from each other, and for this reason most projects have to be entered twice to both register the funding and to apply for ethics approval. When navigating the system, it is important to consider the set-up as two distinct entities. Submissions in ROMEO, whether Awards or Certification, are divided into two categories, Applications and Events. Applications are to create a new file, with the intention to either apply for a new internal funding competition, register a new project, or apply for new REB approval. Events are used to add information to an existing project, whether it is to submit a contract to a registered grant or to renew REB approval.


System Functionality There are certain features unique to ROMEO, which are as follows:

• Your browser’s Back button is disabled when navigating the ROMEO interface. Please click Home or Back Home to return to the home page

• Be sure to click Save repeatedly as you move through the various tabs of your application, as

there is no auto-save feature

• You are able to export any application either before or after submitting. For best functionality, export the document to Word and save with your files.

• Before you exit the file, Save and Close to ensure the project does not get locked.

• Any fields marked with a red asterisk are mandatory. Any unmarked are optional but should be completed if they apply to your submission.


Navigating this manual This manual includes a break-down of applications and events within CHEO’s ROMEO system, and is intended to be viewed electronically. It includes hyperlinks to navigate to the section which is most applicable to you, links to videos which provide step-by-step walkthroughs, and contact information if you have further questions. Note the hyperlinks may be tied to CHEOnet, so for optimal use of this manual please log in through Citrix. If at any point you click a hyperlink which takes you to a different section of the manual and you wish to go back, click Alt and on your keyboard. This will take you back to the page on which you clicked the hyperlink. General information applicable to all applications can be found under Navigating ROMEO. This includes how to set up an account, an overview of the home page and tabs, and tips to help you track your studies. Once familiar with the general lay-out, you are ready to apply for REB approval, internal funding, or to register an externally funded or unfunded study (this will allow you to submit a contract or open a cost centre). If you are using this manual electronically, How-To Videos are linked throughout the document. To review the full collection of ROMEO videos, visit (URL)


Navigating ROMEO

Logging in Managers should include ROMEO when completing the Access Control Form. To obtain a username and password, contact the ROMEO SuperUsers. Once added to your Citrix account, ROMEO can be accessed when connected to Citrix by opening the Web Links folder. Note preferred browsers are Edge, Chrome, or Firefox.

If you are connecting from outside the CHEO server, ROMEO is available on the internet through https://cheo.researchservicesoffice.com/ROMEO.Researcher/Login.aspx. If you are frequently logging in off site, it is recommended you bookmark this link in your browser for easy access.

https://cheonet.cheo.on.ca/central-services/information-services/forms


https://cheo.researchservicesoffice.com/ROMEO.Researcher/Login.aspx


Navigating the Home Page Once logged in, you will see up to three roles – Principal Investigator, Project Team Member, and / or Reviewer. Note Other Signing Authority will not be visible on your home page as this function is not used at CHEO. Your files will be organized based on your role in each individual study. If you are listed as the Principal Investigator on a project, you will find your documents for this project under the Principal Investigator tab. If you are listed as any other Project Team Member (Co-Investigator, Research Coordinator, Administrative staff), you will find the documents for this project under the Project Team Member tab. If you are selected to be a reviewer for either an REB file or a grant application, the relevant documents can be found under the Reviewer role. For instructions specific to the Reviewer role, please refer to the Reviewer manual.

Finding your Projects – Organizational categories On the home screen, there are five locations where your projects could be stored in each of the role blocks. These categories are standard across the Principal Investigator and Project Team Member roles. For instructions specific to the Reviewer Role, click here.

Applications: Drafts – Incomplete ethics or grants applications that have not been submitted Applications: Requiring Attention – Submitted applications that have been returned as there is an error or they are incomplete Applications: Under Review – Applications not yet accepted for review by the REB or Awards office. Applications: Post-Review – Applications accepted for review by the REB or Awards office or those who have been approved. Applications: Withdrawn – Applications the investigator has withdrawn from evaluation.

In addition, there are three event-specific categories which provide a quick link to the already submitted project and the specific event in question. Events: Drafts – Projects with incomplete event forms not yet submitted for review. Events: Requiring Attention – Projects with event forms returned to the research team as they are incomplete or erroneous. Reminders – Quick reference to REB projects with upcoming annual renewals or to funding applications requiring reporting.


Finding your Projects – Ethics Review Flowchart A

pplic

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Dra

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App

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: U

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Rev

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App

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: R

equi

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Atte

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App

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: Po

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Research team creates application

Application returned to be

completed

Submit

No

Yes

Accepted for review?

Reviewed by REB (delegate /

full board)

Feedback?

Submit response as an event in the application

Application approved

No

Yes

Re-submit


Finding your Projects – Awards Review Flowchart A

pplic

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Dra

ft

App

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: U

nder

Rev

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App

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: R

equi

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Atte

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App

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: Po

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Research team creates application


completed

Submit

No

Yes

Accepted for review?

Reviewed by Awards Office

File returned to research team to create Part 2

Application for Registration

approved (External Funding / Unfunded)

No

Yes

Re-submit

Invited to Part 2?

Two-part application?

No Accepted for review?

Reviewed by Awards

Office


completed

Funded?

Application approved & not funded (internal)

Application approved & funded

(internal)

N/A

No

No

Yes

Funded? No

Yes

Yes


Search Bar You are able to search for your ROMEO file or event using its File number, Reference number, Event number, or Event Reference numbers. This will bring you directly to the file or event in question.

File No –Submitted application Application Ref No – Draft applications Event No – Submitted Event Event Ref No – Draft Event

Navigation Bar The Apply New button will allow you to begin a new internal grant or REB application and to register studies that have external funding or are unfunded. News will provide information on upcoming RI events, new publications from fellow RI investigators, and other RI information. Useful Links provides commonly used resources, including the ROMEO manual, regulatory references, and CHEO Policies.


Profile Your personal profile is available through My Profile.

