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")