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

Only the Case Report Form (CRF)

Answer

The protocol and amendments only

Answer

Electronic data capture system printouts only

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

Eliminate the need for source document verification

Answer

Automatically correct data entry errors

Answer

Replace the paper CRF process entirely

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

It is created by the CRA during the monitoring visit

Answer

The original document has been destroyed

Answer

It is signed only by the CRA

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

Resolving IRB approval queries from site staff

Answer

Answering protocol questions from investigators

Answer

Resolving financial payment disputes between sponsor and sites

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

Use white-out to remove the error and write the correct value

Answer

Delete the entire page and resubmit a clean CRF

Answer

Corrections must be made only by the CRA

Question 6

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:

Accepted Answer

eSource data

Answer

Secondary data

Answer

Derived data

Answer

Transferred data