Home › Forums › Where do I file…. ? › TMF RM_EU Clinical Trials Regulation 536/2014 › Reply To: TMF RM_EU Clinical Trials Regulation 536/2014
Hello, we have not yet addressed this to be honest. It’s six of one, half a dozen of the other – there’s no right answer, only the one that best suits the kind of TMF system you have, the filing responsibilities in your company, and other factors. In our case (this is a personal opinion again we have not discussed in my company) I might be tempted to file it both Zones 03 and 04, so that our automatic completeness tracking tool is accurate. Yes, it is technically content duplication, but for my part, given the limitations of our eTMF system, content duplication if it serves distinct, separate documentation purposes, is acceptable. I am very open to dissenting opinions!