The investigator should ensure integrity of the data under their responsibility whatever the media. Source records should hold the pertinent observations on each participant and meet the ALCOA+ expectations (attributable, legible, contemporaneous, original, accurate, complete), with changes traceable, not obscuring the original and explained where needed (for example by audit trail); before the trial the investigator should define what the source records are, the capture methods and their location, update this when needed and avoid unnecessary transcription. With timely access provided by the sponsor, the investigator should review data promptly, including external data affecting eligibility, treatment or safety (central laboratory, central imaging, other institutions' records, ePRO where appropriate), use sponsor data tools as specified, make sure data reported in CRFs and other reports such as SAE reports are accurate, complete, legible and timely, endorse them at agreed milestones, keep reported data consistent with source or explain discrepancies with traceable corrections, protect participants' personal information, and identify reported data by an unambiguous code traceable to the participant only by the site.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.