Jenn Leaning

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  • in reply to: PI CV address and 1572 Section 3 address not matching #3624
    Jenn Leaning
    Participant

    Hi Daniella,

    I think it would depend on which address is correct? Or does the address on the CV at least match the address under Section 1?

    The FDA guidelines state that there are two instances when it is necessary for an investigator to complete and sign a new 1572: when an investigator is participating in a new protocol that has been added to the IND and when a new investigator is added to the study (21 CFR 312.53(c)).

    If there are other changes to information contained on a signed and dated 1572 (e.g., an IRB address change, the addition of new sub-Is, the addition of a clinical research lab), the investigator should document the changes in the clinical study records and inform the sponsor of these changes, so that the sponsor can appropriately update the IND. The 1572 itself does not need to be revised and a new 1572 need not be completed and signed by the investigator.

    … With that said, if the address on the CV is incorrect/not up to date, then I feel it would be reasonable to request the PI to update his/her CV to reflect the most current/accurate information for your study files.

    Also just my two cents…If I’m not mistaken, my understanding is that the address in Section 3 doesn’t necessarily have to be the same as the PI’s CV, but the address under Section 1 should match the information on the PI’s CV 🙂

    in reply to: Source Document Worksheets #3545
    Jenn Leaning
    Participant

    Ahh great suggestion! Thank you so much for your input – very helpful 🙂

    in reply to: Filing of final word documents in the TMF #2862
    Jenn Leaning
    Participant

    Hi Caryl,

    In my experience, it is always a safer practice to convert any finalized word documents into a PDF format prior to filing in the TMF. Although technically, PDF documents can be altered/edited too, the possibility of one accidentally editing a .pdf vs .docx is significantly lower. Converting to a PDF will help avoid the risk of accidental/inadvertent edits when opening/closing the document.

    … With that said, of course, I have encountered occasions when a document’s final version is a MS Word file. In those cases, I always sent/kept an e-mail correspondence with the MS Word file attached (with the e-mail content specifically stating that the attached is the finalized/approved version), so that I can trace back when the document was finalized, and in what condition. That e-mail is then filed as a part of the study correspondence… = Audit Trail 🙂

    I think the best practice would be to establish an internal procedure (e.g., SOP/Work Instruction) at the organizational level to specify and implement a documentation practice that suits your business needs. There are some good articles and white papers online surrounding Good Documentation Practices that you may be able to use as a reference too.

    Hope this helps!

    – Jenn.

    in reply to: Filing Site-Specific SOPs #2809
    Jenn Leaning
    Participant

    Hello,

    For our organization, we maintain one TMF “set” per site to maintain site-level documents, so we could technically place the site-specific SOPs within 01.01.04 if the situation arises. Although I do agree with Marie and Darwin that the site should maintain all SOPs internally and not a regulatory requirement for Sponsors/CROs to collect, I have incidences where I’ve received site-specific SOPs before.

    Example being: if the sponsor includes a “regulatory coordinator (not SC)” column in the DOA and requires that everyone on the DOA must have protocol training, but the site pushes back and proclaims that their site SOP specifies that regulatory coordinators are not required to receive protocol training, then we would request a copy of that SOP (or its section) so in the case the Sponsor gets audited, we have sufficient documentation to explain the reasons why.

    But, it does make me wonder (for the situation I noted above): If an organization (Sponsor) does not collect site-specific SOPs for the TMF:
    instead of requesting a copy of the site’s SOP, would it be better to have the site provide a memo for our records, or is it sufficient to have the CRA note in a MV Report the SOP# and reasons?

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