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

Consistent — data must be consistent across all documents

Answer

Compliant — data must meet all regulatory requirements

Answer

Current — data must reflect only the most recent information

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

CRFs are retained at the site while source documents are sent directly to the sponsor

Answer

CRFs require IRB approval for each entry while source documents do not

Answer

Source documents are exclusively electronic while CRFs can be paper or electronic

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 copy that has been notarized by a licensed public notary

Answer

Any photocopy or scan of an original document regardless of verification

Answer

An electronic scan that has been approved by the IRB

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

SDV performed by a local monitor conducting an in-person visit at the investigative site

Answer

SDV conducted exclusively by the sponsor without involvement of a CRO

Answer

SDV performed only on paper source documents stored at the site

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

All electronic data is printed and filed in paper format as a backup

Answer

Data cannot be altered by anyone after initial entry under any circumstances

Answer

All data entry is performed exclusively by the principal investigator

Question 6

A transcription error in a clinical trial occurs when:

Accepted Answer

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

Answer

A participant refuses to sign the informed consent form

Answer

A laboratory test is performed using incorrect methodology

Answer

The investigator fails to report a serious adverse event within the required timeframe

Question 7

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

Accepted Answer

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

Answer

Enter estimated values into the CRF based on data from similar study participants

Answer

Immediately close the investigative site and report to regulatory authorities

Answer

Remove the affected subject from the study database without further investigation