xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05984082</url>
    </required_header>
    <id_info>
      <org_study_id>853845</org_study_id>
      <nct_id>NCT05984082</nct_id>
    </id_info>
    <brief_title>Checklist for AI in Medical Imaging (CLAIM) Consensus Panel</brief_title>
    <acronym>CLAIM</acronym>
    <official_title>Checklist for AI in Medical Imaging (CLAIM) Consensus Panel</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pennsylvania</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators will revise the Checklist for AI in Medical Imaging (CLAIM) guideline using&#xD;
        Delphi consensus methods. An international panel of physicians, researchers, and journal&#xD;
        editors with expertise in AI in medical imaging -- including radiology, pathology,&#xD;
        dermatology, GI endoscopy, and ophthalmology -- will complete up to 3 web-based surveys.&#xD;
        Participants who complete all survey rounds will be credited as contributors on resulting&#xD;
        publications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The survey will be administered in collaboration with:&#xD;
  &#xD;
          -  Anthony A. Gatti, PhD (Stanford University)&#xD;
  &#xD;
          -  Michail E. Klontzas, MD, PhD (University of Crete School of Medicine) *&#xD;
  &#xD;
          -  Linda Moy, MD (New York University Grossman School of Medicine)&#xD;
  &#xD;
          -  John Mongan, MD, PhD (University of California San Francisco)&#xD;
  &#xD;
          -  Seong Ho Park, MD, PhD (University of Ulsan College of Medicine)&#xD;
  &#xD;
          -  Ali S. Tejani, MD (University of Texas Southwestern Medical School)&#xD;
  &#xD;
        (*) Survey administrator&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Revise the Checklist for AI in Medicine Imaging (CLAIM) guideline</measure>
      <time_frame>6 months</time_frame>
      <description>potential revision of the CLAIM guidelines through Delphi consensus process.</description>
    </primary_outcome>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Artificial Intelligence</condition>
    <condition>Machine Learning</condition>
    <condition>Diagnostic Imaging</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Physicians, AI researchers and journal editors&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  More than 70 invited panelists -- physicians, AI researchers, and journal editors --&#xD;
               have agreed to participate in the surveys. Those who participate in all rounds of the&#xD;
               survey will be named as contributors in any resulting publications&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non physicians, AI researchers and journal editors&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Charles E. Kahn, Jr., MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hospital of the University of Pennsylvania</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
      <investigator_full_name>Charles E. Kahn, Jr., MD, MS</investigator_full_name>
      <investigator_title>Professor and Vice Chair of Radiology</investigator_title>
    </responsible_party>
    <keyword>Checklist for AI in Medical Imaging (CLAIM)</keyword>
    <keyword>Reporting guideline</keyword>
    <keyword>Delphi consensus method</keyword>
    <keyword>Survey</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05984082
  org study id: 853845
  nct id: NCT05984082
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators will revise the Checklist for AI in Medical Imaging (CLAIM) guideline using
        Delphi consensus methods. An international panel of physicians, researchers, and journal
        editors with expertise in AI in medical imaging -- including radiology, pathology,
        dermatology, GI endoscopy, and ophthalmology -- will complete up to 3 web-based surveys.
        Participants who complete all survey rounds will be credited as contributors on resulting
        publications.
  The survey will be administered in collaboration with:
  
          -  Anthony A. Gatti, PhD (Stanford University)
  
          -  Michail E. Klontzas, MD, PhD (University of Crete School of Medicine) *
  
          -  Linda Moy, MD (New York University Grossman School of Medicine)
  
          -  John Mongan, MD, PhD (University of California San Francisco)
  
          -  Seong Ho Park, MD, PhD (University of Ulsan College of Medicine)
  
          -  Ali S. Tejani, MD (University of Texas Southwestern Medical School)
  
        (*) Survey administrator
  observational model: Other
  time perspective: Prospective
  measure: Revise the Checklist for AI in Medicine Imaging (CLAIM) guideline
  time frame: 6 months
  description: potential revision of the CLAIM guidelines through Delphi consensus process.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 89 Years
  last name: Charles E. Kahn, Jr., MD, MS
  role: Principal Investigator
  affiliation: University of Pennsylvania
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Pennsylvania
  investigator full name: Charles E. Kahn, Jr., MD, MS
  investigator title: Professor and Vice Chair of Radiology