SOCRA CCRP Data Management 1

Question 1

What does 21 CFR Part 11 govern in clinical research?

Accepted Answer

Electronic records and electronic signatures

Answer

21 CFR Part 11 establishes FDA criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records.

Question 2

What is the 'audit trail' requirement under 21 CFR Part 11?

Accepted Answer

A computer-generated, time-stamped record of who created, modified, or deleted electronic data

Answer

An audit trail is a secure, computer-generated, time-stamped record that independently logs operator entries and actions to reconstruct the course of events.

Question 3

In clinical data management, what does 'source data' refer to?

Accepted Answer

Original information in original records and certified copies used as the basis of a clinical trial

Answer

Source data is the original information first recorded in source documents such as hospital records, clinical charts, lab notes, or diaries.

Question 4

What is a 'data query' in clinical trial data management?

Accepted Answer

A question raised to resolve a discrepancy or missing data in the case report form

Answer

A data query is a formal request sent to site personnel to clarify, correct, or provide missing information identified during data review.

Question 5

Which principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?

Accepted Answer

ALCOA principle

Answer

The ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate) defines the fundamental data quality standards in GCP.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Data Management 1