Once you have entered your profile, changes can be made to the following areas:

Any changes made to your first name, last name, email, or affiliations must be done by the ROMEO Administrator.




Navigating Within a Project – New Application There are seven main tabs within any REB, grant, or research registration application. There are five standard, a sixth included only in the awards applications, and a seventh containing custom questions specific to your application. For details on how to complete the custom questions for your specific applications, return to the Table of Contents and select the appropriate new application. Please complete all information in the tabs prior to submitting the application.

0


Project Info

Full title of your study

Individually select any relevant key words using the dropdown menu, then click Add. To clear, click Clear all

Related awards or certifications in ROMEO are linked using Search

Click [Select] to identify the linked awards file


When selected, the information will populate in Related Awards

If you are creating an awards file, follow the same steps to link the ethics certification


Project Team Info

The Project Team Info tab captures key project team data, such as the Principal Investigator (“PI”), team affiliations and contact information. For REB applications, the Principal Investigator must be a CHEO affiliated researcher; Fellows, Residents, and Students must be added as Other Project Members on the application even if it is their project. For Funding applications, residents and fellows may be listed as PI. CHEO-affiliated investigators and RI staff (coordinators, research assistants) must be listed on this file. If you are hiring new staff (paid or unpaid) to assist with this project, review the Research Institute Human Resources (RI HR) Department’s Step by Step Guide on Hiring / Extending a Research Employee or contact the RI HR department.

You will be brought to the investigator list when changing the PI or adding new team members

Type any part of the last or first name into the text box and select Search

If you are submitting on behalf of another individual, you must change the PI.

When you find the correct investigator, click Select. If the individual has not yet been added to the system, email the ROMEO Administrator.

To add additional team members or to add yourself back onto the project, click Add New

In order to maintain access to the file once you change the PI, you must add yourself back on as an Other Project Member. Be sure to select your appropriate role when adding yourself back on to the project.

https://cheonet.cheo.on.ca/research-learning/research-institute/human-resources/step-step-guide-hiringextending-research-employee

https://cheonet.cheo.on.ca/research-learning/research-institute/human-resources/step-step-guide-hiringextending-research-employee




Project Sponsor Info

This tab is only found in Awards applications. It allows you to identify your project’s funding and how it will be dispersed through the project’s timeline. Only complete this tab if you are registering funds from an external source.

Click Agency to view the agency names. You must do this prior to selecting the program.

Note if CHEO is a site for a multi-centre study, please list the funder and not the lead site unless the funding source is an internal grant from the lead site. If the funding agency is not listed, please contact the ROMEO Administrator.



You may now select the appropriate program by clicking the arrow.


Click Add New to include funding disbursement across fiscal years.


Information is recorded based on each fiscal year of the grant. Populate information for first fiscal year and information on requested funds. Note the fiscal year ends March 31st.

Information on funds awarded will be entered by the finance department when the cost centre is opened.

Click Save once the information for this fiscal year has been entered.

Continue adding disbursement to account for all research funds across the applicable fiscal years. Once complete, click Save


Attachments All documents pertinent to your submission must be appended in the Attachments tab. This includes any items in the application check-lists (if applicable), any documents referenced in the application and any documents referenced in the attachments. Please ensure, at minimum, all submissions have a protocol attached.

The attachments tab will provide a list of documents that should be attached to your application, as well as any pertinent instructions or links to guidelines.

Any document templates associated with the specific application, including Signature Pages will be found at the bottom of the attachments page.

To begin adding an attachment, click Add Attachment.


Study Name_Document type_Version_Version Date

Click to view the calendar or free-type YYYY/MM/DD. This date should be the date the document was finalized, not the date of submission.

Browse will allow you to find the document in your folders.

Click the arrow to select the document type. If none are applicable click Other Click Add Attachment to finish attaching

the document.

All attached documents will be listed at the bottom of the attachment page. Click Edit to change the Doc/Agreement type, version date, or description.


Approvals

The Approvals tab is not used by CHEO and can be ignored.

Logs

This page is divided into three sections: Application Workflow Log, Application Log, and Shared Communication

The Application Workflow Log outlines any changes in file workflow. Prior to submission this will remain blank. The workflow message is where any information typed in the Comments box will appear.

The Application Log outlines any changes made to the file content.

Shared Communications houses all emails sent to the research team through ROMEO. Click the magnifying glass to view or reprint the emails.


Errors

This is where you are notified of any required fields that have been left incomplete. Within this tab it will inform you of the location and questions that is incomplete. The tab will disappear once all of the fields are complete and you are ready to submit.


Submitting your Application Once you have reviewed the content of your application and the Errors tab is no longer visible, you are ready to submit! Only the PI will be able to submit an initial application. If you are the PI and do not see the Submit button, please verify that you are appropriately listed in the Project Team Info tab.

A comment box will appear when you click Submit. Any information typed in this section will appear in the Workflow Message section of the Application Workflow Log. Type in your comment and click Submit. If you do not wish to add a comment, type any key and click Submit.

Now that you have completed all of the standard tabs, return to the Table of Contents to select the appropriate new application. This will provide a detailed overview of requirements specific to your application. You can also browse all of the Ethics, Awards, and Contracts submission options.


Applying for Ethics

The REB oversees all human research conducted at or through the hospital. The REB defines research as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. Data collected are used to answer a specific question. This is distinct from quality assurance activities that are intended to assess the performance of an organization or its staff, within the mandate of the organization. In quality assurance, the data are used to advance the needs and functioning of the organization. Although the REB does not review case studies, clinical case series may fall under the jurisdiction of the Board. Please consult the REB to determine if your study requires REB approval. Please visit the REB website for ROMEO form updates and important submission information.

