If corrections or revisions need to be made, changes shouldn’t obscure prior entries.
The source is the earliest record – the first place data is documented. Original Is it the first place data is recorded? On paper, data needs to be documented in real time and dated with the current date – no pre- or post-dating.Īutomatic 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.
#Paper source trial#
Contemporaneous Was it recorded as it happened?ĭata should be recorded, signed, and dated at the time of trial conduct, rather than risk an individual recalling the wrong information from memory. Electronic submissions ensure there is no room to second guess what number or letter someone actually means. Handwriting must be clear to reduce the likelihood of transcription errors and allow accurate study re-creation.Įlectronic source records typically solve the illegible handwriting problem, because data and information are presented in a clean and standardized format. Legible Is it clear enough to read?Įverything written on paper must be easy to read and recorded in a permanent medium – not in pencil.
#Paper source password#
Data is attributable to a unique user with a secure password and role-based permissions, preventing unauthorized users from making changes. A compliant system will automatically track this information and enable electronic signatures. Similarly, if something needs to be changed on the record, the change must be initialed, dated, and explained.Īudit 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. This requires a signature or initials, the date, and an identifier to a subject visit. When documenting data on paper, every written element needs to be traced back to the authorized individual responsible for recording it. 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? Attributable Is it traceable to a person, date, and subject visit? If these best practices for source documentation aren’t followed, there is no valid evidence the test article is safe and effective. Whether they’re recorded on paper or electronically, source data should follow ALCOA-C, an acronym used in clinical research for:
According to the Food and Drug Administration (FDA), data should meet certain fundamental elements of quality.
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