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. The
sponsor’s EDC system should capture the date and time that the data enter the EDC
system and identification of the data originator (i.e., study participant, mobile technology,
or EHR). In addition, the date and time that the measurement was made should be
recorded and available to FDA at the time of inspection if it differs from the date and
time the data enter the EDC system.
In cases where the study participant actively participates in the performance measure and
manually enters the data into the mobile platform (e.g., tablet computers, smart phones)
or other portable device, the mobile technology should be designed to prevent
unauthorized modifications to the data before those data are transmitted to the sponsor’s
EDC system.
After the data are transmitted to the sponsor’s EDC system, only clinical investigators or
delegated study personnel who are authorized to make changes should perform
modifications or corrections to the data. Modified and corrected data elements should
have data element identifiers that reflect the date, time, and data originator and the reason
for the change. Modified and corrected data should not obscure previous entries.
Clinical investigators should review and electronically sign the completed eCRF for each
study participant before the data are archived or submitted to FDA. Use of electronic
signatures must comply with part 11 (see section V).
