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Seminar Summary:

Learn various IRB models, regulatory framework for IRB review, 21 CFR 50, 56 and 45 CFR 46, current issues regarding IRB review, more. (see full course description)

 
 
 

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Training Course Syllabus:


IRBs and the changing landscape Webinar

This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.

The number of clinical trials continues to increase. Clinical trials are no longer solely conducted at academic research centers or hospitals. Stand-alone facilities set up to conduct research are being established. Partnerships are being formed between traditional centers and the community. Multi-site studies are becoming the standard. Yet the regulations have not changed and IRBs must interpret what is currently available to them in order to review and approve clinical trials. Included in the mix is pressure for IRBs to move faster and to consolidate their reviews. This has prompted a variety of new IRB review models.

Areas Covered


  • IRB models, including IRB as the HIPAA Privacy Board

  • Current issues surrounding IRB review

  • Regulatory framework for IRB review: 21 CFR 50, 56 and 45 CFR 46

  • Assurances and agreements to facilitate IRB review

  • Potential use of IRB Consortiums

  • Accreditation and how this has changed IRBs

  • Why Should you Attend:

    This webinar will explain IRB models, including IRB as the HIPAA Privacy Board. It will discuss the current issues surrounding IRB review and potential use of IRB consortiums.



Objectives of the Presentation:


  • Learn about various IRB models

  • Understand when various models are used

  • Become familiar with assurances and their uses

  • Delve into what the future may hold

Seminar Summary:

Learn various IRB models, regulatory framework for IRB review, 21 CFR 50, 56 and 45 CFR 46, current issues regarding IRB review, more. (see full course description)

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