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  • 11 Down Project Index Page Format PDF

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    Edwin Martin
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    The document outlines a standard format for a project index page, including sections for the project title, an index of required documents specifying page numbers and person initialing checks, and a mandatory project completion letter. The index includes documents like a project summary, research protocol, informed consent forms, and additional documents that may be required depending on the project type such as an investigator brochure or approval letters from regulatory bodies.

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    11_Down_Project_Index_page_Format.pdf

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    The document outlines a standard format for a project index page, including sections for the project title, an index of required documents specifying page numbers and person initialing checks, and a mandatory project completion letter. The index includes documents like a project summary, research protocol, informed consent forms, and additional documents that may be required depending on the project type such as an investigator brochure or approval letters from regulatory bodies.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    806 views2 pages

    11 Down Project Index Page Format PDF

    Uploaded by

    Edwin Martin
    The document outlines a standard format for a project index page, including sections for the project title, an index of required documents specifying page numbers and person initialing checks, and a mandatory project completion letter. The index includes documents like a project summary, research protocol, informed consent forms, and additional documents that may be required depending on the project type such as an investigator brochure or approval letters from regulatory bodies.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 2

    Project Index page Format

    A. Project Index Page Format

    Project Index Page

    Project Title

    Index

    No Document Name Page PI Check


    ( Please specify in “Page Nos” column NA if not applicable ) Nos. Chk ( SRS
    use )
    1. Research Project Format *
    a. Project Summary *
    b. Research Protocol Application Format *
    c. References *
    d. Patient Information Sheet in 3 languages *
    e. Patient Informed Consent Form in 3 languages *
    f. Case Record Form / Questionairre / Patient Diary *
    2. Additional Documents ( As may be required )
    a. Investigator Brochure for Sponsored project
    b. Clinical Trial Agreement
    c. Insurance Policy with suitable validity
    d. DGCI Approval Letter for Phase I/ II/ III study
    e. Investigator’s undertaking to DCGI for Phase I II III
    studies
    f. Ethics Committee Clearance status  Multicentric 
    Multinational study only  Letter from Ethics Committee 
    Letter from Sponsor for status
    g. Food and Drug Administration FDA
    marketingmanufacturing license for herbal drugs(
    h. Please specify if Clearance of other Bodies as may be
    required  Sample List enclosed below 
    3. Project Completion Letter *
    • * Mandatory

    **
    Health Ministry Screening Committee HMSC 
    • Bhabha Atomic Research Centre BARC 
    • Genetic Engineering Advisory Committee GEAC 
    • Director General of Foreign Trade DGFT
    • Etc$

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