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Research ArticleContinuing Education

SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Regulatory Process, Part I: How and When Radiopharmaceuticals Can Be Used

Charlotte Denise Jeffers, Sarah A. Frye and John M. Hoffman
Journal of Nuclear Medicine Technology March 2022, 50 (1) 2-9; DOI: https://doi.org/10.2967/jnmt.121.263499
Charlotte Denise Jeffers
1Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama;
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Sarah A. Frye
2Department of Clinical Health Sciences, Saint Louis University, St. Louis, Missouri; and
CNMT, NMTCB(PET), NMTCB(NCT), CCRP
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John M. Hoffman
3Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah
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Article Information

vol. 50 no. 1 2-9
DOI 
https://doi.org/10.2967/jnmt.121.263499
PubMed 
34933923

Published By 
Society of Nuclear Medicine
Print ISSN 
0091-4916
Online ISSN 
1535-5675
History 
  • Received for publication November 10, 2021
  • Revision received December 16, 2021
  • Published online March 3, 2022.

Article Versions

  • previous version (December 21, 2021 - 06:08).
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Copyright & Usage 
© 2022 by the Society of Nuclear Medicine and Molecular Imaging.

Author Information

  1. Charlotte Denise Jeffers1,
  2. Sarah A. Frye, CNMT, NMTCB(PET), NMTCB(NCT), CCRP2 and
  3. John M. Hoffman3
  1. 1Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama;
  2. 2Department of Clinical Health Sciences, Saint Louis University, St. Louis, Missouri; and
  3. 3Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah
  1. For correspondence or reprints, contact Charlotte Denise Jeffers (charlottejeffers@uabmc.edu).
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Journal of Nuclear Medicine Technology: 50 (1)
Journal of Nuclear Medicine Technology
Vol. 50, Issue 1
March 1, 2022
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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
Charlotte Denise Jeffers, Sarah A. Frye, John M. Hoffman
Journal of Nuclear Medicine Technology Mar 2022, 50 (1) 2-9; DOI: 10.2967/jnmt.121.263499
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  • Article
    • Abstract
    • BACKGROUND
    • DEFINITIONS
    • OVERVIEW OF RADIOPHARMACEUTICAL CLINICAL RESEARCH PROCESSES
    • IND APPLICATION FOR MARKETED DRUGS
    • IND APPLICATIONS
    • RDRC
    • CONCLUSION
    • DISCLOSURE
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  • SNMMI Clinical Trials Network Research Series for Technologists: An Introduction to Conducting Theranostic Clinical Trials
  • SNMMI Clinical Trial Network Research Series for Technologists: Application of Good Clinical Practice to Clinical Research in Medical Imaging
  • SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer--Use of Imaging Agents in Therapeutic Drug Development and Approval
  • 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
  • 2022--A "Ditto" of 2021?
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More in this TOC Section

  • Illuminating the Hidden: Standardizing Cardiac MIBG Imaging for Sympathetic Dysfunction
  • PET/CT Case Series: Unmasking the Mystery of Cardiac Sarcoidosis
  • Delivery Methods of Radiopharmaceuticals: Exploring Global Strategies to Minimize Occupational Radiation Exposure
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  • SNMMI Clinical Trial Network Research Series for Technologists: Application of Good Clinical Practice to Clinical Research in Medical Imaging
  • 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
  • SNMMI Clinical Trials Network Research Series for Technologists: Introduction
See more

Keywords

  • radiopharmaceutical
  • clinical research
  • clinical trial
  • investigational new drug
  • investigational new drug application
  • radioactive drug research committee
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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
Charlotte Denise Jeffers, Sarah A. Frye, John M. Hoffman
Journal of Nuclear Medicine Technology Mar 2022, 50 (1) 2-9; DOI: 10.2967/jnmt.121.263499

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