SOCRA Essential Study Documents 3

Question 1

Which of the following best defines 'source data' according to ICH E6 GCP?

Accepted Answer

Original records and certified copies of original records of clinical findings

Answer

ICH E6 defines source data as all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial.

Question 2

According to ALCOA principles, how should an error in a paper CRF be corrected?

Accepted Answer

Draw a single line through the error, write the correct value, and initial/date the correction

Answer

GCP requires errors be corrected with a single line through the original entry so it remains legible, followed by the correct value, the corrector's initials, and date.

Question 3

A CRA discovers that a CRF entry differs from the source document. What is the correct first step?

Accepted Answer

Issue a data query to the site to clarify the discrepancy

Answer

The CRA should issue a data query to the site so the discrepancy can be reviewed, explained, and corrected by authorized site staff.

Question 4

What is the primary purpose of an audit trail in an electronic data capture (EDC) system?

Accepted Answer

To create a secure, time-stamped record of all data entries and changes

Answer

An audit trail provides a chronological, secure record showing who entered, changed, or deleted data and when, ensuring data integrity and traceability.

Question 5

Which of the following is NOT considered source data for a clinical trial?

Accepted Answer

A completed case report form (CRF)

Answer

A CRF is a transcription of source data, not source data itself, unless it is designated as the original source for a specific data point.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Essential Study Documents 3