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  • BI - Cover Letter Template For EC Submission - Sent 03 Dec 2014

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    1) The principal investigator notifies the chairman of the ethics committee of safety letters regarding a phase III clinical trial of a diabetes medication called BI 10773. 2) Three adverse events are reported: syncope that was recovered, benign prostatic hyperplasia that was recovered, and locally advanced pancreatic carcinoma that was not yet recovered. 3) The principal investigator provides contact information and requests acknowledgment of receipt of the safety documents.

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    BI_Cover Letter Template for EC Submission_sent 03 Dec 2014

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    1) The principal investigator notifies the chairman of the ethics committee of safety letters regarding a phase III clinical trial of a diabetes medication called BI 10773. 2) Three adverse events are reported: syncope that was recovered, benign prostatic hyperplasia that was recovered, and locally advanced pancreatic carcinoma that was not yet recovered. 3) The principal investigator provides contact information and requests acknowledgment of receipt of the safety documents.

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    © All Rights Reserved
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    1 views2 pages

    BI - Cover Letter Template For EC Submission - Sent 03 Dec 2014

    Uploaded by

    scribd
    1) The principal investigator notifies the chairman of the ethics committee of safety letters regarding a phase III clinical trial of a diabetes medication called BI 10773. 2) Three adverse events are reported: syncope that was recovered, benign prostatic hyperplasia that was recovered, and locally advanced pancreatic carcinoma that was not yet recovered. 3) The principal investigator provides contact information and requests acknowledgment of receipt of the safety documents.

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    of 2

    PLEASE PRINT THE LETTER IN AN INSTITUTION LETTER HEAD

    Jakarta,
    ..December 2014
    No. of Letter: <Departments reference number for correspondence>
    To:
    <Name of the Chairman of Ethics Committee>
    The Chairman of <Name of Ethics Committee>
    <Address of Ethics Committee line1>
    <Address of Ethics Committee line2>
    Protocol No: 1245.25
    A Phase III, multicentre, international, randomised, parallel group, double blind
    cardiovascular safety study of BI 10773 ( 10 mg and 25 mg administered orally
    once daily ) compared to usual care in type 2 diabetes mellitus patients with
    increased cardiovascular risk
    RE: Notification of Safety letters
    Dear <Name of the Chairman of Ethics Committee>,
    In accordance with Good Clinical Practice, I am pleased to submit the following
    safety documents of the above mentioned study for your notification. Please find
    enclosed the the CIOMS

    Substance: BI 10773
    Manufacturer
    Events
    Report #
    SYNCOPE (Syncope) [v.17.1] - Recovered
    BENIGN PROSTAT HYPERTROPHY
    2013-BI-10691BI(7)
    (Benign prostatic hyperplasia) [v.17.1] Recovered
    LOCALLY ADVANCED PANCREATIC
    2014-BI-51815BI(1) CARCINOMA (Pancreatic carcinoma
    metastatic) [v.17.1] - Not Yet Recovered

    Date received by
    Manufacturer
    18-Nov-2014

    20-Nov-2014

    Should you wish further information of any clarification, I am available at any time
    to suit your convenience.
    Thank you very much for your attention to this study.
    Sincerely,
    (________________________________)
    <Name of Principal Investigator>
    Principal Investigator
    Please sign and date below to acknowledge your receipt of the above mentioned
    study documents.

    Name:
    Signature:

    Date:

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