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
- 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
Gary B. Freeman, M.S., C.C.R.A.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-16-041-L01-P. Released: 9/16.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.