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  • 11 Down Project Index Page Format

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    dinesh singh
    32 views2 pages
    The document outlines the format for a project index page, including sections for the project title, index of documents with page numbers, and signatures from the principal investigator and reviewers. It lists mandatory sections like the project summary, research protocol, and references. It also lists additional documents that may be required depending on the project type, such as an investigator brochure, clinical trial agreement, ethics committee approval, and project completion letter.

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    SEFERTYERHGTRHFGHYJYTJUYUUJJ

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    The document outlines the format for a project index page, including sections for the project title, index of documents with page numbers, and signatures from the principal investigator and reviewers. It lists mandatory sections like the project summary, research protocol, and references. It also lists additional documents that may be required depending on the project type, such as an investigator brochure, clinical trial agreement, ethics committee approval, and project completion letter.

    Copyright:

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

    11 Down Project Index Page Format

    Uploaded by

    dinesh singh
    The document outlines the format for a project index page, including sections for the project title, index of documents with page numbers, and signatures from the principal investigator and reviewers. It lists mandatory sections like the project summary, research protocol, and references. It also lists additional documents that may be required depending on the project type, such as an investigator brochure, clinical trial agreement, ethics committee approval, and project completion letter.

    Copyright:

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

    Project Index page Format

    A. Project Index Page Format


    Project Index Page
    Project Title

    Index
    No Document Name
    ( Please specify in Page Nos column NA if not applicable )
    1.

    2.

    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 *
    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. Investigators 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 

    Page
    Nos.

    PI
    Chk

    Check
    ( SRS
    use )

    Genetic Engineering Advisory Committee GEAC 

    Director General of Foreign Trade DGFT

    Etc$

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