The United States Food and Drug Administration defines data integrity as “completeness, consistency, and accuracy of data.” Data integrity is critical to regulatory compliance and is, perhaps, the most crucial concept in clinical research. After all, if the data cannot be trusted, then how can you trust the results of the clinical trial?
Data integrity violations result in numerous regulatory actions, such as issuing warning letters and consent decrees. In recent years, the number of FDA warning letters citing data integrity issues have seen an upward trend. In fact, of the data integrity-related warning letters issued since 2008, approximately 80% were issued between 2014 and 2018, indicating that data integrity has become an important point of focus of regulatory inspections.
Breaking down the principles of ALCOA+
According to the FDA data integrity guidelines, data should be Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA). This acronym has been around since the 1990s. The FDA coined it to ensure that data security and integrity are maintained. Over the years, ALCOA evolved into ALCOA+, according to which, in addition to meeting the ALCOA principles, the data should also be Complete, Consistent, Enduring, and Available. These additional principles are particularly pertinent to data management electronic systems.
Let’s break this acronym down and take a look at what each of these principles means:
1. Attributable: This means that the identity of the person who collected the data should be unambiguous. In an electronic source record, the computer system that collected or generated the data should be compliant with the 21 CFR Part 11 guidelines. An audit trail must be maintained, and the place and time of origin should be noted.
2. Legible: This attribute refers to the readability and understandability of data. Data must be recorded in a durable medium and should be easily accessible in a human-readable format.
3. Contemporaneous: Data recording should be synchronous with data collection. The timing of each activity should be recorded, and any change to the original recording must be fully tracked and time-stamped.
4. Original: The original records must be preserved to maintain data integrity. If an electronic data collection module is being used, then it should accurately record the raw data and protect the original data from any modifications.
5. Accurate: All the data collected should be thorough, reliable, and error-free and must be an actual representation of the facts. When recording data electronically, data quality must be maintained by ensuring that the system has built-in accuracy checks and validation controls.
6. Complete: Controls should be in place ensuring that the data contains all details. All repeats or reanalysis performed should be included, and nothing must be deleted or removed from the date of documenting. An audit trail must be maintained, thereby demonstrating that data is complete.
7. Consistent: Data must be able to prove the correct sequence of events. Data should be arranged chronologically and must be dated and time-stamped in the expected sequence.
8. Enduring: To ensure that the data is accessible long after it is recorded, the material used to record that data should be long-lasting and durable. This can be accomplished by recording data in laboratory notebooks or using validated electronic systems with redundancy and backups.
9. Available: This principle of ALCOA+ dictates that the data should be accessible for review and inspection whenever needed. It should be easily retrievable over the lifetime of the record.
The breach of data integrity typically involves violations of one or more principles of ALCOA+. Some examples may include intentional deletion or manipulation of original records, accidental destruction or loss of data, uncontrolled documentation, or failure to record data contemporaneously. An efficient way to combat these common data integrity issues is to record data electronically. By providing access only to authorized and authenticated individuals, these systems maintain the completeness and consistency of the data, as well as prevent the possibility of data loss or unauthorized PHI disclosure. All data entries and changes made are mapped, time-stamped, and once stored, the data is easily accessible to authorized individuals; anytime, anywhere.
Clinical.ly is the answer to your data integrity needs!
Clinical.ly understands the importance of data integrity in clinical trials and will help you ensure your data’s quality, security, and integrity. In compliance with the ALCOA+ principles, we help make sure that your data is always complete, consistent, and accurate, while stored in a durable format that is accessible to authorized personnel at all times.
Arrange an initial consultation with us to explore how we can help you reduce the risk of data integrity violations.
