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.
- Review the applicable federal regulations for Investigator Initiated Trials, including sponsor and investigator responsibilities
- Review the steps involved in initiating an Investigator Initiated Trial and review regulatory reporting requirement of investigators and sponsors
- Identify essential documentation for the Sponsor-Investigator: Remaining audit ready
- Minimize risks associated with IITs by avoiding common pitfalls associated with IITs
- Review examples of regulatory deficiencies to Sponsor-Investigators
- Investigators/Site Study Team Members
- Sponsor Study Team Members
- Ethics Committee Members
Gary B. Freeman, M.S., C.C.R.A.
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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.