My question is around the storage of final patient data reports (PDRs) that are exported out of an EDC system. Obviously, these are sent to the sites with acknowledgement of receipt. We also archive these on a separate archival server. The final PDRs for submission studies are stored in our Regulatory Submission repository. My question for the group, does anyone actually file the final PDRs in your eTMF system, ie. XXX or XXX? We have taken the stance that since they contain patient data that they should not be filed in the eTMF system. Wonder if there are any regulations around this and how others in the TMF industry are handling this data? Thanks in advance. Laura
So per ICH GCP, patient data collected via an EDC system is part of the TMF. However, there is no requirement to manage all TMF components in a single system, especially when the primary system might not be suitable for managing data sets.
You should therefore manage the data sets in a system where they can be retrieved easily for business purposes (trial conduct) but also for potential inspection. This is still part of your TMF but may not be your primary eTMF. Most sponsors do not manage these data sets in their primary eTMF, which are usually best suited to documents.
There are no regulations that would prevent you storing EDC data sets in an eTMF (since they are part of the TMF) but you need to be sure there is appropriate roles / permissions and security model to restrict access appropriately. Actually, this would apply to any TMF content…. the security model should restrict access only to those with appropriate authorization.