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- Study criteria
- Support requested
- Review process
Following study approval, Biogen will draft an agreement and engage in negotiations with you and your institution. Contract negotiations typically take 3-4 months, but can take longer depending on the study circumstances and whether your institution accepts Biogen standard practice regarding issues such as intellectual property clauses, indemnification, and publication rights. Biogen would urge investigators to contact their organization’s sponsored research office to monitor the process of contracting. Biogen cannot be responsible for delays caused by the investigator’s sponsored research office.
Due to the collaborative nature of SRA studies, Biogen implements a transfer of responsibilities document as part of the contracting process. This document clearly outlines the responsibilities of both Biogen and the investigator throughout the course of the study.
As a condition of accepting support, the investigator agrees to report SAEs for studies involving human subjects, ensure all local regulations are followed in conducting the study, seek Ethics Committee approval if required, and provide a final study report, and advance copies of all presentations and publications emanating from the work.
- Study conduct