According to the FDA, data should meet certain fundamental elements of quality. Whether they’re recorded on paper or electronically, source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA). If these best practices for source documentation aren’t followed, there is no valid evidence that the test article is safe and effective.
What does each element of ALCOA mean, and how are they implemented differently for data originally collected on paper vs. first recorded electronically?
Is it traceable to a person, date, and subject visit?
When documenting data on paper, every written element needs to be traced back to the authorized individual who is responsible for recording it. This requires a signature or initials, the date, and an identifier to a subject visit. Similarly, if something needs to be changed on the record, it needs to be initialed, dated, and should explain the reason for the change.
Audit trails in an electronic system make it very obvious who created a record, when it was created, who made a change, when the change was made, and the reason a change was made. A compliant system will automatically track this information and enable electronic signatures. Data is attributable to a unique user with a secure password and role-based permissions, preventing changes from being made by unauthorized users.
Is it clear enough to read?
On paper, everything that’s written must be easy to read and recorded in a permanent medium (not pencil). Handwriting must be clear to reduce the likelihood of transcription errors and allow a study to be accurately re-created.
Electronic source records typically solve the illegible handwriting problem, because data and information are presented in a clean and standardized format.
Was it recorded as it happened?
Data should be recorded, signed, and dated at the time of trial conduct, rather than risk an individual recalling the wrong information from memory. On paper, data needs to be documented in real-time and dated with the current date (no predating or postdating).
Automatic date and time stamps support this every time clinical data is entered, edited, or modified in an electronic system that has the appropriate controls in place to fully support compliance with 21 CFR Part 11.
Is it the first place data is recorded?
The source is the earliest record – the first place that data is documented. If corrections or revisions need to be made, changes shouldn’t obscure prior entries. Paper source documents should be preserved and kept in their original form.
When the first record is electronic, an audit trail can track any and all subsequent queries and changes.
Are all the details correct?
It’s critical that the source completely reflects the true observations. This means an honest, accurate, and thorough representation of facts describing the conduct of the study. There will be times when source documents are incomplete, inconsistent, or wrong. If changes need to be made, modifying a paper record always need to be done in a compliant manner.
When the source is electronic, audit trails can provide transparency to prevent data from being altered in a way that is difficult to detect. Additionally, automatic edit checks can immediately alert when missing data points or out-of-range data are entered.
All of the elements of the acronym ALCOA must be applied to both paper and electronic source data, and the records that hold that data. Serving as evidence of the events that took place during a study, source documents need to paint the full picture of what happened. Using ALCOA as a guide to collecting quality data in clinical trials can help justify that a test article is safe and effective.
For more information on eSource, see: Guidance for Industry on Electronic Source Data in Clinical Investigation