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- Study criteria
- Support requested
- Review process
Following the approval of the study, including a developed protocol for appropriate/clinical studies, Biogen’s legal department drafts an agreement and engages in negotiations with you and your institution. These contract negotiations typically take 3-4 months to finalize, but can take longer depending on the study circumstances (e.g. the type of study, intellectual property clauses, indemnification, and the complexity of the study).
For both Investigator-Initiated Trials (IITs) and Sponsored Research Agreements (SRAs), the investigator and/or his/her institution retain regulatory sponsorship for the study. However, 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.