How Paper and Electronic Source Data Meet ALCOA-C Principles
According to the Food and Drug Administration (FDA), data should meet certain fundamental elements of quality. Whether they’re recorded on paper or electronically, source data should follow ALCOA-C, an acronym used in clinical research for:
If these best practices for source documentation aren’t followed, there is no valid evidence the test article is safe and effective.
What does each element of ALCOA-C mean, and how are the principals implemented differently for data originally collected on paper versus 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 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, the change must be initialed, dated, and explained.
Audit trails in an electronic system make it clear 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 unauthorized users from making changes.
Is it clear enough to read?
Everything written on paper must be easy to read and recorded in a permanent medium – not in pencil. Handwriting must be clear to reduce the likelihood of transcription errors and allow accurate study re-creation.
Electronic source records typically solve the illegible handwriting problem, because data and information are presented in a clean and standardized format. Electronic submissions ensure there is no room to second guess what number or letter someone actually means.
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 pre- or post-dating.
Automatic date and time stamps support this every time clinical data is entered, edited, or modified in an electronic system with appropriate controls in place to fully support 21 CFR Part 11 compliance.
Is it the first place data is recorded?
The source is the earliest record – the first place 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 right?
It’s critical the source completely reflects true observations. This means an honest, accurate, and thorough representation of facts describing the study conduct. There will be times when source documents are incomplete, inconsistent, or wrong. If changes need to be made, modifying a paper record always needs to be done in a compliant manner.
When the source is electronic, audit trails can provide transparency to prevent altering data 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.
Is everything correct and up to date?
Everyone involved in a study, including researchers and investigators, should strive to make sure data is accurate and complete. To ensure this, record data as soon as it happens. This will help prevent audit findings due to incomplete or missing data. Additionally, it will foster communication between all parties, strengthening relationships.
Each ALCOA-C principle must be applied to both paper and electronic source data, along with the records holding the data. Serving as evidence of the events taking place during a study, source documents need to paint the full picture of what happened. Using ALCOA-C as a guide to collecting quality data in clinical trials can help ensure a test article is safe and effective.
Advarra EDC allows users to build custom forms, set up edit checks, and use forms across multiple protocols to decrease duplicate data entry and error.