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  • Cover Letter - PD Log Submission January - Oct 2014 - 1245.25 - 62002

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    1) The document is a letter from Dr. Dante Saksono Harbuwono as the Principal Investigator to Prof. Dr. dr. Rianto Setiabudi as the Chair of the Ethics Committee of the Faculty of Medicine at the University of Indonesia. 2) It includes an attached protocol deviation log from a clinical trial conducted from January to October 2014 on a drug to treat type 2 diabetes. 3) The letter is to inform the committee chair about the protocol deviations that occurred during monitoring visits for the clinical trial over that time period and offers to provide any additional information if needed.

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    Cover Letter_PD Log Submission January- Oct 2014_1245.25_62002

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    1) The document is a letter from Dr. Dante Saksono Harbuwono as the Principal Investigator to Prof. Dr. dr. Rianto Setiabudi as the Chair of the Ethics Committee of the Faculty of Medicine at the University of Indonesia. 2) It includes an attached protocol deviation log from a clinical trial conducted from January to October 2014 on a drug to treat type 2 diabetes. 3) The letter is to inform the committee chair about the protocol deviations that occurred during monitoring visits for the clinical trial over that time period and offers to provide any additional information if needed.

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    6 views1 page

    Cover Letter - PD Log Submission January - Oct 2014 - 1245.25 - 62002

    Uploaded by

    scribd
    1) The document is a letter from Dr. Dante Saksono Harbuwono as the Principal Investigator to Prof. Dr. dr. Rianto Setiabudi as the Chair of the Ethics Committee of the Faculty of Medicine at the University of Indonesia. 2) It includes an attached protocol deviation log from a clinical trial conducted from January to October 2014 on a drug to treat type 2 diabetes. 3) The letter is to inform the committee chair about the protocol deviations that occurred during monitoring visits for the clinical trial over that time period and offers to provide any additional information if needed.

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    © All Rights Reserved
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    Jakarta, 24 Oktober 2014

    No: XXX
    Kepada YTH:
    Prof. Dr. dr. Rianto Setiabudi, SpFK
    Ketua Komite Etik Fakultas Kedokteran Universitas Indonesia
    Jalan Salemba Raya no. 6
    Jakarta, 10430 Indonesia.
    Protocol Number & Study Title:
    BI10773
    A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular
    safety study of BI 10773 (10mg and 25mg administered orally once daily) compared to usual
    care in type 2 diabetes mellitus patients with increased cardiovascular risk
    Re: Submissi Protocol Deviation log January 2014-October 2014

    Dengan Hormat,
    Mohon melihat terlampir untuk protocol deviation log berdasarkan monitoring visit yang telah
    dilakukan dari January 2014-October 2014.
    Terima kasih atas perhatiannya jika ada pertanyaan mengenai ini mohon menghubungi saya.

    (_____________________)
    dr. Dante Saksono Harbuwono, SpPD-KEMD, PhD.
    Principal Investigator

    I acknowledged the receipt of the above mentioned document


    Name:

    Signature:

    Date:

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