ACRP Source Documentation and Data Integrity 2

Question 1

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

Accepted Answer

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

Answer

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

Question 2

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

Accepted Answer

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

Answer

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

Question 3

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

Accepted 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

Answer

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.

Question 4

Remote Source Data Verification (rSDV) refers to:

Accepted Answer

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

Answer

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.

Question 5

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

Accepted Answer

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

Answer

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.

ACRP - Association of Clinical Research Professionals Practice Test

ACRP - Association of Clinical Research Professionals Practice Test

ACRP Source Documentation and Data Integrity 2