ALCOA+

ALCOA+ is a framework or set of principles that ensures data integrity. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration. It has relevance in a range of areas particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain. As well as being essential for compliance reasons, the ALCOA+ principles are becoming increasingly important to GCP (Good Clinical Practices).

The Importance of Data Integrity

Data has always been important in clinical. A range of different factors, however, means the importance of data is growing exponentially. The drivers for this include enhanced regulatory requirements in addition to the evolving expectations of consumers and end users as well as the increasingly competitive nature of the pharmaceutical industry.

You can’t just have data, though. Instead, you need to have data and you need to ensure the integrity of that data. When you have this, you have data you can use and rely on.

The ALCOA principles ensure data integrity. They apply to the following types of GCP records:

  • Electronically recorded – data recorded using equipment that ranges from simple machines through to complex and highly configurable computerized systems
  • Paper-based – a manual recording on paper of a manual observation or of an activity
  • Hybrid – where both paper-based and electronic records constitute the original record
  • Others – this includes photography, images, scanned documents, and more

The ALCOA Principles

ALCOA is an acronym for the original five principles of data integrity. Those principles are:

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate

However, the original ALCOA principles have since been updated to ALCOA+. The original principles remain with four additions:

  • Complete
  • Consistent
  • Enduring
  • Available

How is Trial Interactive compliant with ALCOA++ principles?

Attributable: When creating a record, you must record the identity of the person or computer system that collected or generated the data. It’s also important to record the date of the collection or generation.

Trial Interactive holds metadata for each document in a closed system that binds the record to the identity of the individual making the change and records all interactions in a human readable audit trail.

Legible: Ensuring data is legible is about more than being able to clearly read the data, although that is important in situations where manual data record-keeping takes place. Being able to make out the words is much less of a problem with electronic data, though. That said, ensuring data is legible still has relevance. This is because it must be possible for data to be read and understood years and even decades after it’s recorded. This can have as much relevance to digitally recorded data as it does to data recorded in notebooks.

Trial Interactive provides a clear workflow to customers for the accurate indexing and metadata definition for each and every document. All metadata is shown with the content in a legible way. Additionally, tools are provided for the OCR and Machine Translation of all content.

Contemporaneous: It’s essential that individuals or systems make a record of an activity at the time it takes place. With electronic data, this is normal practice, so this is another point that has more relevance to manual record-keeping.

All content and metadata in Trial Interactive is securely stored in a self-auditing database that automatically audits and versions all changes immediately.

Original: Records should be original rather than copies or transcriptions. Again, this applies mostly to manual record-keeping. For example, you should not write a record on a scrap of paper with the intention of completing the main record later, as this can result in errors. Instead, the original recording of the data should be on the main record, whether that record is on paper or on a digital system.

Trial Interactive supports a simple process for certifying that electronic copies of documents are equivalent to their original paper copies, allowing the paper copies to be destroyed if desired by the customer, and thus preserving the electronic as the original, certified source document.

Accurate: All records should reflect the reality of what happened and should be error free. Also, there should be no editing of the original information that results in that information being lost. If changes are necessary, those changes must be documented in a way that makes it possible to refer back to the original information. Nothing should be removed, blocked out, or deleted. When recording data electronically, the system must have built-in accuracy checks and verification controls.

Trial Interactive captures the original version of any content or document that has been changed, permanently storing the original for later reference. In cases where a document must be redacted to ensure the security of Personal Health Information (PHI) or PII, the original copy is still stored within Trial Interactive in a secure, encrypted fashion.

Complete: All recorded data requires an audit trail to show nothing has been deleted or lost.

In addition to the self-auditing database, Trial Interactive captures the SHA-2 hash of every piece of data stored within Trial Interactive, allowing for the verification that nothing has been deleted or lost.

Consistent: This primarily means ensuring data is chronological, i.e. has a date and time stamp that is in the expected sequence.

Every piece of data stored in Trial Interactive is stored with a date/time stamp and the identity of the user or entity who last changed it.

Enduring: While this is touched on in a previous principle, this principle of ALCOA+ places specific emphasis on ensuring data is available long after it is recorded – decades in some situations.

Documents stored within Trial Interactive are converted to the standard PDF Archive (PDF/A) format for long term storage, which is been accepted as an archive standard by most governments including the USA and EU, ensuring access and interpretation of the content for a minimum of 25 years. Once archived, the metadata for each document is exported by customers to a human-readable CSV (Comma Separated Value) or HTML file for long term access.

Available: This point follows on from the last point, i.e. data must not only exist, it must be accessible. The most efficient way of achieving this is normally by recording data electronically.

Trial Interactive ensures that all content is accessible on it’s Cloud servers long term, and if desired, has a process for archiving this content to a Compact Disc, DVD, or USB Drive using a common FAT32 format.

Data integrity is essential to all validation processes in clinical. Following the ALCOA+ principles is the best way to achieve this goal.