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Although administrative health care databases have long been used to evaluate adverse drug effects, responses to drug safety signals have been slow and uncoordinated. We describe the establishment of the Canadian Network for Observational Drug Effect Studies (CNODES), a collaborating centre of the Drug Safety and Effectiveness Network (DSEN). CNODES is a distributed network of investigators and linked databases in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec and Nova Scotia. Principles of operation are as follows:(1) research questions are prioritized by the coordinating office of DSEN;(2) the linked data stay within the provinces;(3) for each question, a study team formulates a detailed protocol enabling consistent analyses in each province;(4) analyses are “blind” to results obtained elsewhere;(5) protocol deviations are permitted for technical reasons only;(6) analyses using …