<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF8166-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort on Iatrogenic Risks Associated with CT Scans Received in Childhood</titl>
      <IDNo>FRESH-PEF8166-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Carole RUBINO</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort on Iatrogenic Risks Associated with CT Scans Received in Childhood            </titl>
      <altTitl>
                    TOMENF2                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF8166-en            </IDNo>
      <IDNo agency="PEF">
                    8166                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF8166                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Carole RUBINO                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)">
        <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
        <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            EUROPEAN COMMISSION RESEARCH                    
                                    </fundAg>
      <fundAg>
                                            ELECTRICITE DE FRANCE (EDF)                    
                                    </fundAg>
      <fundAg>
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="carole.rubino@gustaveroussy.fr">
                    Carole;RUBINO
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Tomography</keyword>
      <keyword vocab="" vocabURI="">
                    dose-effect relationship</keyword>
      <keyword vocab="" vocabURI="">
                    CT scan</keyword>
      <keyword vocab="" vocabURI="">
                    ionising radiation</keyword>
      <keyword vocab="" vocabURI="">
                    iatrogenic effects</keyword>
      <keyword vocab="" vocabURI="">
                    dosimetry</keyword>
      <topcClas vocab="health theme">
                        Neurology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009462"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Ophthalmology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/621ef1ce-2ebd-43d9-a6c7-ecd962d27269"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009885"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Oncology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D008495"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Cardiology and vascular medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/4455c187-2f2f-4cd1-a4dd-449f59d73b39"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D002309"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Malignant neoplasms of ill-defined or unspecified primary sites                                            </topcClas>
      <topcClas vocab="cim-11">
                        Cerebrovascular diseases                                            </topcClas>
      <topcClas vocab="cim-11">
                        Diseases of the circulatory system                                            </topcClas>
      <topcClas vocab="cim-11">
                        Cataract                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">The objective is to form a multicentric cohort of 30,000 children admitted to radiology departments in France in order to describe the pattern of computerised tomography use during childhood and to estimate the dosage associated with these examinations. This cohort will later explore the iatrogenic effects of low-dosage of ionising radiation, carcinogenic and non-carcinogenic effects.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Child, Preschool (2 to 5 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002675"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe clusion="I">Children under 15 years old admitted to radiology services for initial examination after 1st January 2000 - Children permanently living in France - not diagnosed with cancer during first year after computerised tomography (CT) scan.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[10000-20000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>30 000</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the principal investigator</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