Mandatory Training All members of the project team affiliated with or employed by CHEO must have the appropriate training for the submission type, as defined by:

TCPS GCP Division 5

All study submissions to REB

Study submissions for non-regulated trials

Study submissions for Phase I-IV or natural health product regulated clinical trials

All training can be accessed through CITI-Canada Online Training. Once training is completed, certificates are added to a database that is managed by the Quality Assurance Department at the CHEO RI. Some certificates may need to be provided upon request of the REB, but only one time (i.e. for new staff or when training is completed while affiliated with an institution other than CHEO). Be sure to add CHEO to your affiliated institutes in your CITI Canada Online Training account. For additional information on mandatory training, visit the REB website.

Types of REB submissions


http://www.cheori.org/en/ROMEOformupdates

https://www.citiprogram.org/index.cfm

http://www.cheori.org/en/mandatorytraining


Prescribed Entity or Prescribed Registry This application is intended for studies using data from either a Prescribed Entity or Registry, including the BORN database. Such studies require approval from the registry or entity prior to REB submission. Please contact the Entity or Registry directly for details on their approval process. Below will outline how to complete the Prescribed Entity or Prescribed Registry Application tab. For information on how to complete the standard application tabs, click here.

Only identify the registry you have applied to access. Although registries / entities access information from each other, only the one with which you have applied to will be identified.

Conflict of interest declarations apply to any CHEO staff or CHEO-affiliated investigator.


If you are transferring data to or from the Prescribed Entity or Registry, you will require a Data Sharing Agreement. Click here information on submitting to the contracts office.

Generally the data retention period for non-regulated studies is 7 years after study closure and for Health Canada Division 5 regulated studies is 25 years after study closure. Visit the REB website for further details.

General safeguards for the storage of research data can be found on the REB website.

All study documents must include a version date and version number which will be located in the document footer. Visit the REB website for document templates.

http://www.cheori.org/en/rebretentionofstudyrecords

http://www.cheori.org/en/rebprivacyconfidentiality



Note: If you cannot see the Submit button, you are likely not listed as the PI. Visit the Project Team Info tab to review the PI information. Click here for more details on how to change the PI.


Prospective Studies Involving Minimal Risk Below will outline how to complete the Prospective Studies Involving Minimal Risk tab. This application is to be completed for any prospective study involving risk no greater than what would normally be encountered in everyday life by the research subject. This may include surveys, Quality of Life questionnaires, or non-invasive procedures. For information on how to complete the standard application tabs, click here.


The population groups are not limited to CHEO (i.e. may include Community Hospitals, schools etc.)

Click here for more information on review fees. Any unfunded or solely investigator funded study is exempt from these fees.

http://www.cheori.org/en/REBreviewfees


Click here information on submitting to the contracts office.

This information may be copied from your protocol. Please be sure to review for lay readability. Visit the REB website for protocol templates.

This information may be copied from your protocol. Please reference SOP 009_06 for information on Subject Recruitment and Screening.

Deception or partial disclosure occurs in studies where the participant does not know the purpose of the study in advance. In order to be approved, such studies must fall within the exception to the general requirements of full disclosure for consent (TCPS, Article 3.7A).


http://www.cheori.org/en/templates?id=0

https://cheonet.cheo.on.ca/research-learning/research-institute/clinical-research-unit/quality-assurance-and-education/standard-operating-procedures-sops


http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter3-chapitre3/





Data Sharing Agreements may be required for data transfer. Click here for contract submission information

Generally the data retention period for non-regulated studies is 7 years after study closure. Visit the REB website for further details.




Retrospective Chart Review or Secondary Analyses of Clinical Samples Below will outline how to complete the Retrospective Chart Review or Secondary Analyses of Clinical Samples Application tab. Additional information on the secondary analysis of clinical data can be found on the REB website. For information on how to complete the standard application tabs, click here.



Click here for more information on review fees. Any unfunded or solely investigator funded study is exempt from these fees.

This synopsis can be copied and pasted from sections of your protocol. For protocol templates, click here.

http://www.cheori.org/en/rebsecondaryanalysisdlinicaldatasamples






Data Sharing Agreements may be required for data transfer. Click here for contract submission information

Generally the data retention period for non-regulated studies is 7 years after study closure. Visit the REB website for further details.






Full Board Review Below will outline how to complete the Full Board Review tab. Studies submitted for Full Board review are classed as greater than minimal risk. These applications include but are not limited to drug, natural health product, or device trials. Non-interventional studies are also reviewed by the Full Board. Please consult the REB office if you are unsure which application to submit. Full Board applications must be submitted as per the submission deadline schedule in order to be reviewed by the full board at the next meeting. There are many considerations when submitting a study for Full Board review. Please carefully read the application guidelines for information pertinent to your study. For information on how to complete the standard application tabs, click here. Due to the strictly regulated nature of most Full Board studies, adherence of the Quality Assurance templates, guidelines, and SOPs are required. Contact the Research Institute Quality Assurance Program for clarification and assistance with any regulatory documents, or if you require assistance with regulated trial start-up, monitoring, or compliance.


Click here for more information on REB review fees. Any unfunded or solely investigator funded study is exempt from these fees.

Please reference SOP 412.001, CHEO REB Independent Peer Review Policy, for further details.

http://www.cheori.org/en/rebmeetings

http://www.cheori.org/en/rebapplicationsguidelines

https://cheonet.cheo.on.ca/research-learning/research-institute/clinical-research-unit/tools-and-templates

https://cheonet.cheo.on.ca/research-learning/research-institute/clinical-research-unit/quality-assurance-and-education/guidelines-and-regulations





http://www.cheori.org/en/REBstandardoperatingprocedures



Clinical Drug Trial phases can be found here under subheading – Classification of Clinical Trials.

A CTA must be submitted to Health Canada for all Phase I, II, and III clinical drug trials. Contact CHEO RI's Quality Assurance Program for further information.

Clinical Trial phases for NHPs are defined similarly as for Clinical Drug Trials. The phase definitions can be found here under subheading – Classification of Clinical Trials.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_background-eng.php




A CTA must be submitted to Health Canada for all Phase I, II, and III NHP Clinical Trials. Contact the CHEO RI Quality Assurance Program for further information.

