If you are a Canadian site, affiliated with a Cooperative Group, and are interested in participating on CTSU trials:

1. Register your investigators and study staff with the CTSU (see CTSU Canadian Process Checklist for details on how to use the CTEP Account Management System to register with the CTSU.)
   
   
2. Determine trial availability by running a Canadian Study Status list from the link below:
   
   

   Canadian Status for Active CTSU Protocols Report by:

      

   Cancer Type

   Cooperative Group

   Protocol Number

   
   
   
3. Canadian study status is defined as one of six categories. A list of the study status categories and the actions that may be taken by the site with regard to each study status is available.
   
   
4. For studies where a Clinical Trial Application (CTA) is required for Canadian participation, the NCIC CTG prepares and submits the CTA and acts as trial sponsor in Canada. Under certain circumstances, the U.S. Cooperative Group leading the study will sponsor the CTA:
   
   
   1. If a Cooperative Group sponsors an IND in the U.S. for a study on the CTSU menu and has Canadian sites, then the Group will be responsible for submitting a CTA in Canada (as has been the customary policy). If the Group wishes, Dr. Joseph Pater (NCIC Chair) has agreed to serve as the Canadian Scientific Officer of record for these CTAs. This CTA will allow Canadian investigators to participate via their Group and will also allow CTEP-approved Canadian investigators from other Groups to enroll patients via the CTSU. The CTSU will be responsible for assuring the Lead Group holding the CTA that the the required Canadian regulatory information has been properly collected on all Canadian investigators entering patients via the CTSU.
      
      
   2. If a Cooperative Group sponsors an IND in the U.S. for a study on the CTSU menu but does not have Canadian sites, then the CTSU will contract with the NCIC to submit and sponsor a CTA in Canada for all Canadian investigators who wish to participate in the study. Canadian investigators must enter patients via the CTSU. The CTSU will be responsible for assuring NCIC that all Canadian regulatory information has been properly collected on all Canadian investigators enrolling patients via the CTSU.
      
      
   3. If CTEP sponsors an IND in the U.S. for a Cooperative Group study that is on the CTSU menu, then the CTSU will contract with the NCIC to submit and sponsor a CTA in Canada for all Canadian investigators who wish to participate in the study. Canadian investigators who are members of the Lead Group for a study must enter their patients via their Group. All other Canadian investigators must enter patients via the CTSU. The Lead Group and the CTSU will be responsible for assuring NCIC that all Canadian regulatory information has been properly collected on all Canadian investigators enrolling patients.
      
      
   4. If a Cooperative Group sponsors a study that does not require an IND in the U.S., but does require a CTA in Canada, then the CTSU will contract with the NCIC to submit and sponsor a CTA in Canada for all Canadian investigators who wish to participate in the study. Canadian investigators who are members of the Lead Group for a study must enter their patients via their Group. All other Canadian investigators must enter patients via the CTSU. The Lead Group and the CTSU will be responsible for assuring NCIC that all Canadian regulatory information has been properly collected on all Canadian investigators enrolling patients.
   
   
   
5. NCIC CTG (or if applicable, the lead U.S. Group sponsoring the CTA) informs CTSU once Health Canada has granted study approval. CTSU includes notification of Health Canada approval in the Canadian section of the upcoming CTSU Bi-Monthly Broadcast. CTSU also posts the following documents on the Canadian protocol specific web page:
   
   
   1. Canadian Sample Consent Form in English and French
      
   2. Qualified Investigator Undertaking (QIU)
      
   3. Clinical Trials Site Information (CTSI)
      
   4. Research Ethics Board Attestation (REBA)
   5. No Objections Letter (NOL)
   
   
   
6. If your local REB discontinues a protocol, or disapproves a protocol or an amendment to a protocol, notify the CTSU immediately. You will be given instruction in how to submit the REB refusal to CTSU, and CTSU will forward the documents to Health Canada.
   
   
7. Remember to submit an updated QIU if investigator responsibility changes hands.
   
   
8. CTSU only posts protocol versions that have been approved by Health Canada on the CTSU Canadian web pages. When study amendments are approved by Health Canada, CTSU includes notification of approval in the Canadian section of the CTSU Bi-Monthly Broadcasts and updates the protocol specific web pages with the new CTSI and REBA, and if indicated, the new model informed consents and case report forms.
   
   
9. A link to the Regulatory Requirements for Canadian Investigators document is provided in the Site Registration Documents section of each Canadian protocol page.
   
   
10. It is important to keep in mind that the process of Canadian CTA approval can be lengthy and complex and involves negotiations between NCIC CTG, drug manufacturers and distributors, regulatory bodies in both Canada and the U.S, and the Cooperative Group leading the study.