Source Documentation and Data Integrity Flashcards

ALCOA-C extends the original ALCOA principles by adding which additional requirement?

Answer: Complete — all data must be fully documented without gaps or omissions

ALCOA-C adds 'Complete' to the original five principles, emphasizing that no required data should be omitted and records must not contain gaps.

The key distinction between source documents and case report forms (CRFs) in clinical research is:

Answer: Source documents contain original data; CRFs capture data transcribed or entered from those source documents

Source documents are where data is originally recorded, while CRFs are used to capture data transcribed from those sources for reporting to the sponsor.

In clinical research, a 'certified copy' is defined as:

Answer: A copy that has been verified as an exact and complete replica of the original, confirmed with a dated signature of an authorized person

A certified copy is verified by an authorized person as an exact and complete copy of the original, making it acceptable as a regulatory equivalent to the original document.

Remote Source Data Verification (rSDV) refers to:

Answer: SDV performed off-site by a monitor using electronic access to source documents

Remote SDV allows monitors to review and verify source documents electronically from an off-site location, reducing the frequency of on-site visits while maintaining data oversight.

ICH E6(R2) requires that electronic systems used to manage source data must ensure:

Answer: Audit trails, data trails, and edit trails are created and maintained to document all changes

ICH E6(R2) requires that electronic systems maintain audit trails, data trails, and edit trails to ensure that all changes to electronic data are documented and traceable.

A transcription error in a clinical trial occurs when:

Answer: Data is incorrectly transferred from a source document to the case report form

Transcription errors occur during the manual transfer of data from source documents to CRFs, resulting in discrepancies between what the source shows and what the CRF records.

If source data is found to be missing during a monitoring visit, the monitor's appropriate response is to:

Answer: Document the missing data as a monitoring finding and work with the site staff to locate or appropriately address it

Missing source data must be documented as a monitoring finding; the monitor should collaborate with the site to locate the original records or determine the appropriate course of action per protocol and SOPs.