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  • 1245 25 Clinical Tracking Log - Site 62002 - Late Cioms Reporting 9 October 2014

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    There were delays in reporting Indonesian specific safety reports from a clinical trial to the ethics committee between March and October 2014. The reports were not submitted to the ethics committee until October 2014. A clinical research associate will work with the project team and site staff to ensure any serious adverse events are reported on time in the future.

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    1245 25 Clinical Tracking Log_site 62002_late Cioms Reporting 9 October 2014

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    There were delays in reporting Indonesian specific safety reports from a clinical trial to the ethics committee between March and October 2014. The reports were not submitted to the ethics committee until October 2014. A clinical research associate will work with the project team and site staff to ensure any serious adverse events are reported on time in the future.

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    5 views1 page

    1245 25 Clinical Tracking Log - Site 62002 - Late Cioms Reporting 9 October 2014

    Uploaded by

    scribd
    There were delays in reporting Indonesian specific safety reports from a clinical trial to the ethics committee between March and October 2014. The reports were not submitted to the ethics committee until October 2014. A clinical research associate will work with the project team and site staff to ensure any serious adverse events are reported on time in the future.

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    of 1

    Clinical Tracking Log

    Project Number : 1245.25

    30/10/2014

    Protocol Number:

    1245.25

    Sponsor:

    Boehringer Ingelheim

    Investigator Name:

    Harbuwono, Dante Saksono

    Site No.:

    62002

    Date

    Description

    Subject ID
    Initials

    Type

    04:57 PM

    Additional Comments

    ID Number

    09/10/2014

    There were a delay in reporting the Indonesian specific


    CIOMS to the EC since March 2014 and it would only be
    submitted in October 2014. Reference is made to the CIOMs
    cases March - October 2014 which were all reported late to
    the EC.

    26

    The CRA will work together with the project


    team and site staff to ensure the SUSAR
    reporting in on time.

    INVESTIGATOR'S SIGNATURE - I certify that the above information is accurate.

    Investigator Signature

    Date

    Note:26=Non-compliance/consistent data quality issues

    Page 1
    Where Occured Date=2014 OCT 09 and Sponsor Site ID=Harbuwono
    Clinical Tracking Log (2367) - Printed: 30/10/2014 16:57:37:.326

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