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 Scientists Examining Data GettyImages-1346675624](https://vertassets.blob.core.windows.net/image/8706d4b6/8706d4b6-f6d9-456e-8902-8e5ca5065564/375_250-scientists_examining_data_gettyimages_1346675624.jpg)
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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