Investigator Initiated Trials (IITs), also referred to as Sponsor-Investigator (SI) Trials are increasing in popularity. A Sponsor-Investigator is anyone who functions as the Clinical Investigator (CI) of a given study and who also holds the investigational marketing application, i.e., the IND or IDE. How does the CI ensure compliance to both the investigator and sponsor responsibilities? This web seminar will present the responsibilities, discuss risk, and provide suggestions for compliance.
- Define an Investigator Initiated Trial (IIT)
- Review the applicable federal regulations for IITs, including sponsor and investigator responsibilities
- Review the steps involved in initiating an IIT with a sponsor and review regulatory reporting requirements
- Identify essential documentation (Trial Master File) for the Sponsor-Investigator using the DIA TMF Reference Model to remain audit ready
- Identify approaches to minimize risks associated with IITs by avoiding common pitfalls – learn from existing FDA Warning Letters of deficiencies
- Investigators/Site Study Team Members
- Sponsor Study Team Members
- Ethics Committee Members
Elizabeth Ronk Nelson, M.P.H.
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.