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Thread: Keeping Originals / wet-ink with eTMF.

  1. #1
    Forum Member
    Join Date
    Jul 2014
    New York

    Keeping Originals / wet-ink with eTMF.

    I have to make a company discussion on whether or not to keep original documents and/or wet ink signatures. Following documents are collected as wet ink originals. They were scanned and uploaded in the eTMF . Do we still keep these original wet ink documents ? Concerns include MHRA requirements. Any suggestions will be appreciated.

    1) FDA Form 1572
    2) Protocol and Amendment Signature Pages
    3) Financial Disclosure Forms
    4) Investigator Brochure Acknowledgement Signature Page
    5) Case Report Forms and DCFs.

    Thanks in Advance
    Shah Ashraf

  2. #2
    My understanding is that there is no regulation that MANDATES you have to keep the original records. Thus, your decision is a company one based on several factors that only your company can decide upon. These factors include:

    - do the scanned copies meet the applicable requirements for certified copies? ICH E6(R2) states that copies can only replace originals (i.e. originals destroyed) if the copies are certified copies.
    - do you have QC processes in place that provide assurance of the quality and completeness of scanned documents? Do not destroy originals if the quality of scans is poor.
    - is your eTMF user-friendly i.e. reliable and easy to find documents? If scanned copies cannot easily be located in the eTMF, original hard copies may be requested in an inspection.
    - what is the likelihood of the trustworthiness and provenance of your digitised documents being challenged in court? Scans are usually admissible evidence but as they are not originals, their trustworthiness and provenance may be challenged. Only destroy originals if you can support your scanning process in court.

    If you have satisfactory answers to ALL of the above, there is no reason why you should not destroy originals following scanning. The MHRA have recommended being cautious when choosing to destroy original documents (primarily for the above four reasons) but this is not the same as saying you must not do it.

    Of course, the best option is to change your process to remove the capture of wet-ink signatures. FDA have made available a 1572 template that can be digitally signed. Other documents can be signed electronically via an eTMF application or other means. I wonder why digital signature technology is not more widely used when Return On Investment is typically less than 6 months. We spend millions on clinical trials and clinical trial technology but fail to deploy an advanced electronic signature costing $70 or less. Seems a little bizarre to me :-)

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