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Thread: Site staff CVs in TMF?

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  1. #1
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    Dec 2014
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    Site staff CVs in TMF?

    Requirement of site staff CVs to be filed in TMF?
    As per ICH E6(R2) 8.2.10 we require the CV and/or other relevant documents for evidence of qualification for PIs and Sub Is in both the TMF and ISF.

    The PI has responsibility to ensure his team are adequately trained and hence CVs are filed in the ISF, or the site have their own file of CVs. Historically these CVs are then copied for the TMF. My question is 'is it still an expectation for site staff CVs to be filed in the TMF or just PI and Sub Is?

    It is sufficient that CRAs document the review of the site staff CVs in the ISF but don't file in the TMF?

    Thank you for your advice

  2. #2
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    Difficult to understand.

    See the new EMA final guidance on TMF. It tells you what the TMF is and what should be in it. https://www.ema.europa.eu/en/human-r...-working-group

    TMF consists of both the sponsor TMF and the Investigator TMF (sometimes called the ISF).
    As the TMF must contain "the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated." "TMF documentation should be sufficient to adequately reconstruct the activities undertaken in conducting the trial, along with decisions and justifications made concerning the trial". "Documents and records in the TMF should collectively permit confirmation of compliance with the protocol and GCP and the integrity of data collected without the need for additional explanation from the sponsor, CRO or investigator/institution staff”. Given that the TMF must allow reconstruction of the conduct of the trial and given that ICH GCP requires that "each individual involved in conducting a trial should be qualified by education, training and experience" might follow that it may be wise to document, in the TMF, the CV (etc) of each individual delegated trial related activities. If the documents in the TMF are self explanatory ("without the need for additional explanation from the sponsor, CRO or investigator/institution staff") then you should think about how this information could be readily available and easily accessible to an inspector, during an inspection, of either the investigator and/or sponsor site. Your SOP would be useful in this regard. A risk assessment of whether your TMFs were inspection ready may inform you as to the filing of CVs. I know that the inspectors say that you should avoid duplication, but your risk assessment may decide whether some duplication is warranted to allow each TMF part to be self explanatory ("without the need for additional explanation from the sponsor, CRO or investigator/institution staff")

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