Contact the CHEO RI Quality Assurance Program for guidance prior to submitting a device trial.

Click here for information on registering your study.





https://cheonet.cheo.on.ca/research-learning/research-institute/clinical-research-unit/clinical-trial-registration







All investigator-sponsored studies initiated at CHEO will be monitored by the CHEO Quality Assurance Program. Further, all studies (industry and investigator sponsored) must submit a monitoring plan to the REB as a part of the initial application. Please see SOP 901.002 for additional information.





Ontario Cancer Research Ethics Board (OCREB) Administrative Application Below will outline how to complete the Ontario Cancer Research Ethics Board (OCREB) Administrative Application tab. This application is intended for studies submitted to and approved by OCREB using CTO Stream. Although the study has ethics approval through OCREB, administrative approval is required through ROMEO prior to study start-up. For information on how to complete the standard application tabs, click here.

Information on medical device classification can be found here.


Clinical Drug Trial phases can be found here under subheading – Classification of Clinical Trials.



https://oicr.on.ca/research-portfolio/ocreb/investigators-research-teams/

http://laws.justice.gc.ca/eng/regulations/SOR-98-282/page-3.html#h-10





All CHEO-specific study documents submitted to OCREB must include a version date and version number which will be located in the document footer. Visit OCREB and CHEO's REB for document templates.



Leaders from all impacted departments are required to sign the signature page

https://ocrebonline.ca/prod_eREB/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5bOID%5b1EA9545BED4F0C4BB0310F439ACAF2D4%5d%5d





Clinical Trials Ontario (CTO) Administrative Application Below will outline how to complete the Clinical trials Ontario (CTO) Administrative Application tab. This application is intended for studies submitted to and approved by a CTO Qualified Board of Record using CTO Stream. Applicants should complete this form in ROMEO once the Provincial Application has been approved through CTO but prior to submitting the Centre Application. By submitting this form in ROMEO you will be formally requesting the Board of Record Agreement. For information on how to complete the standard application tabs, click here.














All CHEO-specific study documents submitted to CTO and the CHEO REB must include a version date and version number which will be located in the document footer. Visit CTO and CHEO's REB for document templates.




http://www.ctontario.ca/streamlined-research-ethics-review-system/tools-and-resources/



Investigational Device Project Below will outline how to complete the Investigational Device Projects tab. Projects that include only a Class II, Class III or Class IV device (i.e., does not include an investigational drug, biologic or NHP) should be submitted using this application. The review stream (Full Board or Delegated) of these studies will be determined on a case-by-case basis. For information on how to complete the standard application tabs, click here.


Click here for more information on REB review fees. Any unfunded or solely investigator funded study is exempt from these fees.

Please reference SOP 412.001, CHEO REB Independent Peer Review Policy, for further details.











All investigator-sponsored studies initiated at CHEO will be monitored by the CHEO Quality Assurance department. Further, all studies (industry and investigator sponsored) must submit a monitoring plan to the REB as a part of the initial application. Please see SOP 901.002 for additional information.









Generally for Health Canada Division 5 regulated studies is 25 years after study closure. Visit the REB website for further details.








Applying for Awards or a Contract

Most investigators utilize the ROMEO Awards module for three purposes: to apply for internal funding competitions, to register external funding applications, and to request a contract.

Types of Internal Funding Submissions

CHAMO Innovation Grant (AHSC AFP Innovation Fund) Below will outline how to complete the CHAMO Innovation Grant (AHSC AFP Innovation Fund) tab. For information on how to complete the standard application tabs, click here. The CHAMO Innovation Grant has two parts. The first part is open to any applicant who meets the eligibility criteria, as defined by the competition guidelines. This consists of a one-page Notice of Intent (NOI) for your proposed project. For the initial step of the application, leave the Part II – Full Application subtab blank.

Note only the PI will be able to submit the application. For instructions on how to change the PI, click here. When Part 1 is submitted, you will receive a confirmation email. Note this is not the invitation to proceed to Part II. You will receive a second email which will contain a Notification of Acceptance to proceed with the full application.

For the initial step of the application, leave the Part II – Full Application subtab blank.



Once this notification is sent, the category Applications: Requiring Attention will be red and bolded. This is where you will find your application. You can then click Edit to return to your application and append the remaining documents. Note you will be continuing the initial application to submit Part 2.

Once the Part II tab has been completed and the remaining documents have been attached, the PI will be able to re-submit the application for full consideration.

CHEO RI ICES Research Grant The CHEO RI ICES Research Grant is intended for funding ICES research. For information on how to complete the standard application tabs, click here.

You may now complete the Part II subtab.

Please reference the competition guidelines for lay abstract requirements.



Research Growth Award (RGA) Below will outline how to complete the Research Growth Award (RGA) tab. For information on how to complete the standard application tabs, click here. The Research Growth Award Competition has two parts. The first part is open to any applicant who meets the eligibility criteria, as defined by the competition guidelines. This consists of a scientific abstract. For the initial step of the application, leave the Part II – Full Application subtab blank.

Note only the PI will be able to submit the application. For instructions on how to change the PI, click here. When Part 1 is submitted, you will receive a confirmation email. Note this is not the invitation to proceed to Part II. You will receive a second email which will contain a Notification of Acceptance to proceed with the full application.

Once this notification is sent, the category Applications: Requiring Attention will be red and bolded. This is where you will find your application. You can then click Edit to return to your application and append the remaining documents.

Note you will be continuing the initial application to submit Part 2.

Once the Part II tab has been completed and the remaining documents have been attached, the PI will be able to re-submit the application for full consideration.

For the initial step of the application, leave the Part II – Full Application subtab blank.

You may now complete the Part II subtab.



Quality Improvement Grant (QIG) Below will outline how to complete the Quality Improvement Grant (QIG) tab. For information on how to complete the standard application tabs, click here.

