When data are copied or transmitted directly from the mobile technology to the sponsor’s
EDC system or from the mobile technology to the EHR and then to the sponsor’s EDC system, the audit trail begins at the time the data enter the sponsor’s EDC system.
These two Q&A are particularly interesting as mobile technology is becoming more and more widely used in clinical investigations to collect patient’s diary data, questionnaires, and daily drug compliance which are often primary or secondary endpoints of a clinical study. It is important to clarify with the sponsor and investigator what is considered source data and include it the clinical protocol.
To summarize, this draft guidance is particularly valuable to sponsors, clinical investigators, contract research organizations, and other interested parties because it provides more direction and detail than a typical FDA guidance, clarifying and expanding its risk-based expectations regarding validation, audit trails, and record archiving.