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One more point – if you do keep these in your eTMF, there probably needs to be a way to restrict access to people with a “need to know” – as financial information is often considered sensitive and access may be limited to a subset of eTMF users.
Hi Brad,
I would appreciate the opinion of others, but I think that many of the document types you mention aren’t literally part of the TMF. For example, if you consult MHRA GCP, p. 333, there is a diagram that shows IMP documentation as part of “Supporting documentation” and not part of the TMF.
That doesn’t mean it’s not inspectable, but that the expectation would not be that it is filed in a TMF structure.
I also see the following in an MHRA presentation on GCP.
•Essential documents (E6 section 8) can reside on a single system, but the MHRA extended expectations include access to material residing on different systems:
–GMP data (e.g. batch records) not needed by clinical staff
–Regulatory documentation (e.g. applications to MHRA)Would be interesting to hear from those with inspection experience on this point.
Kathie
Hi Maria,
It’s good to keep in mind that the goal of naming is to 1) allow a user to find a document quickly by keyword search 2) accurately identify the content of the document and 3) allow a user (including a health authority) to understand what is in a document without having to open it.
Hopefully it is possible for your eTMF to produce automatic names for your documents that include key elements of metadata. I once had someone tell me there were 14 different ways of naming protocols in their organization! Obviously that is not helpful. On the other hand, simply identifying the document as a protocol (or amendment) is probably sufficient in an eTMF as there are not a significant number of these in a given study.
However, there are other cases where document type, site, etc. are not sufficient. For example, when naming IRB submissions and approvals, the system probably does not have enough metadata to assign a unique name. Having a dozen “IRB Submissions” only distinguished by date does not help an inspector know which one to look at.
In this case, there should be a variable part to the title in addition to the standard part. Submitters should be given guidance on what information to include in the variable part to accurately identify the document.