Canadian Cancer Trials Group Bulletins

Operations


OPEN -- New Initiative of the CTSU

Oncology Patient Enrollment Network (OPEN) is a new initiative of the Cancer Trials Support Unit (CTSU) to facilitate enrollment to Cooperative Group clinical trials. OPEN is a web-based portal for enrollments to CTSU menu clinical trials. The OPEN program 'talks' to each of the Cooperative Group's randomization and enrollment systems. You may have received information in the bi-weekly CTSU bulletin or directly at your centres.

For studies where Canadian Cancer Trials Group endorses a CTSU menu study, hold the Health Canada Clinical Trials Application, and coordinates Canadian participation onto the studies will be managed as usual. To be specific, the Canadian Cancer Trials Group has been coordinating Canadian local activations and enrollments since 2006 and this will not change. For any of these studies (those with a C as the 3rd letter, e.g. MAC12, PRC2, etc.) please continue to contact the Canadian Cancer Trials Group Central Office for your participation and enrollments as usual. The Canadian Cancer Trials Group Central Office will process the enrollments through OPEN.

One new aspect of the OPEN project is that we need to provide more information about centre staff into the Regulatory Support System (RSS). We encourage centres to have their CRAs and other data management staff who are involved with CTSU menu studies to register for a CTEP-IAM number. If you do not already have a CTEP-IAM account, here is the link to the registration website: https://eapps-ctep.nci.nih.gov/iam/privacyActDisclaimer.do?method=showDisclaimerText. The process takes a few days. If you require any more information or help getting a CTEP-IAM number, please feel free to contact either Belinda Vandersluis or Debbie Soroka in the Operations department at Central Office. If you are contacted by CTSU for your contact information, please refer them back to the Central Office Operations department. It's important to ensure synchronization between our membership roster and the CTSU RSS.

If you have questions about this, please contact Belinda Vandersluis @ bvandersluis@ctg.queensu.ca or 613-533-6430.