ACRP Source Documentation and Data Integrity 2 — Questions and Answers
Question 1: ALCOA-C extends the original ALCOA principles by adding which additional requirement?
- Consistent — data must be consistent across all documents
- Complete — all data must be fully documented without gaps or omissions (Correct answer)
- Compliant — data must meet all regulatory requirements
- Current — data must reflect only the most recent information
Correct answer: Complete — all data must be fully documented without gaps or omissions
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:
- CRFs are retained at the site while source documents are sent directly to the sponsor
- Source documents contain original data; CRFs capture data transcribed or entered from those source documents (Correct answer)
- CRFs require IRB approval for each entry while source documents do not
- Source documents are exclusively electronic while CRFs can be paper or electronic
Correct answer: Source documents contain original data; CRFs capture data transcribed or entered from those source documents
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:
- A copy that has been notarized by a licensed public notary
- A copy that has been verified as an exact and complete replica of the original, confirmed with a dated signature of an authorized person (Correct answer)
- Any photocopy or scan of an original document regardless of verification
- An electronic scan that has been approved by the IRB
Correct 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
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:
- SDV performed by a local monitor conducting an in-person visit at the investigative site
- SDV performed off-site by a monitor using electronic access to source documents (Correct answer)
- SDV conducted exclusively by the sponsor without involvement of a CRO
- SDV performed only on paper source documents stored at the site
Correct answer: SDV performed off-site by a monitor using electronic access to source documents
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:
- All electronic data is printed and filed in paper format as a backup
- Data cannot be altered by anyone after initial entry under any circumstances
- Audit trails, data trails, and edit trails are created and maintained to document all changes (Correct answer)
- All data entry is performed exclusively by the principal investigator
Correct answer: Audit trails, data trails, and edit trails are created and maintained to document all changes
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.
Question 6: A transcription error in a clinical trial occurs when:
- A participant refuses to sign the informed consent form
- Data is incorrectly transferred from a source document to the case report form (Correct answer)
- A laboratory test is performed using incorrect methodology
- The investigator fails to report a serious adverse event within the required timeframe
Correct answer: Data is incorrectly transferred from a source document to the case report form
Transcription errors occur during the manual transfer of data from source documents to CRFs, resulting in discrepancies between what the source shows and what the CRF records.
Question 7: If source data is found to be missing during a monitoring visit, the monitor's appropriate response is to:
- Enter estimated values into the CRF based on data from similar study participants
- Document the missing data as a monitoring finding and work with the site staff to locate or appropriately address it (Correct answer)
- Immediately close the investigative site and report to regulatory authorities
- Remove the affected subject from the study database without further investigation
Correct answer: Document the missing data as a monitoring finding and work with the site staff to locate or appropriately address it
Missing source data must be documented as a monitoring finding; the monitor should collaborate with the site to locate the original records or determine the appropriate course of action per protocol and SOPs.
ACRP Source Documentation and Data Integrity 2
ALCOA-C extends the original ALCOA principles by adding which additional requirement?