Click here for information on what should be included in your abstract.



Resident Research Grant Application Below will outline how to complete the Resident Research Grant Application tab. For information on how to complete the standard application tabs, click here. Please refer to the Resident Research Grant guidelines for additional information. Note the resident or fellow leading the project must be listed as PI on the awards file; the supervisor must be listed as a co-investigator. For information on adding or changing project team members, click here.

Your supervisor should be listed as PI on your REB application.

If you are conducting research at an alternate institution, a contract may be required. Please contact the contracts office for further information.




Summer Studentship Application Below will outline how to complete the Summer Studentship Application tab. For information on how to complete the standard application tabs, click here.

Note that you may apply to multiple summer studentships, however only one will be awarded per supervisor.

Do you require REB approval for this project? If yes, please apply early! REB applications for summer studentships are recommended to be submitted for the March deadline. Visit the REB website for more information on applying for REB approval. For information on how to use ROMEO for your REB submission, click here.


http://www.cheori.org/en/guidelinesprocedurespolicies


Types of External Funding Submissions

Research Registration Form The Research Registration Form is completed in order to register external funding applications for which you are the project or site PI. This allows you to track where you have applied to and the progression of the application. Once your Research Registration Form has been approved by the awards office, you will be able to request a contract through an event within the Research Registration Form, if required by your study. Below will outline how to complete the Research Registration Form tab. For information on how to complete the standard application tabs, click here.

Click here for information on submitting a contract. Note if REB approval is required for your study please apply early as to not delay the contracts process. Visit the REB website for more information on applying for REB approval. For information on how to use ROMEO for your REB submission, click here.

Patient engagement is an integral part of the research process. Please contact Rhonda Correll, Chief Operating Officer, for more information on how you can engage patients throughout your study.

http://www.cheori.org/en/guidelinesprocedurespolicies




Contract Submissions Any research being conducted by a CHEO RI appointed scientist or CHEO RI affiliated researcher including conducted at CHEO will require a study specific contract when a project involves interaction with an external party. For example CHEO RI requires a contract in the following situations;

• Transfer of funds (No funds can be transferred until there is a contract in place) • Transfer/sharing of data or samples (CHEO RI data/samples only, no external party

data/samples can be transferred) • Service arrangements

Contract Submission Process

Submit Awards Application

Awards Application approved

Submit Contract / Agreement event

within awards application

Contract request reviewed by

contracts office

Contract negotiated with

other party

Contract agreed upon by both parties, final

investigator review

REB Approval (if applicable)

Contract signed CHEO PI

Contract signed by CHEO RI

institutional signing authority

Contract signed by other party

Contract executed, study begins!


No Study or Funding Associated – Research Registration Form This form is intended for unfunded studies which involve the transfer of data, materials, or services. Once you have submitted the form and received an approval email, you will be able to submit the contract request form by following these steps. If you looking to submit an ARC Outbound MTA, please first complete this form. You will then be able to find the ARC Outbound MTA form in events. Below will outline how to complete the No Study or Funding Associated – Research Registration tab. For information on how to complete the standard application tabs, click here.

Funded study If your study is funded internally, you are able to submit for a contract as an event through your internal funding application by clicking here. If your study is funded externally, click here for instructions on completing a Research Registration Form in order to submit to the contracts office. If you have already completed a Research Registration Form, click here to submit a contract request.

Document how you will fund the project if you are not funding using an internal or external grant. If this project is funded by an internal or external grant, delete this application and see the Funded Study section below for further information.


Returned Applications

Your application may be returned by the REB or Awards office because it is incomplete, erroneous, or because you have successfully moved to the second phase of a two-phase application. For two-part award applications, follow the instructions for the CHAMO Innovation Grant (AHSC AFP Innovation Fund) or Research Growth Award (RGA). You will know your file has been returned because you will receive an email from the REB or Awards office.

When you log in to ROMEO, the category Applications: Requiring Attention will be red and bolded. This is where you will find your application. The number will indicate how many studies are in each category. This number will increase when an application is returned.

When you click on the quick link, you will be brought to a list of returned studies.

The Workflow Message will provide additional details on why the application was returned.

To view the full message, proceed to the Logs tab of the application and select Application Workflow Log

Find the appropriate study and click Edit.


Make any required changes within the initial application tabs. These changes are made by directly updating the information in the application.

Once you have reviewed your application, Re-Submit. Like the initial application, only the PI is able click Re-Submit.


Navigating Within a Project - Events

To submit an event, find the study which the event will be associated with. There are two ways to search for a file in ROMEO: You can search for the related file on the main page.

Type the four-digit ROMEO file number into the search bar and click the magnifying glass or Enter on your keyboard.

Or you can manually search through the Role Blocks. To do so, expand the appropriate Role Block for your role in the particular study (PI or Project Team Member).

Most of the events will be tied to a study in the category Applications: Post Review.

Find the study you are looking for and click Events. Reminder – you may have an awards and ethics file for the same study. Check the Application Type to be sure it says Certification/Human Ethics.

You can filter your view by typing in any of the text fields, clicking the associated filter button and selecting Contains


The events page is separated into two parts. First is a list of all events that could be associated to that file. For a Certification (REB) file, the list of events will include Annual Renewals, Adverse Event reporting, Deviation reporting, and acknowledgement forms. For an Awards file, the list of events will include Contract / Agreement Submissions, internal award reporting forms, and project status change forms.

Scroll down to the second section of the events page which contains any events tied to the file you had selected.

Events: Drafts – Projects with incomplete event forms not yet submitted for review. Events: Requiring Attention – Projects with event forms returned to the research team as they are incomplete or erroneous. Events: Under Review – Events not yet accepted for review by the REB

Events: Post Review – Events accepted for review by the REB or approved events Reminders – Quick reference to REB projects with upcoming annual renewals.

