Canadian Cancer Trials Group Bulletins

Operations


Reminder - Canadian Cancer Trials Group Participation on Open CTSU Studies

In July 2006, the Canadian Cancer Trials Group changed the process for participating on US-led CTSU menu studies. This was announced at the 2006 Spring Meeting, and subsequently sent out to centres.

This is a reminder that for all US-led CTSU Menu studies (e.g., any study with a three letter code with a C at the end, such as ALC.1, or MAC.13), Canadian Cancer Trials Group centres will participate directly through the Canadian Cancer Trials Group Central Office for local activation, registration and randomizations -- as you would for all other studies.

Canadian trial specific documents will not be posted on the CTSU website but will be available on the Canadian Cancer Trials Group trial specific web site at http://www.ctg.queensu.ca. You should refer only to the Canadian Cancer Trials Group website for approved documents for Canadian participation.

All documents required for trial participation, including new initial and annual REB approvals, REB approvals of amendments, Health Canada forms (qualified investigator undertaking, REB Attestations), should be sent directly to Canadian Cancer Trials Group for processing.

At the time of patient registration and randomization, centres will be required to fax to the Canadian Cancer Trials Group registration desk all trial specific enrolment forms and checklists, as well as a signed patient consent form. These documents must be faxed to the Canadian Cancer Trials Group registration desk at 613-533-2941.

Information, including the protocol, Canadian appendix and case report forms, should be retrieved from the Canadian Cancer Trials Group website only, not the CTSU website. We will be the conduit for all communication with CTSU regarding your participation on these studies. All questions regarding study logistics, Canadian site activation and drug supply for CTSU menu trials should be directed to the Canadian Cancer Trials Group Study Coordinator. Questions regarding the study protocol (e.g., eligibility, treatment) and case report form completion should be directed to the Lead Group contact. You can find the contact information on the trial specific page of the website.

Please note that Canadian centres are required to send all completed case report forms for all studies directly to the Lead Group office -- not to the CTSU, and not to the Canadian Cancer Trials Group central office. These instructions will be in the protocol/Canadian appendix. You will receive data queries directly from the Lead Group, and query replies should be sent directly back to the Lead Group.

Canadian Cancer Trials Group will communicate directly with the CTSU/Lead Groups to provide them with centre specific, and trial specific contacts at your centre. If you receive queries about centre contacts from the CTSU directly, please direct them to the Operations department at the Canadian Cancer Trials Group central office.

If you have any questions about this, please do not hesitate to contact Belinda Vandersluis at bvandersluis@ctg.queensu.ca.