Program Description: As a researcher, do you know when the regulations dictate that an IND or IDE must be filed with the FDA? When a researcher becomes a sponsor-investigator, it is imperative they understand the specific obligations in their roles as both the investigator and sponsor of the study. This presentation will review the responsibilities of a sponsor-investigator in relation to an IND or IDE, including safety and progress reporting.
Upon completion of this Webinar, attendees should be able to:
- Identify the responsibilities as a sponsor-investigator
- Identify when an IND/IDE should be submitted
- Distinguish the type of reports that need to be completed for an IND/IDE
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