Electronic Health Records can either be scanned paper records or direct data entry/source data capture. However, it make no diference how the data is collected in terms of the expectations of GCP. The sponsor is responsible for identifying where the source data is captured and how they will perform source data verification. If the source data is electronic, then there must be provisions with the site about how the sponsor will access this data. This can either be by direct access, or as a certified paper copy. If it is the later the sponsor is responsible for verifying this a robust process to ensure the certified copies are complete and reliable. It is recommended you refer to the EMA reflection paper EMA/INS/GCP/454280/2010.