Common use of Safety Coordinator Clause in Contracts

Safety Coordinator. The Safety Coordinator is responsible for the coordination of all activities relating to safety and will be based in Sydney. The Safety Coordinator will also be responsible for the generation of, and any required revisions to, the Study Safety Plan, a comprehensive document, which defines the process and flow for contracted safety services. In addition, a Safety Master File will be set up. Safety coordination also includes assistance with the SAE reconciliation process, and completion of sponsor derived queries of the sites. Omnicare CR will utilise the safety database developed for other on-going Sponsor projects (PCN KO1601 and KO1602 Actinic Keratoses studies). A Safety Officer will be appointed in the US to provide monthly database maintenance and enter the data into the **** database.