Canadian Cancer Trials Group Bulletins

Office of Compliance and Oversight


Updated CTMB Guidelines: New Pharmacy Review Requirement

The 2012 update to the NCI US Clinical Trial Monitoring Branch (CTMB) "Guidelines for Auditing of Clinical Trials for Cooperative Groups, CCOP Research Bases and the Cancer Trials Support Unit (CTSU)" have been finalized and are available on the CTMB website at http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm. The effective date for the new guidelines is 2013Jan01.

A copy of the document with highlighted changes is also available on the Canadian Cancer Trials Group Compliance Group website at http://www.ctg.queensu.ca/private/compliance/tools/default.html

To ensure compliance with the guidelines, pharmacy reviewers on Canadian Cancer Trials Group's standard on-site monitoring program (OSM-C) are now required to verify that NCI US-supplied agent is prescribed by an investigator registered with the PMB or that the order/prescription is co-signed by a registered investigator. Pharmacies will also be expected to have documented procedures in place for ensuring the ordering physician is currently registered with the PMB or the prescription is co-signed by a registered investigator.

If you have questions, please contact Tracy Boyd, Monitoring Team Leader (tboyd@ctg.queensu.ca).

Additional links/resources:
http://ctep.cancer.gov/investigatorResources/docs/InvestigatorHandbook.pdf
http://ctep.cancer.gov/investigatorResources/investigator_registration.htm
http://ctep.cancer.gov/branches/pmb/expiration_date.htm