To alter an event you have already started, click Edit.


Ethics Events


Responding to REB Feedback When an application or event is submitted to the REB, the REB will often provide the investigator with feedback prior to approval. This feedback will be in the form of a letter emailed to the study team. This feedback is responded must be responded to using ROMEO within 90 days or receipt. To respond to REB feedback, submit an Investigator Response to REB Feedback event form to the appropriate certification file. Click here for information on accessing the Event forms.

Investigator Response to REB Feedback To respond to REB feedback, please write an itemized letter detailing the study team’s response to each piece of feedback, and submit this letter along with any updated study documents through the Investigator Response to REB feedback event. Click here for direction on where to access the Investigator Response to REB Feedback form in ROMEO.

This is a great place to add a quick reference to the Investigator Response. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

Any attached documents updated from the original submission should include a tracked changes and a clean version.

The REB feedback letter acts as an excellent template to help organize your response.


Ethics Events to Make Changes to your Study The Research Ethics Board must be notified of any changes to study design, conduct or documents, as well as any scientific findings that would impact the study. These modifications are submitted as Events in ROMEO and must be approved by the REB prior to being implemented.

Continuing Review Form – Major Modification Major modifications involve significant change to the study design or informed consent form. Such changes to studies presenting more than minimal risk will be reviewed by the Full Board as per the REB Meeting Schedule. For further information, visit the REB website. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the major modification. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

If you have closed your study and are looking to re-open it, complete the reactivation information.

Locally references enrollment at CHEO. If you are not enrolling at CHEO but are enrolling off-site, indicate 0.

Last approval references the last major modification, minor modification, or annual renewal approval.


http://www.cheori.org/en/majorandminormodifications


If your trial is regulated, you must submit a CTA-Amendment (CTA-A) or CTA-Notification (CTA-N). For information, click here or contact the Quality Assurance Program. CTA-Ns no longer receive a Non-Objection Letter. If you have submitted for a CTA-N and have not received an objection after 30 days, indicate this in your cover letter.

If changes are made that affect resource requirements from other departments, please attach written approval to your event submission.

https://cheonet.cheo.on.ca/research-learning/research-institute/clinical-research-unit/quality-assurance-and-education/guidelines-and-regulations



Continuing Review Form – Minor Modification for Delegated Review Minor modifications include any minor change to study documents or minor scientific change. These are reviewed through the delegated stream. Note these include changes of contact information for the investigator team. For further information, visit the REB website. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the minor modification. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.



http://www.cheori.org/en/majorandminormodifications


Minor Administrative or Editorial Changes Form Use this event to submit any minor changes to study documents that do not alter the trial, information provided to the participants, or the trial’s conduct. This includes correction of spelling / grammar errors and changes in research staff that would alter the contact information on study document. Note changes in research staff that only affect the project team on the ROMEO file and do not result in alterations to study documents are not submitted to the REB. Contact the ROMEO Administrator to make such changes. Ensure the individuals being added to the REB file have the appropriate Mandatory Training complete. Click here for information on accessing the Event forms.

Translated Study Documents All Informed Consent documents offered to patients and families must be available in French and English, as per the REB Bilingualism Policy. Click here for information on accessing the Event forms.

The signature page located in the Attachments tab asks the PI to attest to the translator’s level of language ability. If you are able to pay for translation, you may contact the translation company here. If you have a bilingual staff member who will be translating the documents, they must have an A+ level. Click here for information on language testing for the purpose of REB document translation.

This is a great place to add a quick reference to the minor change. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

Any attached documents updated from the original submission should include a tracked changes and a clean version.

This is a great place to add a quick reference to the documents translated. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.


http://www.cheori.org/en/rebbilingualismpolicy?id=0

https://cheonet.cheo.on.ca/central-services/human-resources-people/les-services-en-fran%C3%A7ais-language-services/services-de-traduction-translation-services

https://cheonet.cheo.on.ca/central-services/human-resources-people/les-services-en-fran%C3%A7ais-language-services/%C3%A9valuations-linquistiques-au-cheo-language-assessments-cheo


Ethics Events to Notify the REB of Issues or to Submit Reports Continuing Review Form – Serious Adverse Events (SAEs) Serious adverse events are defined as: congenital anomalies, significant disability or incapacity, prolonged hospitalization, and any other life-threatening or medically-important events. Any adverse event that is both serious and unexpected must be reported to the REB. For more information, visit the REB website. Regulated trials have specific SAE reporting procedures that must be followed. Visit the Quality Assurance webpage or contact the Quality Assurance Program for further information. Click here for information on accessing the Event forms.

Note: There is an SAE Reporting Form that must be submitted along with your documentation. Please view the attachments tab for this information.

Continuing Review Form – Protocol Deviation A protocol deviation is defined as any instance where the study procedure deviates from the REB approved protocol. This can be unintentional or implemented by the investigator to eliminate immediate risk or hazard. For further information visit the REB website. If you require assistance with corrective action in the case of a protocol deviation, contact the Quality Assurance Program. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the SAE. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.


This is a great place to add a quick reference to the reason for the deviation. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

http://www.cheori.org/en/rebadverseevents

https://cheonet.cheo.on.ca/research-learning/research-institute/clinical-research-unit/quality-assurance-and-education/forms-and-guidance

https://cheonet.cheo.on.ca/research-learning/research-institute/clinical-research-unit/quality-assurance-and-education/forms-and-guidance


http://www.cheori.org/en/rebprotocoldeviations



Acknowledgement form This form allows for the submission of any documents to the REB that do not require approval (i.e. Data Safety Monitoring Board Reports, Suspected Unexpected Serious Adverse Reactions (SUSAR) Summary Reports, Safety letters etc.). If there are resulting changes to any study documents based on these reports, submit a Minor Modification. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the acknowledgement type. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.


