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  • Dnotes0 - R01 123456 CCSO

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    feb aryanto
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    This document contains 4 sections summarizing clinical study data validation checks across multiple subjects and events. It describes discrepancies including a pulse rate and blood pressure out of the expected ranges and a request to attach a signed consent form. The sections provide details on the study, subject, event, discrepancy type and status, and values needing validation.

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    study for clinica report

    Original Title

    dnotes0_R01-123456-CCSO

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    This document contains 4 sections summarizing clinical study data validation checks across multiple subjects and events. It describes discrepancies including a pulse rate and blood pressure out of the expected ranges and a request to attach a signed consent form. The sections provide details on the study, subject, event, discrepancy type and status, and values needing validation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    9 views4 pages

    Dnotes0 - R01 123456 CCSO

    Uploaded by

    feb aryanto
    This document contains 4 sections summarizing clinical study data validation checks across multiple subjects and events. It describes discrepancies including a pulse rate and blood pressure out of the expected ranges and a request to attach a signed consent form. The sections provide details on the study, subject, event, discrepancy type and status, and values needing validation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    of 4

    Study Identifier: R01-123456-CCSO

    Item field name/value: PULSE = 59

    Study Subject: CAM105 Study Event: Initial


    Treatment

    Study Event Date: 2011-08- CRF: Physical Exam


    01 12:00:00.0 Status: Complete

    Type: Failed Validation Resolution Status: New


    Check

    Number of notes: 2 Discrepancy Note ID: 7

    Days Open: 2431 Days Since Updated: 2431

    Discrepancy note id: 8

    Subject name: CAM105 CRF name: Physical Exam

    Description: Pulse was taken twice Discrepancy note type: Failed


    and was 59 BPM Validation Check

    Event name: Initial Treatment Parent note ID: 7

    Resolution status: New Detailed notes: [Pulse rate ouf of


    expected range of 60-100(must be
    an integer)]

    Entity name: PULSE Entity value: 59

    Date updated: 05-Jul-2011 Study ID: 3


    Study Identifier: R01-123456-CCSO pg.2

    Item field name/value: IFC_PDF

    Study Subject: CAM105 Study Event: Registration


    Visit

    Study Event Date: 2011-07- CRF: Verification of


    06 12:00:00.0 Informed Consent
    Status: Complete

    Type: Query Resolution Status: New

    Number of notes: 2 Discrepancy Note ID: 9

    Days Open: 2431 Days Since Updated: 2431

    Discrepancy note id: 10

    Subject name: CAM105 CRF name: Verification of Informed


    Consent

    Description: Please attach signed Discrepancy note type: Query


    informed consent

    Event name: Registration Visit Parent note ID: 9

    Resolution status: New Detailed notes: This subject has a


    signed paper form on record.
    Please attach

    Entity name: IFC_PDF Entity value:

    Date updated: 05-Jul-2011 Study ID: 3

    Item field name/value: SYSTOLIC = 200


    Study Identifier: R01-123456-CCSO pg.3

    Item field name/value: SYSTOLIC = 200

    Study Subject: SUB001 Study Event: Registration


    Visit

    Study Event Date: 2018-03- CRF: Physical Exam


    05 00:00:00.0 Status: Complete

    Type: Failed Validation Resolution Status: New


    Check

    Number of notes: 2 Discrepancy Note ID: 167

    Days Open: 0 Days Since Updated:

    Discrepancy note id: 168

    Subject name: SUB001 CRF name: Physical Exam

    Description: Actual condition Discrepancy note type: Failed


    Validation Check

    Event name: Registration Visit Parent note ID: 167

    Resolution status: New Detailed notes: [Out of expected


    range.Systolic expected range of
    110-140.]

    Entity name: SYSTOLIC Entity value: 200

    Date updated: 01-Mar-2018 Study ID: 4

    Item field name/value: DIASTOLIC = 110


    Study Identifier: R01-123456-CCSO pg.4

    Item field name/value: DIASTOLIC = 110

    Study Subject: SUB001 Study Event: Registration


    Visit

    Study Event Date: 2018-03- CRF: Physical Exam


    05 00:00:00.0 Status: Complete

    Type: Failed Validation Resolution Status: New


    Check

    Number of notes: 2 Discrepancy Note ID: 169

    Days Open: 0 Days Since Updated:

    Discrepancy note id: 170

    Subject name: SUB001 CRF name: Physical Exam

    Description: Actual condition Discrepancy note type: Failed


    Validation Check

    Event name: Registration Visit Parent note ID: 169

    Resolution status: New Detailed notes: [Out of expected


    range. Diastolic expected range of
    70-90.]

    Entity name: DIASTOLIC Entity value: 110

    Date updated: 01-Mar-2018 Study ID: 4

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