SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Source Documentation and Data 1

Question 1

Which additional attributes extend the basic ALCOA principles to 'ALCOA+' in clinical research source documentation?

Accepted Answer

Complete, Consistent, Enduring, and Available

Answer

ALCOA+ expands on the foundational ALCOA framework by adding Complete, Consistent, Enduring, and Available — attributes that ensure data is not only accurate at the moment of recording but remains intact, coherent across records, and accessible throughout the study lifecycle.

Question 2

According to GCP guidelines, what is the correct way to correct an error in a paper source document?

Accepted Answer

Draw a single line through the error, write the correction nearby, and add initials, date, and reason for change

Answer

GCP requires that the original entry remain legible after any correction. A single line through the error, followed by the corrected value, the corrector's initials, the date, and the reason for the change preserves the audit trail and demonstrates transparency.

Question 3

How is a 'certified copy' of a source document defined under ICH E6 GCP?

Accepted Answer

A verified copy confirmed to be an exact reproduction of the original, preserving all content and context

Answer

A certified copy is any copy — paper, microfilm, or electronic — that has been verified to contain all the same information as the original, including data describing its context, content, and structure. Verification confirms the copy is a true and complete reproduction.

Question 4

Under 21 CFR Part 11, which requirement is essential for electronic source records to be considered trustworthy in a clinical trial?

Accepted Answer

A secure, computer-generated, time-stamped audit trail must capture all entries and changes to electronic records

Answer

21 CFR Part 11 mandates a secure, computer-generated, time-stamped audit trail that independently records operator actions — creation, modification, or deletion — without the ability to be altered. This ensures data integrity and supports regulatory inspection of the full data history.

Question 5

During Source Data Verification (SDV), what specific comparison does the CRA perform?

Accepted Answer

Data recorded in the Case Report Form against the original source documents at the investigative site

Answer

SDV requires the CRA to compare data entered in the CRF directly against the original source documents to confirm that transcription was accurate, complete, and unaltered. This process is the primary mechanism for detecting data entry errors and unauthorized changes.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Source Documentation and Data 1