What is it? Why is it important?

Data Integrity stands for data accuracy. It is attained through the implementation of ALCOA principles, which ensure that data is:

  • Attributable: tracks who performs when (e.g. date and time) a given task / data point
  • Legible: ensures that data-sets and/or documents are legible
  • Contemporaneously: provides timestamps over when tasks or data points are performed, and when these are modified
  • Original: provides information in its original non-edited form
  • Accurate: provides data free of errors


Additional ALCOA principles include:

  • Complete: generated data is retained in its original form. An audit trail documents any data modifications
  • Consistent: provides consistent data, irrespective of its source of access
  • Enduring: stores data for long periods of time
  • Available: ensures data and long-term stored data is retrievable whenever needed

What do I need to do?

Implement ALCOA principles and operational processes that safeguard Data Integrity. Data Integrity concerns should be addressed over the entire lifecycle of the data, from data collection until analysis or if applicable destruction.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.


ICH GCP E6(R2) – see in particular guideline

  • 4.9.0 Records and Reports
  • ALCOA – Attributable Legible Contemporaneously Original Accurate
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • SBP – Swiss Biobanking Platform
Set-Up ↦ Biobanking ↦ Data Integrity ↦ Data Accuracy

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Set-Up ↦ Biobanking ↦ Data Integrity ↦ Data Accuracy

Please note: the Easy-GCS tool is currently under construction.