Scribd Logo
Upload

Welcome to Scribd!

  • 12 Down Project Index Page Format

    Uploaded by

    Namrata Das
    2K views1 page
    This document outlines the format for a project index page, including: 1. The project title is listed at the top of the page. 2. The index includes the name and page number or status of required documents for the research project, including a project summary, research protocol, references, patient information materials, case report forms, and additional documents depending on the project type. 3. The project index page must also include a project completion letter to confirm the conclusion of the work. Certain documents marked with an asterisk are mandatory for inclusion.

    Original Description:

    Original Title

    12_Down_Project_Index_page_Format.docx

    Copyright

    © © All Rights Reserved

    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 format for a project index page, including: 1. The project title is listed at the top of the page. 2. The index includes the name and page number or status of required documents for the research project, including a project summary, research protocol, references, patient information materials, case report forms, and additional documents depending on the project type. 3. The project index page must also include a project completion letter to confirm the conclusion of the work. Certain documents marked with an asterisk are mandatory for inclusion.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    2K views1 page

    12 Down Project Index Page Format

    Uploaded by

    Namrata Das
    This document outlines the format for a project index page, including: 1. The project title is listed at the top of the page. 2. The index includes the name and page number or status of required documents for the research project, including a project summary, research protocol, references, patient information materials, case report forms, and additional documents depending on the project type. 3. The project index page must also include a project completion letter to confirm the conclusion of the work. Certain documents marked with an asterisk are mandatory for inclusion.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    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)
    marketing/manufacturing 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.

    You might also like