ALCOA principles

ALCOA is an acronym describing the fundamental attributes expected of data and records throughout their lifecycle. The principles are widely used in pharmaceutical manufacturing, laboratory practice, and clinical research to evaluate data integrity and documentation practices.

The original ALCOA principles were later expanded to include additional attributes. The extended framework is commonly referred to as ALCOA+, while some organizations also recognize a further extension known as ALCOA++.

Definition

Original ALCOA principles

The acronym ALCOA represents five original principles 1 describing attributes considered of universal importance to data 2:

  1. Attributable – the person who created, modified, or reviewed a record can be identified
  2. Legible – the record remains readable and permanent throughout its retention period
  3. Contemporaneous – information is recorded at the time the activity is performed or observed
  4. Original – the record is the first capture of the data or a verified true copy that preserves the original content
  5. Accurate – the record correctly reflects the observed data without errors or unauthorized modification

ALCOA+

The ALCOA framework was subsequently expanded with four additional principles:

  1. Complete – all relevant data, including repeat measurements, amendments, and audit trails where applicable, are retained
  2. Consistent – records are presented in the correct chronological sequence and remain internally coherent
  3. Enduring – records are maintained in a durable medium throughout the required retention period
  4. Available – records can be retrieved for review, audit, or inspection when required

ALCOA++

Some organizations additionally include a tenth principle:

  1. Traceable – the history of data creation, modification, and processing can be reconstructed from the available records and metadata.

The term ALCOA++ is not defined by a single regulatory authority, and the additional principle may vary between organizations and guidance documents.

Use in clinical research

In clinical research, the ALCOA principles are applied to source documents, case report forms (CRFs), electronic records, laboratory data, and other study documentation. The principles are commonly referenced in discussions of data integrity, good clinical practice (GCP), and computerized systems used in clinical trials.

Related terminology

  • Audit trail
  • Data integrity
  • Source data
  • Source document
  • Good clinical practice (GCP)

References

  1. U.S. Food and Drug Administration. 2018. Data Integrity and Compliance With Drug CGMP: Questions and Answers. Guidance for Industry.
    Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers ↩︎
  2. European Medicines Agency. 2023. EMA/INS/GCP/112288/2023 Guideline on Computerised Systems and Electronic Data in Clinical Trials.
    Available at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf ↩︎