The ALCOA principles outline requirements for records integrity and commonly used in pharmaceutical and clinical research. Adherence to these principles is a part of ensuring the reliability and integrity of research data, thereby supporting the validity of study results.
ALCOA principles
A number of attributes are considered of universal importance to data [1].
Original principles
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
+ principles
- Complete
- Consistent
- Enduring
- Available when needed
++ principle
- Traceable
See also
Another relevant pages
Links to this page
- ALCOA+CCEA (redirect page) (← links)
- ALCOA-C Principles (redirect page) (← links)
- Source data (← links)
- Source documents (← links)
References
- ↑ EMA, 2023, EMA/INS/GCP/112288/2023 Guideline on computerised systems and electronic data in clinical trials https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf Accessed May 2024
External links