Jennifer Huddleston

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  • in reply to: Certificates of translations #3021
    Jennifer Huddleston

    Hi all,

    I filed these documents as a ‘package PDF’ like:
    Russian ICF v 2.0 20200311
    Russian ICF v 2.0 20200311 – RUS-ENG translation 20200314
    Russian ICF v 2.0 20200311 – ENG-RUS backtranslation 20200314
    Russian ICF v 2.0 20200311 – Translation Certificate 20200314
    Russian ICF v 2.0 20200311 – QA or Cert of Translation 20200314

    For some trials, I put a coloured piece of paper between each of the documents to make it easier to navigate.

    in reply to: Correspondence #3020
    Jennifer Huddleston

    Hi everyone, when I was responsible TMF best practices within my organisation, I recommended that the Relevant Communications sections are considered last. Those a valuable sections, no doubt – but I wanted to avoid them becoming a dumping ground… Essentially, I asked everyone to consider where an Inspector would logically expect to see information to put the story together with the least amount of friction.

    If the email was an approval for a block of extra visits to be performed outside what was specified in the Monitoring Plan, then I might file that email with the Monitoring Plans.

    If the email is approval to suspend weekly status meetings and other activities described in the Scope of Work because a trial was delayed – perhaps that would be filed with the Scope of Work document.

    If the email has been sent as a status update to replace a meeting, due to significant staff travel or conflicts, then I might file that email with the other meeting minutes for that meeting type.

    If, after I have considered all other viable options, the email doesn’t seem to fit well in any non-Relevant Correspondence section, but it still feels like an auditable artifact then I file it in the most fitting one. However, I also asked my team to consider whether there is any other artifact better placed to capture the information. For example, if I have wads of emails providing comments on the protocol during a review cycle then I would prefer filing the collated review comments in a single document in the appropriate section – provided it still meets the necessary ALCOA requirements!

    Basically, I tried to avoid using the Relevant Communications section so that what did end up there actually belonged!

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