New guidance from the FDA directs clinical investigators on the capture, use, and archiving of electronic data. The document's aim is to ensure that electronic source data are accurate, attributable and contemporaneously entered, and that they meet regulatory requirements for record-keeping and -retention.
Source data from electronic forms of health records, case report forms, lab reports, medical images and patient diaries all have a weakness that paper-based source data doesn't, says FDA: they can be easily copied, transferred, changed, or deleted without obvious evidence. Hence the need for additional safeguards.
FDA divides the guidance in three tiers of data management: Tier 1 is for data entry into an e-CRF, by data originators; tier 2 involves data review, and tier 3 covers data processing and transmission.
The draft guidance suggests that sponsors include in their protocols information about the intended use of computerized systems during a study. Protocols should include a description of the security measures employed to protect data, as well as electronic tools for detecting eCRF data inconsistencies, missing data, and entries out of range. Also suggested: a detailed diagram and description of the transmission of electronic data.
- here's the draft guidance