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., C.C.R.T.
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2 hours; 12:00 – 2:00 p.m. Eastern
November 29, 2011
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 1-800-856-2556 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 mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-10-032-L01-P. Released: 8/10.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.