Resources

22/23 REB Exchange
Annual Report

Cover for year 2 annual report

Read about how Western Canada is “Paving Pathways” for more collaborative and efficient research processes, both at home and abroad.

Lead Site vs. pSite Responsibilities in REBX

STUDY-WIDE SUBMISSIONS

SITE-SPECIFIC SUBMISSIONS

Lead Site Application

pSite Application

Study Amendments:

  • Changes to protocol
  • Changes to consent/assent form(s)
  • Changes in other participant materials
  • Updated IB/PM
  • Other changes in previously submitted information

pSite Amendments:

  • Changes to local consent/assent form(s)
  • Changes in other site-specific participant materials
  • Other changes in previously submitted site-information
  • Changes in local study team

Study Annual Renewal

pSite Annual Renewal

Study Reportable Events

  • DSMB/C Report
  • Interim Analysis Results
  • Safety Notice/Update (e.g., Action Letter), Periodic External (non-local) AE/SUSAR Summary Report, Single External (non-local) Adverse Event meeting reporting definition

pSite Reportable Events

  • Local (internal) Serious Adverse Event meeting reporting definition
  • Protocol Deviation/Violation
  • Privacy Breach
  • Audit/Inspection Report
  • Participant Complaint

Study Closure/Completion Can only be submitted after each pSite has submitted their own Study Closure form.

pSite Closure/Completion Submit once research activities at the site are complete and ethics approval is no longer required for the site.

User Guides

For Everyone

A summary of how the REB Exchange makes multi-site studies easier to manage (PDF).

For Lead Sites

Invite up to 6 participating sites to your approved study (PDF)

Next steps after inviting a pSite to your approved study. (PDF)

Learn how to initiate a renewal for multi-site studies. (PDF)

For Participating Sites (pSites)

Next steps after receiving an invitation to an approved study. (PDF)

Learn how to renew your site to coincide with the Lead Site. (PDF)

FAQ

About REB Exchange

Definitions: Lead Site, pSite, Sponsor

Lead Site = the researcher who submits the initial ethics application and invites others to collaborate

Participating Site or pSite = the researcher who submits the site-specific documents and collaborates with the lead researcher

Sponsor = the researcher, institution, or partner who initiated the research project

What is the REB (Research Ethics Board) of Record?

A Research Ethics Board of Record, also known as an REB of Record or Board of Record (BoR), provides research ethics review and oversight for a study with multiple participating sites.

This means, only one Research Ethics Board (REB) reviews and approves the ethics of a study for more than one site.

Creating Multi-Site Studies

Can any study become a multi-site study with REB Exchange?

Any approved study can invite pSites to apply to the approving board for corresponding ethics approvals.

How many pSites can I add?

The default settings allow you to add up to 6 pSites per institution.

Do I have to add all my pSites at once?

No, you can add pSites at any time, once you have your ethics board approval.

Managing Multi-Site Studies

Can I see the progress of a pSite application?

Yes, you can see the pSites as they move through the application process. You will receive automated system notifications.

Who keeps the documentation for approvals, modifications, etc?

All documentation is maintained within REBX, so lead and pSites are aware of any modifications, renewals, etc. The most up-to-date versions are always in REBX, and accessible via IRISS or ARISE.

Who is responsible for renewals?

There is a single ethics expiry date for the entire study and all pSites; this date is based on the date of ethics approval for the Lead site. Annual Renewal Applications must be submitted to the REB of Record in order to renew ethics approval for your study. Renewals must be submitted at both the study and site level.

Who is responsible for protocol changes?

The Lead Site must submit any changes to the protocol. One the modification is approved, it will apply to all sites.

Can lead and pSite modify a study simultaneously?

Yes, there is no conflict.

Get Support

For support on REB Exchange, please contact the help desk at your institution:

Explore REB Exchange with an expert