Article | October 24, 2022

How Paper And Electronic Source Data Meet ALCOA-C Principles

Source: Advarra

By Shannon Roznoski, CCDM, CCRP, Director of Product Management

Scientists Examining Data GettyImages-1346675624

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? 

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