The CTSU has made great efforts to increase Canadian participation on CTSU-supported protocols. Canadian sites have a dedicated Canadian home page link from both the CTSU public and member web sites. The Canadian home page describes the requirements and processes for Canadian sites to register and enroll patients via the CTSU. The CTSU has also created the Canadian protocol pages, these pages are both protocol and Canadian specific, allowing sites to download site registration regulatory documents, patient enrollment documents, protocol documents, Case Report Forms, adverse event reporting forms, and education and promotion materials.

CTSU Public Site

On the CTSU Public Site home page there is a tab to click for Canadian sites. Clicking this tab will bring you to the Canadian home page; the home page on the public site is the same as that on the members site.

CTSU Member Site

On the CTSU members home page under the Resources tab you will find the link "Information for Canadian sites" (easily identifiable with a Canadian flag). By clicking on this link, you will be directed to the CTSU Canadian home page.

• Register your Investigators and staff with the CTSU by accessing the CTEP Account Management System. Instructions on how to do this are detailed in the CTSU Canadian Process Checklist, which offers a step-by-step diagram outlining the process of Canadian participation on CTSU trials.
• CTSU active protocol reports have been tailored to Canadian sites and include the Canadian protocol status. Protocols open for Canadian participation will be distinguishable with a Canadian flag marked at the Protocol ID. These reports are also available on the "Protocols" section of the CTSU members site.
• Canadian protocol status is defined as one of six categories. A list of the protocol status categories and the actions that may be taken by the site with regard to each status is available. An overview of the Clinical Trial Application (CTA) process as it relates to CTSU Canadian participation is provided.
• For trials with CTA agreements, once Health Canada has granted study approval, CTSU includes notification in the Canadian section of the upcoming CTSU bimonthly broadcast.
• For trials with CTA agreements, a link to the generic document entitled Regulatory Requirements for Canadian Investigators is provided. Access to this document can also be found on the Canadian protocol pages under Site Registration Documents.

• The Canadian protocol page is identical to the U.S. protocol page if this is a nondrug study or if the study agents are considered noninvestigational in Canada.
• The Canadian protocol page will differ from the U.S. protocol page if the study agents are considered investigational in Canada. CTSU posts only protocol versions that have been approved by Health Canada. Protocol updates pending Health Canada approval may be downloaded from the corresponding U.S. protocol page for submission to your research ethics bound. When study amendments are approved by Health Canada, CTSU includes notification of approval in the Canadian section of the CTSU bimonthly broadcast and updates the Canadian protocol page with the new protocol and amendment, CTSI, REBA, NOL and, if indicated, the new model informed consents and Case Report Forms. For each protocol covered under a CTA, the CTSU will post the following Canadian-specific regulatory and forms documentation:
• Canadian Sample Consent Form in English and French
• Qualified Investigator Undertaking (QIU)
• Clinical Trials Site Information (CTSI)
• Research Ethics Board Attestation (REBA)
• No Objections Letter (NOL)
• When the NCIC-CTG holds the CTA for a protocol sponsored by another Cooperative Group they will perform an independent review of safety information related to that study and may issue an additional notification for Canadian Investigators and REBs. NCIC-CTG sends these notices to the CTSU for Web posting under the "protocol documents" section of the study-specific Canadian page only. CTSU adds a note below the document link stating that "Health Canada considers this event reportable to Canadian investigators and REBs". CTSU also posts the notice and accompanying report on the main CTSU homepage under 'Protocol Updates' and lists it under the Canadian investigators section of the CTSU bi-monthly broadcast.