{"id":2450,"date":"2016-07-06T13:44:13","date_gmt":"2016-07-06T17:44:13","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/crro\/?page_id=2450"},"modified":"2023-06-07T12:16:32","modified_gmt":"2023-06-07T16:16:32","slug":"sponsor-investigator-training","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/crro\/training-education\/sponsor-investigator-training\/","title":{"rendered":"Sponsor-Investigator Training"},"content":{"rendered":"

Offered on an as-requested basis, this training is required for Principal Investigators who are also taking on the role of Sponsor for an FDA-regulated drug or device study per <\/span>HRPP Policy 6.2.3.1<\/span><\/a>. A sponsor is an individual who holds an IND (Investigational New Drug) or IDE (Investigational Device Exemption) and is responsible for the initiation, conduct, and overall oversight of the clinical trial.\u00a0<\/span><\/p>\n

Sponsor-Investigator training is held upon request and is one 2-hour session. While this training is required for the PI serving as an Sponsor-Investigator, any member of the research team can attend at the PI\u2019s discretion.\u00a0<\/span><\/p>\n

Please <\/span>contact us<\/span><\/a> to schedule the Sponsor-Investigator Training. Note that training is required to be completed prior to IRB approval of research. We recommend that the training request be submitted to us at the same time as IRB submission to ensure completion prior to study approval.\u00a0<\/span><\/p>\n

It is also recommended that all Sponsor-Investigators complete <\/span>PI Training<\/span><\/a> to gain a more fundamental understanding of the oversight responsibilities any Principal Investigator has. This is not required as a prerequisite for requesting Sponsor-Investigator training, only a recommendation.\u00a0<\/span><\/p>\n

Additional Resources for Sponsor-Investigators<\/b><\/h5>\n