Can CARE, the ISR Committee, or other Boston Scientific experts help me develop a protocol or statistical analysis plan?
No. As part of the requirements for product promotion, investigator-sponsored trials must be “unsolicited.” Boston Scientific is allowed to post generalized areas of interest, but cannot participate in study concept generation or protocol development. Once the protocol is developed, the committee may ask questions to clarify the design or may offer general advice if the proposal needs more structure. However, you must maintain your role as the author and owner of the project.