ALCOA+ Principles

The Principles

Good documentation drives good research and the saying goes “If it isn’t documented, it doesn’t exist."

The acronym ‘ALCOA’ defines that data should be Attributable, Legible, Contemporaneous, Original and Accurate. In addition, ‘ALCOA+’ guidance recommends that data is also Complete, Consistent, Enduring, and Available.

Study records are required to be recorded and maintained as per ICH-GCP and applicable regulatory requirements:

• EMA reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials (European Medicines Agency, 09 June 2010).

• ICH GCP E6 (R2) 4.9.0 references source data should be attributable, legible, contemporaneous, original, accurate and complete.

• Please check your local SOPs and regulations for further reference.

ALCOA Principles 

Attributable

• Who created the document and when? Source documents (SD) must be directly attributable to the individual who made the observation. Document who made a change, when it was made and why.

• For electronic data, the person undertaking the action should be recorded by the system (unique user identification). It is important that electronic data are time and date stamped when the data are generated.

• Monitors should be able to tell who recorded data or created a document and SD must be audit-ready in the event of an inspection.

Legible

• Recorded data should be legible. All SD must be clear and readable in order to be meaningful to an independent reviewer. An illegible piece is equivalent to no documentation.

Contemptuous

• Clinical research professionals should record results when they observe them and signatures must come with a date. They may be handwritten (in ink) or electronic. If you can't enter a clinical outcome as soon as it happens, you need to explain why it wasn't recorded right away in your documentation.

• Whether handwritten or electronically generated and later printed out, additions, deletions or corrections to source documents should be identified by initialing and dating the changes with a date on which they were made and previous data must still be legible (e.g., strikethrough- audit trail). Changes should be explained. An electronic system with audit trails makes it easy to enter data quickly and track when data was entered.

Original

• Original data are values that represent the first recording of study data and observation. It is permissible for original documents and the original data recorded on those documents to be replaced by certified copies provided that the copies are identical and have been verified as such (i.e., electronic medical health records). 

Accurate

• The documented information is an honest reflection of the original observation. Accurate data are required to achieve study objectives and ensure that others can replicate the results. The data should be captured in a consistent manner. Clinical research professionals must check all data they've entered on paper or in an electronic system to make sure they've recorded every data point correctly.

Additional Standards 

Complete

• Maintain accurate and complete source documents It should be possible to fully reconstruct the activities performed and to get a complete picture of what actually happened. ICH GCP reminds us that any changes to the sourced data must  be traceable, shouldn't obscure the original entry and be explained , if necessitated. 

Consistent

• All pieces of source documentation should match each other. They all should speak the same truth. Documents must demonstrate all required attributes consistently.

Enduring

• Documents should be durable and easy to access and read long after they're created. Source documents should be protected from destruction or damage. Sites must maintain a log of source and essential documents before, during and after the trial.

Available

• Physicians providing treatment and monitors performing audits or inspections must have easy access to documents. Source documents continue to be available, readable and understandable when required.