I agree with you Margit. Unfortunately, the advice from regulators is not always so consistent or clear. For example, it appears to be acceptable for there not to be certification if the original is still in existence and is accessible for potential inspection if the scenario relates to the investigational site or another third party (i.e. sponsor holds copy and original exists at the site or a lab or some other location). However, if the sponsor holds a copy in their electronic trial master file (eTMF) and the original is still in existence and available for potential inspection but is held in the sponsor's archives, some regulators are insisting on the copy in the eTMF being certified. To my mind, this sounds like double-standards and lacking logic. If the original exists for verification (if needed) then it shouldn't matter if the original is held by the sponsor or a third party. In fact, there is an argument to say that certification would be more helpful in the cases where the site holds the original, to avoid having to make a separate inspection for verification purposes (the sponsor original being more accessible during a sponsor inspection).
Eldin.