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Research ArticleContinuing Education

SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Regulatory Process, Part II: The Role of the Institutional Review Board in Food and Drug Administration–Regulated Radiopharmaceutical Research

Charlotte D. Jeffers and John M. Hoffman
Journal of Nuclear Medicine Technology June 2022, 50 (2) 97-102; DOI: https://doi.org/10.2967/jnmt.122.264034
Charlotte D. Jeffers
1Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama;
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John M. Hoffman
2Department of Radiology and Imaging Sciences, Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah
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Article Information

vol. 50 no. 2 97-102
DOI 
https://doi.org/10.2967/jnmt.122.264034

Published By 
Society of Nuclear Medicine
Print ISSN 
0091-4916
Online ISSN 
1535-5675
History 
  • Received for publication February 17, 2022
  • Revision received April 25, 2022
  • Published online June 3, 2022.

Copyright & Usage 
© 2022 by the Society of Nuclear Medicine and Molecular Imaging.

Author Information

  1. Charlotte D. Jeffers1 and
  2. John M. Hoffman2
  1. 1Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama;
  2. 2Department of Radiology and Imaging Sciences, Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah
  1. For correspondence or reprints, contact Charlotte D. Jeffers (charlottejeffers{at}uabmc.edu).
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Journal of Nuclear Medicine Technology: 50 (2)
Journal of Nuclear Medicine Technology
Vol. 50, Issue 2
June 1, 2022
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SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Regulatory Process, Part II: The Role of the Institutional Review Board in Food and Drug Administration–Regulated Radiopharmaceutical Research
Charlotte D. Jeffers, John M. Hoffman
Journal of Nuclear Medicine Technology Jun 2022, 50 (2) 97-102; DOI: 10.2967/jnmt.122.264034

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SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Regulatory Process, Part II: The Role of the Institutional Review Board in Food and Drug Administration–Regulated Radiopharmaceutical Research
Charlotte D. Jeffers, John M. Hoffman
Journal of Nuclear Medicine Technology Jun 2022, 50 (2) 97-102; DOI: 10.2967/jnmt.122.264034
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  • Article
    • Abstract
    • DEFINITIONS AND TERMS
    • IRB PURPOSE, REGISTRATION, AND MEMBERSHIP
    • TYPES OF IRBS
    • IRB FUNCTIONS AND OPERATIONS: 21 CFR §56[C]
    • IRB APPROVAL OF CLINICAL RESEARCH, AMENDMENTS, AND DEVIATIONS
    • HOW IS THE IRB MONITORED?
    • CONCLUSION
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  • SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Regulatory Process, Part I: How and When Radiopharmaceuticals Can Be Used
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Keywords

  • radiopharmaceutical
  • clinical research
  • clinical trial
  • institutional review board
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