When mobile technology is used in a clinical investigation to capture, record, and
transmit study-related data directly from study participants, the data are collected and
stored, perhaps for very short periods of time on the mobile technology before being
transmitted to the sponsor’s EDC system. In some cases, the data may pass temporarily
through various electronic hubs or gateways before reaching the sponsor’s EDC system.
This could make the location of the source data difficult to determine.
FDA considers source data as data that are first recorded in a permanent manner. In
general, for data collected directly from study participants through mobile technology,
the first permanent record is located in the sponsor’s EDC system or the EHR, and not in
the mobile technology. FDA does not intend to inspect each individual mobile
technology used in a clinical investigation to capture, record, and transmit data directly
from study participants because access controls (see section IV.D.Q17), audit trails (see
section IV.D.Q20), and validation (see section IV.D.Q21) that would be applied would
help ensure the reliability of the data.
