Tag: Question 0428

Systems Security Certified Practitioner – SSCP – Question0428

Attributable data should be:

A. always traced to individuals responsible for observing and recording the data
B. sometimes traced to individuals responsible for observing and recording the data
C. never traced to individuals responsible for observing and recording the data
D. often traced to individuals responsible for observing and recording the data

Correct Answer: A

Explanation:

As per FDA data should be attributable, original, accurate, contemporaneous and legible. In an automated system attributability could be achieved by a computer system designed to identify individuals responsible for any input. Source: U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry -Computerized Systems Used in Clinical Trials, April 1999, page 1.