Scribd Logo
Upload

Welcome to Scribd!

  • 11 views

    4.2. Review of Protocol Amendments

    Uploaded by

    Kusnul Hasanah
    This document outlines the protocol amendment submission form used by the Medical and Health Research Ethics Committee at Universitas Gadjah Mada's Faculty of Medicine. The form requires investigators to provide details of the proposed amendment such as a description of the amendment, the reason for the amendment, any issues with the original protocol, and potential issues of the amended protocol. Investigators must sign and date the form, which is then reviewed by the committee to determine if the amendment requires an expedited minor review or full review.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content

    You might also like

    4.2. Review of Protocol Amendments

    Uploaded by

    Kusnul Hasanah
    11 views1 page
    This document outlines the protocol amendment submission form used by the Medical and Health Research Ethics Committee at Universitas Gadjah Mada's Faculty of Medicine. The form requires investigators to provide details of the proposed amendment such as a description of the amendment, the reason for the amendment, any issues with the original protocol, and potential issues of the amended protocol. Investigators must sign and date the form, which is then reviewed by the committee to determine if the amendment requires an expedited minor review or full review.

    Original Description:

    Original Title

    Amendment

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    This document outlines the protocol amendment submission form used by the Medical and Health Research Ethics Committee at Universitas Gadjah Mada's Faculty of Medicine. The form requires investigators to provide details of the proposed amendment such as a description of the amendment, the reason for the amendment, any issues with the original protocol, and potential issues of the amended protocol. Investigators must sign and date the form, which is then reviewed by the committee to determine if the amendment requires an expedited minor review or full review.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as docx, pdf, or txt
    11 views1 page

    4.2. Review of Protocol Amendments

    Uploaded by

    Kusnul Hasanah
    This document outlines the protocol amendment submission form used by the Medical and Health Research Ethics Committee at Universitas Gadjah Mada's Faculty of Medicine. The form requires investigators to provide details of the proposed amendment such as a description of the amendment, the reason for the amendment, any issues with the original protocol, and potential issues of the amended protocol. Investigators must sign and date the form, which is then reviewed by the committee to determine if the amendment requires an expedited minor review or full review.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as docx, pdf, or txt
    of 1

    Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada 4.2.

    Review of Protocol Amendments

    SOP 4.2-013.2012-02 Effective date: 1 October 2012 Page 1 of 1

    ANNEX 1 AF 4.2.01-013.2012-02 Protocol Amendment Submission Form


    PROTOCOL NUMBER: PROTOCOL TITLE: APPROVED DATE:

    PRINCIPAL INVESTIGATOR: INSTITUTE: Telephone:

    SUBMITTED DATE of AMENDMENT:

    AMENDMENT NO.

    REQUEST FOR AMENDMENT MEMORANDUM (use additional page if necessary): - State/describe the amendment - Provide the reason for the amendment - State any untoward effects with original protocol - State expected untoward effects because of the amendment Note: Changes made to the protocol and protocol-related documents should be clearly marked either with the underlining or highlighting feature of the software package used to prepare the document.

    SIGNATURES: Principal Investigator Date:..

    Decision for Review type: EXPEDITED (Minor changes)

    FULL REVIEWED Date: ...

    Secretary, MHREC FM UGM

    You might also like