Certified copies and TMF

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    • #3774
      Christina Salinas

      Looking for some input on how other companies certify documents with wet ink signatures. I know that it comes down to how each company defines the process in their SOP, so I’m interested in how other sponsor companies define this task.

      We are in the process of developing an SOP related to this. Currently, we do not require sites to send original wet-ink signatures (FDA Form 1572, PSP, FDF, site visit log, DOA Log, etc.) and we allow sites to maintain all original documents. Our TMF is made up of scanned (PDF) files and indexed in a spreadsheet.

      Thanks in advance for your input.

    • #3775
      Todd Tullis

      I don’t have a sponsor answer for you, but there is a related thread on this topic here, and the final message in that thread from Kathie links to some recent regulatory commentary on use of certified copies.

      Those documents you are getting from the site do not need to be certified as copies, since they are site originals; it is the site’s responsibility to certify the paper as copy if the site decides to destroy the paper.

    • #3780
      Christina Salinas

      Hi Todd,
      Thanks for replying to my question. I reviewed the previous thread and have a follow-up question to your response:

      “Hopefully your eTMF system already has (or can be setup with) a process for a user to upload a scan of a wet-ink document and attest that the scan is an exact copy of the original, with all of the same attributes and information. In this way, your eTMF audit trail captures the relevant information about this important decision.”

      I have not used eTMF systems, therefore can you explain more what you meant by the system has a process for the user to attest that the scan is an exact copy of the original? Typically, what does that process look like? Is there something for the user to check after they have uploaded the document – and then that gets recorded in the audit history? Also, is that only a requirement for documents with wet ink signature?

      If a site does not have a eTMF system set up that way, can you provide some examples of other methods for certifying documents with wet ink signature?

      Thanks again for taking time to respond.

    • #3781
      Todd Tullis

      Hi Christina:

      eTMF systems usually have guided steps for a user to complete a particular process such as certifying a record as a copy. The first minute of this video shows what that process looks like to an end user in one particular site eTMF system (I am not trying to be self-promotional, but linking to this video is much more effective answer than trying to describe it in words here).

      An organization’s SOPs should provide guidance as to when their staff would need to execute such a process (some organizations may not actually destroy certain paper records, thus even if uploaded to a system those records would not need to be certified as copies).

      If an organization does not have an eTMF system or if for some reason a certified PAPER copy of an original paper record needed to be generated, I don’t know of a ‘typical’ approach…but off the top of my head, I could see something like a ‘certified copy attestment’ page being appended to the copy and signed by the person who declared the copy a true reproduction of the original.


    • #3782
      Kathie Clark

      To add a little to what Todd has said… One important thing in certifying copies is that you have to have access to the paper copy! Thus, it is not something that you can usually have a QC person do, as they receive an already-digitized copy in the workflow and usually don’t have access to a paper original.

      Ideally this would be done by the person / function transforming a paper document to an electronic document by scanning or photographing. This may or may not be the person uploading to eTMF.

      That person would certainly need to be trained in what it means to certify the copy (check every page? check for skewing, obscuring, extra pages, ???).

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