Regulatory Open Forum

 View Only

  • 1.  eCTD and paper CRFs

    Posted 11-Mar-2014 13:27
    When completing an eCTD where the data was collected on paper CRFs, is it required to submit the actual paper CRFs or just the clinical datasets?

    I would appreciate your answers.

    Thank you.

    -------------------------------------------
    Dawn Edgerton RAC
    Rho, Inc.
    Chapel Hill NC
    United States
    -------------------------------------------


  • 2.  RE:eCTD and paper CRFs

    Posted 11-Mar-2014 15:59
    Case report forms 

    You should provide an individual subject's complete CRF as a single PDF file. If a paper CRF 
    was used in the clinical trial, the electronic CRF should be a scanned image of the paper CRF 
    including all original entries with all modifications, addenda, corrections, comments, 
    annotations, and any extemporaneous additions. If electronic data capture was used in the 
    clinical trial, you should submit a PDF-generated form or other PDF representation of the 
    information (e.g., subject profile). 

    -------------------------------------------
    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
    -------------------------------------------






    Original Message


  • 3.  RE:eCTD and paper CRFs

    Posted 12-Mar-2014 02:43
    Dawn,

    I presume you have asked for US submissions and yes, as Chang said, you should be scanning the paper CRFs to PDF and submit it for each individual case. The scanned CRFs along with the datasets, listings, programs, analyses, annotated etc., should all be included in the same respective STFs, where you have placed the respective study report and given the appropriate file tags for better viewability by the reviewer. FDA doesn't recommend the 5.3.7 section for CRF use.

    And also CRFs are the requirement only for US submissions and is not recommended to be submitted for EU and I am not sure about other regions.

    Best Luck.

    -------------------------------------------
    Venkatesh Rao
    India
    -------------------------------------------






    Original Message


  • 4.  RE:eCTD and paper CRFs

    Posted 12-Mar-2014 12:27
    Dawn,

    Refer to the Guidance for Industry Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and Related Submissions using eCTD Specifications, Page 15. I have provided the text for ease of review.

    Case report forms 
    You should provide an individual subject's complete CRF as a single PDF file. If a paper CRF 
    was used in the clinical trial, the electronic CRF should be a scanned image of the paper CRF 
    including all original entries with all modifications, addenda, corrections, comments, 
    annotations, and any extemporaneous additions. If electronic data capture was used in the 
    clinical trial, you should submit a PDF-generated form or other PDF representation of the 
    information (e.g., subject profile). 
    You should use the subject's unique identifier as the title of the document and the file name. 
    These names are used to assist reviewers in finding the CRF for an individual subject. Each CRF 
    must have bookmarks as part of the comprehensive table of contents required under 
    21 CFR 314.50(b). We recommend bookmarks for each CRF domain and study visit to help the 
    reviewer navigate the CRFs. For addenda and corrections, making a hypertext link from the 
    amended item to the corrected page or addendum is a useful way to avoid confusion. Bookmarks 
    for these items should be displayed at the bottom of the hierarchy.

    All the best,

    Dar

    -------------------------------------------
    Darlene Rosario
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
    -------------------------------------------






    Original Message