Canadian Cancer Trials Group Bulletins

Office of Compliance and Oversight


New Pharmacy Compliance Requirement/Updated CTMB Guidelines

New pharmacy compliance requirements pertaining to drug accountability and agent storage have recently been introduced by CTEP. In addition to ensuring that each agent is stored separately by protocol, strength and formulation, it is now required that NCI-supplied agent be stored separately by ordering investigator. Also, for NCI-supplied agent separate Drug Accountability Logs must now be maintained for each protocol, agent, strength, formulation and ordering investigator.

These requirements are in accordance with CTEP's Pharmaceutical Management Branch (PMB) Policy and Guidelines for Accountability for Investigational Agents which can be found on the PMB website http://ctep.cancer.gov/protocolDevelopment/requisition_agents/docs/storage-03.pdf.

The Clinical Trials Monitoring Branch (CTMB) Audit Guidelines were also recently updated and include these new pharmacy compliance requirements. In addition there were a number of administrative/editorial changes related to the transition to the NCI National Cancer Trials Network (NCTN) program. The guidelines titled "NCI Guidelines for Auditing Clinical Trials for the NCI National Clinical Trials Network (NCTN) Program, Community Clinical Oncology Program (CCOP)/NCI Community Oncology Research Program (NCORP) and Research Bases" are posted on the NCI/CTEP/CTMB website at the following link:
http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm.

A copy of the guidelines and a "Summary of Changes" are also posted on the Office of Compliance and Oversight website at the following link http://www.ctg.queensu.ca/private/compliance/tools/default.html

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