By Shannon Roznoski, CCDM, CCRP, Director of Product Management
According to the Food and Drug Administration (FDA), data should meet certain fundamental elements of quality. Whether they’re recorded on paper or electronically, source data should follow ALCOA-C, an acronym used in clinical research for:
If these best practices for source documentation aren’t followed, there is no valid evidence the test article is safe and effective.
What does each element of ALCOA-C mean, and how are the principals implemented differently for data originally collected on paper versus first recorded electronically?