EMA: Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials

The scope of this reflection paper is electronic systems, (including instruments, software and services) used in clinical trials in the creation/capture of electronic clinical data, such as: Electronic Case Report Forms (e-CRFs) e.g. laptop/desktop, mobile device based programs or web based tools, which may contain source data directly entered, transcribed data by re-keying from other sources, or both. Electronic patient data capture devices used to collect Patient Reported Outcome (PRO) data– e.g. mobile devices supplied to patients to record observations, rating scales, IMP use. This can be primary efficacy or supportive data. Instruments supplied to investigators for recording clinical data either by data entry or by automated capture of events such as biometric measures (e.g. blood pressure, respiratory measures, ECG monitoring etc). Instrumentation or electronic systems to capture, generate, manipulate or store data in an environment where analysis, tests, scans, imaging, evaluations, etc. are performed in support of clinical trials. Electronic Health Records.