Assessing the potential impact of ICH E6 R3 on Electronic Health Records August 2023
Assessing the potential impact of ICH E6 R3 on Electronic Health Records (EHRs). Help is available! Section 4.3 of the draft guidance indicates that the sponsor should review whether the systems used by the investigator/institution (e.g., electronic health records and other record keeping systems for source data collection) are fit for purpose in the context [...]