Data Management and Source Document Verification Flashcards

What qualifies as a 'source document' in a clinical trial?

Answer: Original records and certified copies of original information including medical records, lab reports, and subject diaries

Source documents are original records from which subject data are first captured, including hospital records, clinic charts, laboratory notes, diaries, pharmacy records, and imaging results.

In a clinical trial using an Electronic Data Capture (EDC) system, audit trails serve to:

Answer: Record all data entries, changes, deletions, and the identity of the person making changes with timestamps

EDC audit trails create an automatic, computer-generated, time-stamped record of all actions taken in the system, supporting data integrity and regulatory inspection readiness.

A 'certified copy' of a source document is acceptable when:

Answer: It is a verified copy that has been confirmed as an exact copy of the original through a documented process

A certified copy is a copy verified to be a true and accurate copy of the original through a documented certification process, and it may be retained in place of the original when needed.

What does 'query resolution' involve in clinical data management?

Answer: Identifying, clarifying, and correcting data discrepancies or missing data in CRFs through a formal communication process

Query resolution is the process by which data managers or CRAs flag data issues in the CRF/EDC, sites investigate and correct the data, and the resolution is documented with an explanation.

What is the regulatory requirement for corrections made to paper CRF data?

Answer: Draw a single line through the error, write the correct value, initial, and date the correction

GCP requires that CRF corrections preserve the original entry; the correct method is a single line through the error so the original is still legible, with the correction, date, and initials of the person making the change.

When EDC is used as the source of truth and data are entered directly into the EDC system without prior paper records, these data are called:

Answer: eSource data

eSource refers to clinical trial data captured directly in electronic systems (e.g., EDC, EHR) as the original source, without an intermediate paper record being created.