Annual Renewal Events All studies approved by the CHEO REB require renewal annually. Note a study’s expiry date is based on the date of study approval without modification by the board, not the date the study was submitted to the board by the research team. All project team members will receive an email reminder of the renewal 30 days prior to the due date. For a study submitted for Full Board Review, the renewal must be submitted to the REB prior to the next REB Submission Deadline. Click here for information on accessing the Event forms.

You will be able to directly click a link to the suggested renewal document within the reminders page. Note this form may not be accurate if your study is closed to accrual (no longer recruiting participants) or fully closed. Click here for information on the types of study closures, and reference SOP 401.0002 section 5.1.2 for information on cases when closed Full Board studies require delegated review. Note studies closed to accrual or temporarily closed will need to be renewed. Visit the REB website for additional information on Annual Renewals.

At 30 days prior to expiry, a link to the study requiring renewal will be found in the Reminders* category in ROMEO, which will be red, bold, and underlined.

Click Events to reach the Event Page for this application



http://www.cheori.org/en/rebannualreviews


Continuing Review Form – Annual Renewal for Delegated Review Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the renewal date. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

A study is Closed to Accrual if participants are no longer recruited at CHEO. They may continue to be followed for study purposes. Click here for information on the types of study closures.

Patients actively treated or followed at CHEO references only those treated or followed as a part of the study protocol. This does not include those treated or followed at CHEO for non-study related purposes.



Last approval references both annual renewals and modifications.


All documents should be attached as clean versions. No modifications can be made to study documents or procedures at the time of renewal. Please wait for your renewal to be approved prior to submitting Major, Minor, or Administrative Modifications.


Continuing Review Form – Annual Renewal for Full Board Review Click here for information on accessing the Event forms.



If your study is closed to recruitment and CHEO participants are no longer being followed for study purposes, click here for instructions on completing an Annual Renewal for Delegated Review.



Click here for information if you must submit a Protocol Deviation Form.



Study progress summary should include participant completion (lost to follow-up), overall recruitment if multi-centre study, and any issues or road-blocks to overcome.


Protocol Deviations must be submitted to the REB. If you have not yet submitted your Protocol Deviation, click here for further information.


Continuing Review Form – Annual Renewal for Prospective Chart Reviews Click here for information on accessing the Event forms.



If you are no longer collecting or verifying data, please submit a Study Closure – Retrospective Chart Review Form. An annual renewal is not required.

Total number of cases reviewed refers only to CHEO cases. If this is a multi-centre chart review, progress of other sites can be noted in the Study Progress tab.



Study progress summary should overall project status if multi-centre study, and any issues or road-blocks to overcome.

Protocol Deviations must be submitted to the REB. If you have not yet submitted your Protocol Deviation, click here for further information.


Prescribed Entity or Registry Annual Renewal Form Click here for information on accessing the Event forms.





Awards and Contracts Events

Types of Awards Events Capacity Building Report Click here for information on accessing the Event forms.

.

This is a great place to add a quick reference to the report date. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

Please use as much detail as possible when completing this section. Information will be used for fund allocation.

Performance measures should include successful and unsuccessful applications. Indicate the application’s success in this section as well.


Project Status Change Form Note the Project Status Change Form is only applicable to finance changes. If you require an amendment to an existing contract, please submit using the Contracts / Agreement Submission Form. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the change. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

If you are making a change to Delegation of Signing Authority, please complete the appropriate form available in the attachments tab.


Research Growth Award Report (Formerly the Feasibility / Start Up Grant Report) If you have been awarded a Research Growth Award, this report must be completed annually, including a final report at the end of your study. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the report date. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

Project summary should include recruitment or completion information, project status, and documentation of any issues.

Please include as much detail in this section as possible. Include any initial analysis, findings or achievements as applicable.

Remember to notify the Communications Department of your publications! If your content has broad appeal and you are targeting a high-impact journal, you may want to consider media outreach. Please contact public relations at the point where your manuscript is accepted for publication. To share your achievements with your CHEO colleagues, send along a hyperlink to communications for inclusion in the Discoveries Newsletter.



https://cheonet.cheo.on.ca/research-learning/research-institute/communications/internal-communications


Please include an updated budget if spending for the first year was not according to the initial budget.

Remember to notify the Communications Department of your progress. To share your achievements with your CHEO colleagues, include a hyperlink to your publication or a brief description inclusion in the Discoveries Newsletter.



Types of Contracts Events Arc Outbound MTA This contract is specific to ARC Agreements that are not associated to a particular study. For general contract submissions, click here. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to other party. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later. It will also be where the contracts team identifies the contract number.

If you have a coordinator or primary contact person, please insert their information here. This is typically the Research Coordinator. Correspondence will be primarily directed to this individual in addition to the PI.

Please complete the Other Party’s information to the best of your ability. Accurate and complete contact information will help speed up the negotiation process.

This information will be incorporated into your agreement. Please ensure it is complete and accurate. For assistance with material identifiers and permitted use, contact the Health and Safety Office.




Contract / Agreement Submission Form To submit a contract, you must have an existing ROMEO File for this project. If you do not already have a ROMEO file but have external funding, click here for instructions to submit the Research Registration Form. If you do not have funding or a study associated with your agreement, click here for the No Study/Funding Research registration Form. If you have an internal award, click on the appropriate award for further instructions CHAMO Innovation Grant, CHEO RI ICES Research Grant, Research Growth Award (RGA), Resident Research Grant Application. Summer Studentship Application). If you have a ROMEO Awards application for this study, continue with the steps below to submit a contract. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to other party. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later. It will also be where the contracts team identifies the contract number.

Your location is essential for streamlined delivery of documents for signature.

If you have a coordinator or primary contact person, please insert their information here. This is typically the Research Coordinator. Correspondence will be primarily directed to this individual in addition to the PI.


Please complete this form to the best of your ability. Accurate and complete contact information will help speed up the negotiation process. Please complete one Contract / Agreement Submission per contract required.

