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FDA Guidance: IRB Continuing Review of Clinical Investigations

Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

Course Description

This course will review the content of the 2012 final guidance for continuing review of Institutional Review Board (IRB) approved research. In response to changes within the industry and the conduct of clinical research, the FDA highlights an updated approach to sponsor, IRB, and Clinical Investigator interaction by encouraging investigators and sponsors to ensure that IRBs receive meaningful study-wide information, particularly when doing so may assist IRBs in reviewing the studies and protecting subjects. This guidance also recommends particular areas where IRBs should focus to ensure meaningful review and approval. In this web seminar, the implications of how this guidance affects the essential documentation practices and activities between the sponsor, investigator, and the reviewing IRBs will be examined.

Learning Objectives

  • Describe the history of what led to the guidance release and its risk-based focus
  • Describe the recommendations regarding the criteria, process, and frequency of continuing review
  • Identify how the guidance recommendations differ from current practices
  • Discuss the implications of the guidance on sponsor, investigator, and IRB activities
  • Review case scenarios, including recent warning letters

Who Should Attend

  • Investigators
  • Site Managers
  • Research Coordinators
  • IRB Professionals
  • Clinical Research Associates
  • Regulatory Professionals
  • Sponsor/CRO Managers
  • Quality Assurance Personnel

Instructor

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies 

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 1.5 hours (0.15 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#: 0778-0000-12-073-L01-P. Released: 7/12. 

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 

 

 

 

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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

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.

For more details on this scenario-based eGCP program for investigators please click here. 


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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)