How Paper And Electronic Source Data Meet ALCOA-C Principles

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: 

• Attributable 
• Legible 
• Contemporaneous 
• Original 
• Accurate 
• Complete 

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?