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Investigator Initiated Trials: Roles and Responsibilities November 2011

Course Description

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.

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Learning Objectives

  • 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

Who Should Attend

  • Investigators/Site Study Team Members
  • Sponsor Study Team Members
  • Ethics Committee Members

Instructor

Gary B. Freeman, M.S., C.C.R.A., C.C.R.T.

Click here for complete trainer biographies 

Course Length Time

2 hours; 12:00 – 2:00 p.m. Eastern

Course Dates

November 29, 2011

Registration Fees

$695

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.

Accreditation Information

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. 

 

 

 

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Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)