If you are unsure of the agreement type required for your study, select Other and describe your required document or contact the Contracts Office.

If the other party is initiating the agreement, please attach a Word version of the agreement to this event.

De-identified: A participant's data are assigned a random code. Direct identifiers are removed from the dataset and held separately. The key linking the code back to direct identifiers is available only to authorized members of the research team. (Adapted from N2 SOP Glossary of Terms)





Please ensure this information is accurate. Although you may submit your contract / agreement request prior to your REB application, internal review will not commence prior to REB application submission. REB approval must be obtained before the contract will be signed.

Please attach any documents referenced in the agreement. If the contract is initiated by another party, include a Word version of the draft contract.


Returned Events

Your event may be returned by the REB or Awards office because it is incomplete or erroneous. You will know your file has been returned because you will receive an email from the REB or Awards office.

When you log in to ROMEO, the category Events: Requiring Attention will be red and bolded. This is where you will find your event The number will indicate how many studies are in each category. This number will increase when an application is returned.

When you click on the quick link, you will be brought to a list of studies with returned events.

The Workflow Message will provide additional details on why the application was returned.

To view the full message, proceed to the Logs tab of the application and select Application Workflow Log

Find the appropriate study and click Edit.


Make any required changes within the initial event tabs. These changes are made by directly updating the information in the event.


Closing your Study

Ethics Closure Ethics Study Closure Definitions The REB must be notified of three types of study closures: Closed to Accrual: no further participants are being recruited at CHEO. Participants may continue to receive intervention, have follow up visits related to the study, or they may be recruited at other sites. Temporarily Suspended or Closed: the sponsor or study team determine the study must no longer recruit due to regulatory, safety, or oversight reasons. This is applicable to either the full study or an arm of the study. If you are looking to close your study to accrual or to temporarily close or suspend your study, complete a Change in Study Status form. Note you will need to submit annual renewals if your study falls into one of these categories. You may re-open your study by submitting a Major Modification in ROMEO. Permanently Closed: the study was never initiated and will not be initiated in the future, or if all data has been collected and verified. In these cases, a Study Closure form is completed in ROMEO. Note there is a separate form in ROMEO to close a retrospective chart review. For a prospective study, the typical flow is as follows: For a retrospective study, the Closed to Accrual status is often not applicable.

Recruit Participants

Active Study

Complete follow-up

Verify data

Close to Accrual

Permanent Closure


Continuing Review – Change in Study Status (NEW FORM added June 27, 2016) The Change in Study Status Form is used to change a study status from Active to Closed to Accrual or Temporarily Closed. Use the Study Closure or Study Closure Form for a Retrospective Chat Review to permanently close a study’s REB file. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the study closure. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

A study is closed to accrual when no further participants will be recruited at CHEO. Patients may or may not continue to receive intervention or have follow-up visits related to the study. A study is temporarily suspended or closed if the sponsor or REB determine the study must no longer recruit due to reasons of regulatory, safety, or oversight. This suspension or closure may apply to the full study or to an individual arm in a study. For more information, visit the REB website.


http://www.cheori.org/en/studyclosure


Continuing Review Form – Study Closure The study Closure form is to be completed if the study is being permanently closed, meaning the study is no longer collecting or verifying data nor is there a need to obtain any additional data. If your study is closed to accrual (no further participants will be recruited at CHEO; patients may or may not continue to receive intervention or have follow-up visits related to the study) or temporarily suspended or closed (the sponsor or REB determine the study must no longer recruit due to reasons of regulatory, safety, or oversight This suspension or closure may apply to the full study or to an individual arm in a study), please complete a Continuing Review – Change in Study Status form. For additional information on study closures, visit the REB website. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the Study Closure. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

Current status refers to the status you are submitting for this study (ie. permanently closed)









Continuing Review Form – Study Closure Retrospective Chart Review The study Closure form is to be completed if the study is being permanently closed, meaning the study is no longer collecting or verifying data nor is there a need to obtain any additional data. For additional information on study closures, visit the REB website. Click here for information on accessing the Event forms.

This is a great place to add a quick reference to the Study Closure. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

If you answer No to question 1.1, there is no need to complete this form.







Awards Closure The status of an awards file is only changed once all money that will be spent on this project is spent. This includes publications and travel for presentations, if permitted by the funding agency. As such, the awards file may be closed much later than the ethics file for the project.

Project Status Change Form The Project Status Change Form event form is also used to close a cost centre. For information on accessing events for an awards file, click here.

Recruit Participants

Active Study

Complete follow-up

Verify data

Close Awards file

Publish &

Present

This is a great place to add a quick reference to the change. Information in this section will be made visible in the Comments field of the Drafts section and will help you identify the event later.

Note the awards office may contact you for further details or for reporting purposes. Please promptly respond to any communications.


Contract Closure There is no need to notify the contracts office of a study closure assuming this closure has no impact on the contract. If your contract includes an end date and the study is completed prior to this date, the contract will simply be left to expire. The only instances requiring amendments are those where the fee schedule, deliverables, or budget are altered due to the study end date. In such cases, an amendment may be requested through a Contract / Agreement Submission.

Closing your study? Have you considered… Notifying the Communications department Inform the Communications Department of your publications! If your content has broad appeal and you are targeting a high-impact journal, you may want to consider media outreach. Please contact public relations at the point where your manuscript is accepted for publication. To share your achievements with your CHEO colleagues, send along a hyperlink to communications for inclusion in the Discoveries Newsletter

Accessing Quality Assurance Resources The Research Institute’s Quality Assurance Program is committed to providing investigators with the tools and resources to facilitate high quality research, including at the time of study close-out. Access the Study Close-out Checklist for a general overview of the actions require to close a study, the Study Close-out SOP (SOP 016_06) for drug destruction considerations, and the archiving guidance document for details on what to do with your CRFs.




https://cheonet.cheo.on.ca/research-learning/research-institute/clinical-research-unit/tools-and-templates

