What are the ALCOA++ principles?

The ALCOA++ principles are quality guidelines for documentation in regulated areas of clinical trials.

"ALCOA++" stands for:

1. Attributable (traceable): All documentation should be traceable to an identifiable person. It must be clear who is responsible for the creation and modification of records.
2. Legible: All records should be legible and understandable. Illegible or unclear documentation can lead to misinterpretation and problems.
3. Contemporaneous: Documentation should be created in a timely manner, i.e. at the moment the related activities take place. Delays could affect the accuracy and integrity of the data.
4. Original (original): The documentation should be the original and not copies or duplicates. Originals are less susceptible to tampering and provide a reliable source of information.
5. Accurate: Documentation should be correct and accurate. Incorrect records could lead to false conclusions and uncertainties regarding the quality of the activities performed.
6. Complete: All relevant information should be included in the records. Incomplete records could lead to information gaps that affect the validity of the data collected.

The additional "+" in ALCOA++ extends these principles:

7. Consistent: Records should be consistent and in accordance with other relevant documents to avoid inconsistencies.
8. Enduring: Records should be permanent and readable and available throughout their lifecycle to ensure traceability and integrity.

These principles must of course also be carefully implemented in digital study platform systems.