CCRA Data Management and Source Document Verification

Question 1

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

Accepted Answer

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

Answer

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.

Question 2

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

Accepted Answer

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

Answer

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.

Question 3

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

Accepted Answer

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

Answer

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.

Question 4

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

Accepted Answer

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

Answer

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.

Question 5

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

Accepted Answer

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

Answer

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.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Data Management and Source Document Verification