Avid Bioservices Inc (CDMO)

[learningcurve2020]

On performing Source Document Verification
The implications of not performing SDV must also be understood. A relatively small
amount of information is collected during clinical trials, which can subsequently result
in massive patient exposure if the drug is process marketed. There is danger of collecting inac-
curate or invalid data from which false or inappropriate conclusions can be drawn. The
rejection of clinical trial data by regulatory authorities can lead to refusal to grant a mar-
keting license and this can have severe time and financial penalties for the company.

These guidelines further state that the
monitor should maintain a record of the findings, conclusions, and action taken to correct
deficiencies for each on-site visit to an investigator. Such a record can enable FDA to
determine that a sponsor ’s obligations in monitoring the progress of a clinical investi-
gation are being fulfilled. The requirement to examine source documents is clearly stated.