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    Biswajit Datta
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    The Institutional Ethics Committee of the Medical College in Kolkata approved a study protocol but with conditions. The committee decided that the researchers must inform them of the study's progress, any serious adverse events, and any changes to the protocol before implementing them. Researchers also must submit a final report in all cases. The committee operates according to ICH-GCP, ICMR, and New Clinical Trial Rules 2019 guidelines.

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    The Institutional Ethics Committee of the Medical College in Kolkata approved a study protocol but with conditions. The committee decided that the researchers must inform them of the study's progress, any serious adverse events, and any changes to the protocol before implementing them. Researchers also must submit a final report in all cases. The committee operates according to ICH-GCP, ICMR, and New Clinical Trial Rules 2019 guidelines.

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    23 views1 page

    Scan 19 Jan 2021

    Uploaded by

    Biswajit Datta
    The Institutional Ethics Committee of the Medical College in Kolkata approved a study protocol but with conditions. The committee decided that the researchers must inform them of the study's progress, any serious adverse events, and any changes to the protocol before implementing them. Researchers also must submit a final report in all cases. The committee operates according to ICH-GCP, ICMR, and New Clinical Trial Rules 2019 guidelines.

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    of 1

    INSTITUTIONAL ETHICS COMMITTEE

    (Reg. No.-ECR/287/Inst/WB/2013/RR-19)
    MEDICAL COLLEGE, KOLKATA
    88, coLLEGE STREET, KOLKATA 700073, WEST BENGAL, IN DIA

    The committee has also decided to:

    Approve the study protocol in the present from.

    DConditionally approve the study protocol subject to..

    Reject the proposal for the following reasons..

    You are required to:

    i) Inform the committee about the progress of the study and compliance of ethical guidelines.
    i) Notify the committee regarding any serious adverse events occurring in the course of the study.
    ii) Inform and seek approval of the committee about any changes in the protocol prior to their
    implementation.
    iv) Submit the final report to the committee in every case.
    v) None of the Study team members including PI were not participated in the voting process.

    This Ethics committee is working in accordance with the ICH-GCP, ICMR and New Clinical Trail
    Rules 2019 guidelines and other applicable regulations as laid down by the DCGI from time to time.

    Yours truly,

    omp 4ml: 13 |v(|204


    Chairperson/Member Secretary IEC
    Medical College, Kolkata

    Page 2 of 2

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